IMOVE: Improvisational Movement for People With Memory Loss and Their Caregivers

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03333837
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
104
1
4
39.6
2.6

Study Details

Study Description

Brief Summary

Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Changes in mood, gait, and balance are prominent secondary symptoms of Alzheimer's dementia that can dramatically decrease quality of life for the person with dementia and increase caregiver burden. The overall aim of this study is to determine the independent and combined effects of dance movement and social engagement on quality of life in people with early-stage dementia, and test the neural mechanisms of these effects.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dance Group
  • Behavioral: Non-Group Dance
  • Behavioral: Social Group
  • Behavioral: No Contact
N/A

Detailed Description

Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Alzheimer's disease is the most common form of dementia, the most common neurodegenerative disease in older adults, and the 6th leading cause of death in the US. Neuropsychiatric symptoms (apathy, depression, anxiety) and altered gait and balance are prominent secondary symptoms of Alzheimer's disease that increase medical costs and decrease quality of life for both the person with dementia and their caregiver.

In a report from the Secretariat (Executive Board, 134th Session, December 20th, 2013), the World Health Organization identified a need to integrate evidence-based palliative care services into the continuum of care for serious chronic diseases, including Alzheimer's disease. However, two recent NIH workshops identified major gaps in the evidence supporting the wider use of non-pharmacologic activities to ameliorate secondary symptoms of chronic disease. Arts-based activities were identified as particularly understudied for symptom management, given growing evidence that various arts-based activities can improve quality of life, relieve symptoms, and reduce reliance on medications. It is important that these benefits can be achieved without adding medications. Dance is an arts-based activity that can improve quality of life, decrease symptoms of depression, and improve balance in healthy older adults, those with Parkinson disease, and Alzheimer's disease. Thus, dance is a non-pharmacological intervention that simultaneously addresses two sets of prominent secondary symptoms in Alzheimer's disease: 1) gait and balance and 2) neuropsychiatric symptoms. However, the mechanisms through which dance exerts these effects are unknown.

Pilot data from the investigators' laboratory suggest that participating in a group improvisational movement class twice weekly improved balance and connectivity in motor-related brain regions, as well as improving mood and connectivity in brain regions associated with social engagement. Improvisation is the ability to create new gestures and movements spontaneously. Improvisation can be a part of many different art forms. However, improvisational movement can also be practiced as a specific dance form. The objective in improvisational movement is that choreographed movement is replaced by a cue or prompt that allows the possibility for multiple responses. This unique form of dance is especially well-suited for people with dementia because it: 1) does not rely heavily on memory of repeated movements; 2) can be seamlessly adapted to include sitting, standing, or moving around the room; 3) is cognitively challenging; and 4) fosters a social, playful atmosphere. Participants seemed to benefit from both the social nature of the class and the movement. Therefore, the overall aim of this proposal is to experimentally determine the independent and combined effects of dance movement and social engagement on quality of life in people with early stage dementia, and test the neural mechanisms of these effects.

To accomplish this goal, the investigators will use a 2x2 factorial design and randomize 120 community-dwelling older adults adjudicated as having early-stage dementia of the presumed Alzheimer's type to one of four 3-month interventions: 1) Dance Group, 2) Non-group Dance, 3) Social Group, or 4) No Contact Control.

It is not hypothesized that dance affects the underlying disease course, and therefore no improvement is expected in cognition.

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trial. Investigators will use a 2x2 factorial design to test the separate and combined effects of social engagement and dance movement on QoL in 120 community-dwelling older adults adjudicated as having mild cognitive impairment (MCI) or early-stage dementia of the presumed AD or mixed AD/vascular type. Participants will be randomized to one of four 12-week interventions: 1) Dance Group 2) Non-group Dance, 3) Social Group, or 4) No Contact Control.Randomized controlled trial. Investigators will use a 2x2 factorial design to test the separate and combined effects of social engagement and dance movement on QoL in 120 community-dwelling older adults adjudicated as having mild cognitive impairment (MCI) or early-stage dementia of the presumed AD or mixed AD/vascular type. Participants will be randomized to one of four 12-week interventions: 1) Dance Group 2) Non-group Dance, 3) Social Group, or 4) No Contact Control.
Masking:
Single (Outcomes Assessor)
Masking Description:
All study assessments will be conducted by experienced staff certified annually on the proper conduct of study assessments and blinded to group assignment.
Primary Purpose:
Supportive Care
Official Title:
IMOVE: Improvisational Movement for People With Memory Loss and Their Caregivers
Actual Study Start Date :
Feb 6, 2018
Actual Primary Completion Date :
May 26, 2021
Actual Study Completion Date :
May 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dance Group

