Activate For Life: mHealth Intervention To Address Pain And Fatigue In Low-income Older Adults Aging In Place

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT03853148

Collaborator

National Institutes of Health (NIH) (NIH), National Institute of Nursing Research (NINR) (NIH)

Enrollment

Location

Arms

39.6

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Overall Aim of the present proposal is to evaluate the feasibility of an integrated mind-body intervention, Activate for Life, to improve overall physical activity and mental health and reduce pain and fatigue, resulting in increased likelihood of Aging in Place. Both subjective self-report (i.e., Patient-Reported Outcomes Measurement Information System PROMIS measures of pain, fatigue, depression and anxiety) and objective accelerometer data will be collected, along with standardized measures of balance, strength, and stability. In addition, the measures will be complemented with biomarker-based measures of stress, including cortisol based and 1,5-AG anhydroglucitol assays before, during, and after treatment that are correlated with stress, and fatigue symptoms.

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic Fatigue Syndrome, Chronic Aging	Behavioral: Otago Behavioral: Gentle yogic breathing Behavioral: Behavioral Activation Behavioral: Caregiver Gentle yogic breathing	N/A

Detailed Description

The goal of supplement study is to test the feasibility of a self-managed (SM), electronic/mobile Health (e/mHealth) yoga intervention for reducing stress symptoms (burden) in older caregivers (CG) of people with Alzheimer's Disease and related dementia's (PWD). CG burden can exacerbate a myriad of physical and psychosocial comorbidities in CGs as well as PWD neuropsychiatric symptoms. These effects may be further amplified in older CG with underlying health concerns or those who are not able to access programs for effective management of their own medical or self-care needs. Low-impact physical activities such as gentle Yoga (GY) have shown positive effects on mood and symptoms of pain and fatigue in older community dwellers, and digital e/mHealth platforms have a great deal of potential to overcome financial and medical barriers for the delivery SM stress interventions across demographic boundaries. In this study, we will examine the feasibility of a 12-week e/mHealth gentle yoga+yogic breathing (GYYB) intervention for alleviating symptoms of burden in aging CG of PWD (Aim 1); measure initial changes in stress and QoL indicators in CG and PWD (post- vs. pre-intervention) to inform an adequately-powered, future efficacy trial (Aim 2), and; establish a Dyadic Analysis Training Program for Medical University of South Carolina (MUSC) faculty within the College of Nursing and P20 Symptom Self-Management Center (SSMC) to support future research evaluating the influence of care-recipient interactions on health outcomes (Aim 3). Feasibility will be assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, and will include measures such as recruitment, adherence, treatment satisfaction, attrition, and feedback for intervention refinement. Data related to CG physical function, fatigue, depression, social isolation, loneliness, relationship quality, burden, and stress biomarkers, as well as PWD and CG QoL, will be collected via daily electronic practice logs and interviews at study beginning and end. Older (45 yrs. old and older) male and female CG (N=20) of PWD regularly attending respite care (RCC) programs will be recruited from an existing study population (R01 NR016466) participating in CG-RCC mealtime partnerships for improved PWD nutritional outcomes. The HIPAA-compliant GYYB intervention will employ 'tablets' that allow CG to practice GYYB at home by following along with recorded lessons. CG will initially be trained on the use of the tablet and proper GYYB practices by the study coordinator (in-home), with weekly follow up (videoconference/phone) for the duration of the study. This investigation is ideally aligned with the aims of the parent SSMC (P20 NR016575) that are focused on providing infrastructure and community-based resources for design and ecologically-valid testing of self management (SM) interventions for individuals with chronic conditions.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Activate For Life: A Nurse Delivered Hybrid Telehealth/mHealth Aging In Place Intervention To Address Pain And Fatigue In Low-income Older Adults

Actual Study Start Date :

Feb 6, 2019

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

May 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Otago The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level.	Behavioral: Otago Exercise program for strength and balance
Active Comparator: Otago + Gentle yogic breathing The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits.	Behavioral: Otago Exercise program for strength and balance Behavioral: Gentle yogic breathing yogic breathing Other Names: GYYB
Active Comparator: Otago + GYYB + Behavioral activation This condition will incorporate Otago and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days.	Behavioral: Otago Exercise program for strength and balance Behavioral: Gentle yogic breathing yogic breathing Other Names: GYYB Behavioral: Behavioral Activation Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.
Experimental: Caregiver Gentle yoga & yogic breathing The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits.	Behavioral: Caregiver Gentle yogic breathing yogic breathing Other Names: Caregiver GYYB