The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing.

Behavioral: Dance Group
Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.

Active Comparator: Non-group Dance

The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week.

Behavioral: Non-Group Dance
The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.

Active Comparator: Social Group

The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.

Behavioral: Social Group
The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.

Sham Comparator: No Contact

A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks

Behavioral: No Contact
The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.

Outcome Measures

Primary Outcome Measures

  1. Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD) [Baseline]

    Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.

  2. QOL-AD--PWD [Week 12]

    Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.

Secondary Outcome Measures

  1. Community Structure--PWD [Baseline]

    This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.

  2. Community Structure--PWD [Week 12]

    This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.

  3. Global Efficiency (eGlob)--PWD [Baseline]

    This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.

  4. Global Efficiency (eGlob)--PWD [Week 12]

    This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.

  5. Local Efficiency (eLoc)--PWD [Baseline]

    Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.

  6. Local Efficiency (eLoc)--PWD [Week 12]

    Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.

  7. Path Length--PWD [Baseline]

    Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.

  8. Path Length--PWD [Week 12]

    Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.

  9. Fullerton Advanced Balance Scale (Overall Balance) PWD [Baseline]

    Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls.

  10. Fullerton Advanced Balance Scale (Overall Balance) PWD [Week 12]

    Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls.

  11. Falls Efficacy Scale - International (FES) PWD [Baseline]

    A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.

  12. Falls Efficacy Scale - International (FES) PWD [Week 12]

    A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.

  13. Neuropsychiatric Inventory Questionnaire (NPI-Q) [Baseline]

    The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity.

  14. NPI-Q [Week 12]

    The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity.

  15. Geriatric Depression Scale [Baseline]

    The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.

  16. Geriatric Depression Scale [Week 12]

    The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.

  17. Geriatric Anxiety Scale [Baseline]

    The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).

  18. Geriatric Anxiety Scale [Week 12]

    The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).

  19. Apathy Evaluation Scale--PWD [Baseline]

    The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.

  20. Apathy Evaluation Scale--PWD [Week 12]

    The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.

  21. Expanded Short Physical Performance Battery (eSPPB) [Baseline]

    The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome.

  22. Expanded Short Physical Performance Battery (eSPPB) [Week 12]

    The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome.

  23. Postural Sway--PWD [Baseline]

    Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway.

  24. Postural Sway--PWD [Week 12]

    Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway.

  25. Gait Speed--PWD [Baseline]

    The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB.

  26. Gait Speed--PWD [Week 12]

    The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB.

  27. Gait Variability--PWD [Baseline]

    Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults.

  28. Gait Variability--PWD [Week 12]

    Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults.

Other Outcome Measures

  1. Body Mass Index (BMI) [Baseline, Week 12]

    a measure of body fat based on height and weight that applies to adult men and women--PWD only

  2. Blood Pressure [Baseline, Week12]

    PWD only

  3. Neuroticism-Extraversion-Openness Five-Factor Inventory (NEO-FFI) [Baseline]

    A measure of five domains of personality (neuroticism, extraversion, openness, agreeableness, and conscientiousness). A higher score on any scale indicates stronger presence of that trait. PWD only

  4. White Matter Lesion Burden [Baseline, Week 12]

    The volume of white matter lesions is calculated using the Lesion Segmentation Toolbox. PWD only.

  5. Blood-based Stress Biomarkers (Covariate or Alternative Hypothesis) [Baseline, Week 12]

    Social engagement may change biomarkers of stress relevant for interpreting outcomes. These stress biomarkers include cortisol and allostatic load, a composite measure of blood-based biomarkers associated with chronically elevated stress. PWD only

  6. Caregiver Quality of Life With the 36-item Short-Form Health (SF-36)--Covariate or Alternative Hypothesis [Baseline, Week 12]

    The SF-36 consists of 36 questions assessing physical functioning, role functioning difficulties caused by physical problems, bodily pain, general health, vitality, social functioning, role functioning difficulties caused by emotional problems, and mental health. High scores are representative of a great health status and better outcomes, while low scores are representative of a poor health status.

  7. Caregiver Burden With Zarit Caregiver Burden Scale--Covariate or Alternative Hypothesis [Baseline, Week 12]

    The Zarit Caregiver Burden Scale is administered in interview form to the caregiver. It consists of 22 questions scored 0-4 with 0=Never, 1=Rarely, 2=Sometimes, 3=Quite Frequently, 4=Nearly Always. The total score range is 0-88 with 88 being the worst possible outcome. 0-20 represents little or no burden on the caregiver, 21-40 represents mild to moderate burden, 41-60 represents moderate to severe burden, and 61-88 represents severe burden.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Age 60-85 years

Adjudicated as having mild cognitive impairment or early-stage dementia of Alzheimer's, vascular, or mixed Alzheimer's/vascular type

MRI compatible

English speaking

Have study partner who is around the person with dementia approximately 10 hours/week and is willing to be an active study partner.

Able to attend bi-weekly intervention classes or come to study visits for no-contact control.

Not enrolled in another interventional study for at least 3 months prior to beginning this study.

Exclusion Criteria:

Untreated depression

Other causes of dementia (for example, frontotemporal, early onset, Lewy body or Parkinsonian dementia)

Current cancer treatment or other major medical problems that might independently affect cognition or movement

Other neurological disorders (e.g., Parkinson disease, multiple sclerosis)

Taking medication that could negatively influence safety during intervention

Planned extensive travel during the study period

Any reason for which the study doctor or personal physician feels the intervention is contraindicated for the participant

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest Baptist Health Winston-Salem North Carolina United States 27104

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Christina Hugenschmidt, PhD, Assistant Professor Gerontology and Geriatric Medicine

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT03333837
Other Study ID Numbers:
  • IRB00042460
  • R01AT009444
First Posted:
Nov 7, 2017
Last Update Posted:
Jul 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details All Persons With Dementia (PWDs) were enrolled with one caregiver each. There was never a time when one was enrolled without the other, so these two people are represented in the participant flow as a dyad.
Pre-assignment Detail Participants were enrolled in dyads consisting of one person with dementia (PWD) and one caregiver (CG). Participant flow section includes numbers as dyad since both were considered enrolled. Elsewhere in the record, numbers include either participants with dementia or caregivers as indicated in baseline analysis population description and in outcome titles or descriptions.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact Never Randomized
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like. Subject dyads who signed consent but withdrew prior to randomization.
Period Title: Overall Study
STARTED 24 25 27 25 3
COMPLETED 22 22 22 23 0
NOT COMPLETED 2 3 5 2 3

Baseline Characteristics

Arm/Group Title Dance Group Non-group Dance Social Group No Contact Never Randomized Total
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like. Subject dyads who signed consent but withdrew prior to randomization. Total of all reporting groups
Overall Participants 24 25 27 25 3 104
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
75.33
(5.94)
73.62
(7.10)
76.75
(6.29)
76.0
(6.43)
69.87
(3.23)
75.29
(6.45)
Sex: Female, Male (Count of Participants)
Female
12
50%
13
52%
14
51.9%
11
44%
0
0%
50
48.1%
Male
12
50%
12
48%
13
48.1%
14
56%
3
100%
54
51.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Not Hispanic or Latino
24
100%
24
96%
27
100%
25
100%
3
100%
103
99%
Unknown or Not Reported
0
0%
1
4%
0
0%
0
0%
0
0%
1
1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
1
4.2%
0
0%
1
3.7%
0
0%
0
0%
2
1.9%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
2
8.3%
3
12%
6
22.2%
2
8%
0
0%
13
12.5%
White
21
87.5%
22
88%
20
74.1%
23
92%
3
100%
89
85.6%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
24
100%
25
100%
27
100%
25
100%
3
100%
104
100%