Outcome Measures

Primary Outcome Measures

Older Adult Pain Intensity [Baseline to 12 weeks]
Change in mean pain T-scores as measured with the Patient-Reported Outcomes Measurement Information System PROMIS Pain Intensity short form 3a, which allows for individuals to report how much a person hurts. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the more pain interferes with aspects of one's life compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe pain intensity.
Older Adult Fatigue [Baseline to 12 weeks]
Change in mean fatigue T-score as measured by PROMIS Fatigue short form 6a, 6 items that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse the fatigue the individual has compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe fatigue.
Older Adult Pain Behavior [Baseline to 12 weeks]
Change in mean pain T-score as measured with PROMIS Pain Behavior short form 7a, which allows for self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain. These actions or reactions can be verbal or nonverbal, and involuntary or deliberate. The lowest possible raw score is 7; the highest possible raw score is 42. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse or more pain behavior the individual has compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe pain behavior.

Secondary Outcome Measures

Older Adult Functional Status [Baseline to 12 weeks]
Change in mean functional T-score as measured by PROMIS Physical Function 10b, 10-item instrument that assesses sit-to-stand, walking, and balance abilities as well as self-reported physical abilities including mobility, upper and lower extremity strength, core strength, and activities of daily living. The lowest possible raw score is 10; the highest possible raw score is 50. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the lower scores below 10 indicate a greater degree of impaired function. Scores >55 within normal limits, 56-40 mild, 41-30 moderate, <30 severe (worse functional status).
Older Adult Balance [Baseline to 12 weeks]
Change in mean balance scores measured with the Berg Balance Scale, which includes 14 tests (e.g., standing on one leg, stepping over obstacles). Each task is worth 0-2 points and points are summed for a total score. Higher scores indicate better balance and lower scores indicate fall risk. Scores range from 0 - 56. 1 - 20 indicates a person will likely need assistance of a wheelchair to move around safety due to major limitations/poor balance noted during the assessment of the tasks; 21 - 40 indicates a person will need some type of walking assistance such as a cane or walker due to problems or limitations with some of the movement on the scale; 41 - 56 indicates a person is considered independent and able to move around safely without assistance and is at low risk for falling.
Older Adult Sit-to-Stand Capability [Baseline to 12 weeks]
Change in mean number of times an individual comes to a full standing position from the seated position when 30 seconds have elapsed measured with the 30-Second (s) Chair Test to assess lower body strength. Higher numbers indicate better lower body strength. Below average sit-to-stand scores per age groups are as follows: men 60-64 <14, women < 12; men 65-69 <12, women <11; men 70-74 <12; women <10; men 75-79 <11, women <10; men 81-84 <10, women <9; men 85-89 <8, women <8; men 90-94 <7, women <4. Unfortunately we were unable to collect these data due to COVID restrictions. We were unable to make home visits or have participants come into our research clinic to assess their sit-to-stand ability because we were not permitted to have patient contact.
Older Adult Walking Ability [Baseline to 12 weeks]
Change in mean walking distance in feet over a timed two-minute period measured with the Two-Minute Walk Test to assess walking ability.
Older Adult Depression [Baseline to 12 weeks]
Change in mean depression T-score measured with the Patient-Reported Outcomes Measurement Information System PROMIS Depression short form 8a, 8 individual items allow for different responses which are scored separately to provide specific information about self-reported negative mood (sadness, guilt), view of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). The lowest possible raw score is 8; the highest possible raw score is 40. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 suggests an individual has greater depressive symptoms compared to the general population.
Older Adult Self Efficacy [Baseline to 12 weeks]
Change in mean self efficacy score measured with the Common Data Repository For Nursing Science (cdRNS) National Institute of Nursing Research, Self-Efficacy for Managing Chronic Disease questionnaire which contains 6-items that cover several domains that are common across many chronic diseases including symptom control, role function, emotional functioning and communicating with physicians. Scores range from 1 (not at all confident) to 10 (totally confident). A sum score is reported. Higher score indicate higher self efficacy or confidence in managing one's disease.
Older Adult Daily Steps [Baseline to 12 weeks]
Steps were measured with an actigraph and reported as mean numbers of steps taken per week during the 12-week study period. The mean number of steps per week for the participants who completed the study in each arm is reported for the 12-week final study measurement period. Full range of steps taken is reported indicating minimum and maximum steps taken at the end of study 12-week period for the participants who completed all 12 weeks of the study.
Caregiver Anxiety [Baseline to 12 weeks]
Change in mean anxiety status T-score measured with PROMIS Anxiety short form 6a, 6 individual items allow for different responses which are scored separately to provide specific information about self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 suggests an individual has greater anxiety symptoms compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe anxiety.
Caregiver Health Status [Baseline to 12 weeks]