Outcome Measures

1. Primary Outcome
Title Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD)
Description Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Results at baseline for this outcome represent all PWD who were randomized.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 27 25
Mean (Standard Deviation) [score on a scale]
35.42
(5.02)
38.10
(4.60)
35.56
(4.15)
36.12
(5.75)
2. Primary Outcome
Title QOL-AD--PWD
Description Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed corresponds to the number of participants who completed the study.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 22 22 22 23
Mean (Standard Deviation) [score on a scale]
35.23
(6.54)
40.0
(5.36)
36.68
(4.76)
35.96
(8.04)
3. Secondary Outcome
Title Community Structure--PWD
Description This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 23 21
Mean (Standard Deviation) [Q-Value]
.74
(.05)
.72
(.05)
.73
(.05)
.74
(.04)
4. Secondary Outcome
Title Community Structure--PWD
Description This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Numbers at baseline and week 12 differ due to withdrawals, poor data quality, and inability to complete scans.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 20 20 18 19
Mean (Standard Deviation) [Q-Value]
.74
(.04)
.73
(.05)
.75
(.04)
.75
(.03)
5. Secondary Outcome
Title Global Efficiency (eGlob)--PWD
Description This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 23 21
Mean (Standard Deviation) [score on a scale]
.19
(.02)
.18
(.03)
.19
(.03)
.19
(.03)
6. Secondary Outcome
Title Global Efficiency (eGlob)--PWD
Description This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Number at baseline and follow-up differ due to withdrawals, poor data quality, participant refusal of procedure, inability to complete scan.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 20 20 18 19
Mean (Standard Deviation) [score on a scale]
.19
(.03)
.18
(.03)
.19
(.02)
.19
(.03)
7. Secondary Outcome
Title Local Efficiency (eLoc)--PWD
Description Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 23 21
Mean (Standard Deviation) [units on a scale]
.59
(.03)
.57
(.04)
.59
(.03)
.58
(.04)
8. Secondary Outcome
Title Local Efficiency (eLoc)--PWD
Description Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Number at baseline and follow-up differ due to withdrawals, poor data quality, participant refusal of procedure, inability to complete scan.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 20 20 18 19
Mean (Standard Deviation) [units on a scale]
.58
(.03)
.58
(.03)
.59
(.03)
.58
(.04)
9. Secondary Outcome
Title Path Length--PWD
Description Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 23 21
Mean (Standard Deviation) [Number of Edges]
5.29
(.58)
5.69
(1.17)
5.42
(.78)
5.52
(.93)
10. Secondary Outcome
Title Path Length--PWD
Description Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Number at baseline and follow-up differ due to withdrawals, poor data quality, participant refusal of procedure, inability to complete scan.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 20 20 18 19
Mean (Standard Deviation) [Number of Edges]
5.30
(.93)
5.61
(.80)
5.36
(.54)
5.54
(1.09)
11. Secondary Outcome
Title Fullerton Advanced Balance Scale (Overall Balance) PWD
Description Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
One participant is missing baseline data due to a recording error during data collection.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 27 24
Mean (Standard Deviation) [score on a scale]
23.71
(8.22)
27.88
(5.40)
24.22
(6.32)
26.79
(4.57)
12. Secondary Outcome
Title Fullerton Advanced Balance Scale (Overall Balance) PWD
Description Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Number at baseline and week 12 differ due to withdrawals.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 22 22 22 23
Mean (Standard Deviation) [score on a scale]
23.41
(8.57)
29.95
(4.33)
24.27
(6.26)
26.78
(6.65)
13. Secondary Outcome
Title Falls Efficacy Scale - International (FES) PWD
Description A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 27 25
Mean (Standard Deviation) [score on a scale]
27.54
(10.06)
22.64
(4.86)
26.07
(7.76)
25.56
(8.65)
14. Secondary Outcome
Title Falls Efficacy Scale - International (FES) PWD
Description A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed corresponds to the number of participants who completed the study.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 22 22 22 23
Mean (Standard Deviation) [score on a scale]
27.23
(10.38)
21.73
(5.32)
25.36
(5.27)
28.09
(11.42)
15. Secondary Outcome
Title Neuropsychiatric Inventory Questionnaire (NPI-Q)
Description The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 27 25
Mean (Standard Deviation) [score on a scale]
6.83
(5.64)
5.44
(4.44)
6.85
(4.86)
7.72
(6.13)
16. Secondary Outcome
Title NPI-Q
Description The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Number at baseline and follow-up differ due to withdrawals and due to staff error during data collection.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 21 22 22 23
Mean (Standard Deviation) [score on a scale]
6.38
(5.48)
5.22
(4.66)
5.63
(5.71)
8.39
(5.25)
17. Secondary Outcome
Title Geriatric Depression Scale
Description The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Results at baseline for this outcome represent all PWD who were randomized.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 27 25
Mean (Standard Deviation) [score on a scale]
2.17
(2.50)
1.24
(1.05)
2.37
(2.13)
2.04
(2.28)
18. Secondary Outcome
Title Geriatric Depression Scale
Description The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed corresponds to the number of participants who completed the study.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 22 22 22 23
Mean (Standard Deviation) [score on a scale]
2.27
(2.76)
1.32
(1.36)
1.68
(1.29)
2.74
(3.54)
19. Secondary Outcome
Title Geriatric Anxiety Scale
Description The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Results at baseline for this outcome represent all PWD who were randomized.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 27 25
Mean (Standard Deviation) [score on a scale]
3.71
(3.34)
2.92
(2.06)
4.04
(3.01)
3.56
(3.31)
20. Secondary Outcome
Title Geriatric Anxiety Scale
Description The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed corresponds to the number of participants who completed the study.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 22 22 22 23
Mean (Standard Deviation) [score on a scale]
3.64
(3.63)
2.23
(1.57)
3.64
(3.27)
4.0
(4.65)
21. Secondary Outcome
Title Apathy Evaluation Scale--PWD
Description The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Results at baseline for this outcome represent all PWD who were randomized.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 27 25
Mean (Standard Deviation) [score on a scale]
21.83
(8.49)
18.88
(6.23)
19.74
(7.04)
18.44
(7.53)
22. Secondary Outcome
Title Apathy Evaluation Scale--PWD
Description The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
One participant is missing follow-up data due to a recording error during data collection.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 22 22 22 22
Mean (Standard Deviation) [score on a scale]
19.32
(9.89)
19.0
(6.61)
18.68
(6.24)
22.87
(7.50)
23. Secondary Outcome
Title Expanded Short Physical Performance Battery (eSPPB)
Description The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 27 25
Mean (Standard Deviation) [score on a scale]
1.57
(.55)
1.99
(.37)
1.67
(.46)
1.86
(.40)
24. Secondary Outcome
Title Expanded Short Physical Performance Battery (eSPPB)
Description The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Number at baseline and follow-up differ due to withdrawals, staff error, participant unwilling to complete, and participant unable to complete test.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 22 22 21 21
Mean (Standard Deviation) [score on a scale]
1.62
(.57)
1.98
(.39)
1.66
(.44)
1.88
(.50)
25. Secondary Outcome
Title Postural Sway--PWD
Description Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Number of participants analyzed at baseline differs due to technical error.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 22 25 26 25
Mean (Standard Deviation) [centimeter squared]
0.42
(0.37)
0.37
(0.14)
0.36
(0.21)
0.49
(0.44)
26. Secondary Outcome
Title Postural Sway--PWD
Description Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Numbers averaged at baseline and follow-up differ due to withdrawals, technical errors, safety concern, participant unwilling and participant unable to continue.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 21 20 22 21
Mean (Standard Deviation) [centimeter squared]
0.41
(0.22)
0.38
(0.20)
0.41
(0.26)
0.52
(0.42)
27. Secondary Outcome
Title Gait Speed--PWD
Description The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 24 25 27 25
Mean (Standard Deviation) [seconds]
5.47
(1.55)
4.61
(1.03)
5.12
(1.39)
4.66
(.85)
28. Secondary Outcome
Title Gait Speed--PWD
Description The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Number at baseline and follow-up differ due to withdrawals, staff error, participant unwilling to complete and participant unable to complete.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 22 22 21 21
Mean (Standard Deviation) [seconds]
5.51
(1.71)
4.79
(.94)
5.12
(1.06)
4.77
(1.14)
29. Secondary Outcome
Title Gait Variability--PWD
Description Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Subject numbers differ due to equipment failure, subjects withdrawing, subject inability to complete task, or lost to follow up.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 21 22 23 23
Mean (Standard Deviation) [percentage of variability]
3.41
(1.57)
3.10
(1.68)
3.44
(1.27)
3.15
(1.07)
30. Secondary Outcome
Title Gait Variability--PWD
Description Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Subject numbers differ due to equipment failure, technical error, subjects withdrawing, subject inability to complete task, or subject unwilling to complete task.
Arm/Group Title Dance Group Non-group Dance Social Group No Contact
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
Measure Participants 21 21 20 22
Mean (Standard Deviation) [percentage of variability]
4.46
(2.88)
2.71
(.75)
3.45
(1.30)
4.06
(4.15)
31. Other Pre-specified Outcome
Title Body Mass Index (BMI)
Description a measure of body fat based on height and weight that applies to adult men and women--PWD only
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
32. Other Pre-specified Outcome
Title Blood Pressure
Description PWD only
Time Frame Baseline, Week12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
33. Other Pre-specified Outcome
Title Neuroticism-Extraversion-Openness Five-Factor Inventory (NEO-FFI)
Description A measure of five domains of personality (neuroticism, extraversion, openness, agreeableness, and conscientiousness). A higher score on any scale indicates stronger presence of that trait. PWD only
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
34. Other Pre-specified Outcome
Title White Matter Lesion Burden
Description The volume of white matter lesions is calculated using the Lesion Segmentation Toolbox. PWD only.
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
35. Other Pre-specified Outcome
Title Blood-based Stress Biomarkers (Covariate or Alternative Hypothesis)
Description Social engagement may change biomarkers of stress relevant for interpreting outcomes. These stress biomarkers include cortisol and allostatic load, a composite measure of blood-based biomarkers associated with chronically elevated stress. PWD only
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
36. Other Pre-specified Outcome
Title Caregiver Quality of Life With the 36-item Short-Form Health (SF-36)--Covariate or Alternative Hypothesis
Description The SF-36 consists of 36 questions assessing physical functioning, role functioning difficulties caused by physical problems, bodily pain, general health, vitality, social functioning, role functioning difficulties caused by emotional problems, and mental health. High scores are representative of a great health status and better outcomes, while low scores are representative of a poor health status.
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
37. Other Pre-specified Outcome
Title Caregiver Burden With Zarit Caregiver Burden Scale--Covariate or Alternative Hypothesis
Description The Zarit Caregiver Burden Scale is administered in interview form to the caregiver. It consists of 22 questions scored 0-4 with 0=Never, 1=Rarely, 2=Sometimes, 3=Quite Frequently, 4=Nearly Always. The total score range is 0-88 with 88 being the worst possible outcome. 0-20 represents little or no burden on the caregiver, 21-40 represents mild to moderate burden, 41-60 represents moderate to severe burden, and 61-88 represents severe burden.
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame Baseline through Week 12
Adverse Event Reporting Description Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
Arm/Group Title Dance Group--PWD Dance Group--Caregivers Non-group Dance--PWD Non-group Dance--Caregivers Social Group--PWD Social Group--Caregivers No Contact--PWD No Contact--Caregivers Never Randomized-- PWD Never Randomized--Caregiver
Arm/Group Description The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. Caregivers of the PWDs in the Dance Group--these participants are part of the dyad mentioned in the participant flow. The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. Caregivers of the Non-group Dance PWDs--these participants are part of the dyad mentioned in the participant flow. The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Caregivers of the Social Group PWDs--these participants are part of the dyad mentioned in the participant flow. A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like. Caregivers of the No Contact PWDs--these participants are part of the dyad mentioned in the participant flow. PWD who dropped out before randomization Caregivers of the PWDs who never randomized.
All Cause Mortality
Dance Group--PWD Dance Group--Caregivers Non-group Dance--PWD Non-group Dance--Caregivers Social Group--PWD Social Group--Caregivers No Contact--PWD No Contact--Caregivers Never Randomized-- PWD Never Randomized--Caregiver
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/24 (0%) 0/24 (0%) 0/25 (0%) 0/25 (0%) 0/27 (0%) 0/27 (0%) 0/25 (0%) 0/25 (0%) 1/3 (33.3%) 0/3 (0%)
Serious Adverse Events
Dance Group--PWD Dance Group--Caregivers Non-group Dance--PWD Non-group Dance--Caregivers Social Group--PWD Social Group--Caregivers No Contact--PWD No Contact--Caregivers Never Randomized-- PWD Never Randomized--Caregiver
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/24 (4.2%) 4/24 (16.7%) 0/25 (0%) 2/25 (8%) 2/27 (7.4%) 4/27 (14.8%) 4/25 (16%) 2/25 (8%) 3/3 (100%) 1/3 (33.3%)
Cardiac disorders
Heart attack 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 1/27 (3.7%) 1 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Acute congestive heart failure 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 1/27 (3.7%) 1 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Gastrointestinal disorders
Acute colitis 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/3 (0%) 0 0/3 (0%) 0
Emergency room visit due to difficulty swallowing 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Upper gastrointestinal bleed 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 1/27 (3.7%) 1 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
General disorders
Death (prior to randomization) 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0
Infections and infestations
Pain in hip due to sepsis 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Injury, poisoning and procedural complications
Fell walking across street and hit chest on sidewalk 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/3 (0%) 0 0/3 (0%) 0
Accidentally given dilaudid in hospital 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 1/27 (3.7%) 1 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Complications and infection from hernia surgery 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0
Musculoskeletal and connective tissue disorders
Elective full knee replacement 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Hit head falling backward getting out of bed 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Nervous system disorders
Numbness and lack of coordination in arm 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0
Psychiatric disorders
Admitted to hospital for suicidal ideation 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Reproductive system and breast disorders
Prostate cancer recurrence 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Respiratory, thoracic and mediastinal disorders
Emergency room visit for shortness of breath 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
New diagnosis of non-small cell lung cancer 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 1/27 (3.7%) 1 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Emergency room visit for chest discomfort 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 1/27 (3.7%) 1 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Respiratory failure due to COVID 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Vascular disorders
Elevated blood pressure 1/24 (4.2%) 1 0/24 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1
Other (Not Including Serious) Adverse Events
Dance Group--PWD Dance Group--Caregivers Non-group Dance--PWD Non-group Dance--Caregivers Social Group--PWD Social Group--Caregivers No Contact--PWD No Contact--Caregivers Never Randomized-- PWD Never Randomized--Caregiver
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 15/24 (62.5%) 13/24 (54.2%) 15/25 (60%) 5/25 (20%) 11/27 (40.7%) 8/27 (29.6%) 17/25 (68%) 15/25 (60%) 0/3 (0%) 0/3 (0%)
Blood and lymphatic system disorders
Low hemoglobin 0/24 (0%) 0 0/24 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Abnormal lab results 0/24 (0%) 0 2/24 (8.3%) 3 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/3 (0%) 0 0/3 (0%) 0
Cardiac disorders
Chest pain and dizziness 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Ear and labyrinth disorders
Swimmer's ear 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 1/27 (3.7%) 1 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Eye disorders
Eye surgery 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Gastrointestinal disorders
Chest pain due to gastrointestinal issue 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Diverticulitis flare 0/24 (0%) 0 0/24 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Acute gastritis 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Diarrhea and cough 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
General disorders
Exhaustion spell 0/24 (0%) 0 0/24 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Headache 1/24 (4.2%) 1 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Incidental finding on MRI-space occupying lesion 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 1/27 (3.7%) 1 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Seen by surgeon for hernia surgery-no treatment 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Admitted to rehabilitation center 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 1/27 (3.7%) 1 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Infections and infestations
Cellulitis 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/3 (0%) 0 0/3 (0%) 0
Acute cystitis 1/24 (4.2%) 1 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Sinus infection 0/24 (0%) 0 0/24 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Infection in finger 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 1/27 (3.7%) 1 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Injury, poisoning and procedural complications
Motor vehicle accident 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 2/25 (8%) 2 0/3 (0%) 0 0/3 (0%) 0
Slipped on wet pavement 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Musculoskeletal and connective tissue disorders
Sprained foot after fall (unrelated to study) 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Shoulder pain from arthritis 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 1/25 (4%) 1 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Fall outside of study, no treatment needed 5/24 (20.8%) 6 1/24 (4.2%) 1 5/25 (20%) 6 0/25 (0%) 0 4/27 (14.8%) 5 4/27 (14.8%) 5 5/25 (20%) 5 5/25 (20%) 5 0/3 (0%) 0 0/3 (0%) 0
Fall during data collection visit, no treatment needed 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Stumbled at home 1/24 (4.2%) 1 0/24 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 1/27 (3.7%) 1 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Leg pain 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/3 (0%) 0 0/3 (0%) 0
Pulled muscle in lower back 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Knee pain 1/24 (4.2%) 1 1/24 (4.2%) 1 2/25 (8%) 2 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/3 (0%) 0 0/3 (0%) 0
Knee and hip pain 0/24 (0%) 0 0/24 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Back pain 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 1/27 (3.7%) 1 1/27 (3.7%) 1 1/25 (4%) 1 1/25 (4%) 1 0/3 (0%) 0 0/3 (0%) 0
Foot pain 2/24 (8.3%) 2 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Toothache, swollen jaw 0/24 (0%) 0 0/24 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Hip pain during intervention 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Leg cramps 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Broken ankle 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Knee arthroscopy 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/3 (0%) 0 0/3 (0%) 0
Ruptured patellar tendon 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Tooth implants 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 1/27 (3.7%) 1 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Bilateral recurrent inguinal hernia repair 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 1/27 (3.7%) 1 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Nervous system disorders
Shingles 1/24 (4.2%) 1 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Product Issues
Discontinued atorvastatin 1/24 (4.2%) 1 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Side effects from donepezil 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 1/27 (3.7%) 1 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Renal and urinary disorders
Urinary tract infection 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Laser cytoscopy for bladder stones 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 1/27 (3.7%) 1 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Respiratory, thoracic and mediastinal disorders
Respiratory infection 1/24 (4.2%) 1 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Recurrent pneumonia 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Labored breathing and chest pain when bending over 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/3 (0%) 0 0/3 (0%) 0
Skin and subcutaneous tissue disorders
Basal cell carcinoma removed from arm 1/24 (4.2%) 1 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Surgical and medical procedures
Aspiration of thyroid nodule 0/24 (0%) 0 1/24 (4.2%) 1 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Injections for knee pain 0/24 (0%) 0 0/24 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0
Dermatology treatment 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 0/25 (0%) 0 1/25 (4%) 1 0/3 (0%) 0 0/3 (0%) 0
Removal of squamous cell carcinoma 0/24 (0%) 0 0/24 (0%) 0 0/25 (0%) 0 0/25 (0%) 0 0/27 (0%) 0 0/27 (0%) 0 1/25 (4%) 1 0/25 (0%) 0 0/3 (0%) 0 0/3 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Christina Hugenschmidt, PhD
Organization Wake Forest University School of Medicine
Phone 336-713-8116
Email chugensc@wakehealth.edu
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT03333837
Other Study ID Numbers:
  • IRB00042460
  • R01AT009444
First Posted:
Nov 7, 2017
Last Update Posted:
Jul 27, 2022
Last Verified:
May 1, 2022