Change in mean health status score measured with PROMIS Global Health Scale, 10 individual items allow for different responses which are scored separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the better or more healthy the individual is compared to the general population. Scores 20-35 = poor, 36-42 fair, 43-50 good, 51-57 very good, >58 excellent health status.
Caregiver Functional Health [Baseline to 12 weeks]
Change in mean functional health T-score measured with PROMIS Physical Function Scale short form 8b, 8 individual items allow for different responses which are scored separately to provide specific information about self-reported current capability rather than actual performance of physical activities. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the better function the individual has compared to the general population. Scores >55 within normal limits, 56-40 mild, 41-30 moderate, <30 severe physical functional impairment (worse health).
Caregiver Sleep Disturbance [Baseline to 12 weeks]
Change in mean sleep disturbance score measured with PROMIS Sleep Disturbance short form 6a, 6 individual items allow for different responses which are scored separately to provide specific information about self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse or the greater the individual's sleep is disturbed compared to individuals with chronic conditions. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe sleep disturbance.
Caregiver Depression [Baseline to 12 weeks]
Change in mean depression score measured with PROMIS Depression short form 8a, 8 individual items allow for different responses which are scored separately to provide specific information about self-reported negative mood (sadness, guilt), view of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). The lowest possible raw score is 8; the highest possible raw score is 40. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 suggests an individual has greater depressive symptoms compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe depression.
Caregiver Depression CES-D [Baseline to 12 weeks]
Change in mean depression score measured with the Center for Epidemiological Studies-Depression scale (CES-D), 20 items - that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The cutoff scores (e.g., 16 or greater) identify individuals at risk for clinical depression.
Caregiver Fatigue [Baseline to 12 weeks]
Change in mean fatigue score measured with the PROMIS Fatigue short form 6a, 6 items that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse the fatigue the individual has compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe fatigue].
Caregiver Loneliness [Baseline to 12 weeks]
Change in mean loneliness score measured with the University of California Los Angeles UCLA Loneliness Scale which contains 20 items designed to measure one's subjective feelings of loneliness and social isolation. Participants rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"): O's = 3, all S's = 2, all R's = 1, and all N's = 0. Higher scores indicate higher loneliness. Cut-off score of 20 or > indicates loneliness.
Caregiver Social Support [12 weeks]
Change in mean social support scores measured with the Medical Outcomes Study Social Support Survey Instrument (MOS-SS) contains 19 items with four separate social support subscales and an overall functional social support index. To obtain a score for each subscale, calculate the average of the scores for each item in the subscale. To obtain an overall support index, the average of (1) the scores for all 18 items included in the four subscales, and (2) the score for the one additional item (see last item in the survey) is calculated. Scale scores are transformed to a 0-100 scale and compared to published means reported in Sherbourne, C.D., and Stewart, A.L., "The MOS Social Support Survey,"Social Science and Medicine, 32(6):705-714, 1991. A higher score for an individual scale or for the overall support index indicates more support. Scores suggest poor,(less than 60) fair (60-79) and good social support (more than 80).
Caregiver Burden [Baseline to 12 weeks]
Change in mean caregiver burden measured with Zarit Burden Scale (ZBI-12) - 12 items provide a summation score: (0 to 4 points per item, total score range 0 to 48). 0 - 10: no to mild burden; 11 - 20: mild to moderate burden; > 20 high burden.
Caregiver Quality of Life (QOL) [Baseline to 12 weeks]
Change in mean quality of life (QOL) scores measured with the European Quality of Life Five Dimensions (EQ-5D) compromises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and how good/bad one's health with visual analog scale (VAS)) from 0 worst to 100 best health you can imagine) and divided into 3 levels of perceived problems. An EQ-5D summary index is derived by applying a formula that attaches values/weights to each level per dimension. The index is calculated by deducting the appropriate weights from 1, the value for full health and presented as an averaged score. Higher values (scores of 3) indicate extreme pain, depression/anxiety, inability to perform usual activities, unable to wash or dress self, or confined to bed. High VAS scores indicate good perceived health. There are no established/published cut-off scores/values to determine excellent, good, fair or poor QOL levels. Population means are ~70, higher values indicate higher QOL.
Caregiver Relationship Quality [Baseline to 12 weeks]
Change in mean relationship quality score measured with the Mutuality Scale, a 15-item instrument that measures mutuality (love, shared pleasurable activities, shared values, and reciprocity) from the caregiver perspective. Examples of items are: "How close do you feel to the person you care for?" or "How much do you confide in the person you care for?". Each item is scored on a 5-point Likert-type scale from 0 (not at all), 1 (a little), 2 (some), 3 (quite a bit) to 4 (a great deal). The total scale score, a mean of all item scores, ranges from 0 to 4 (total 0 - 60): higher scores means greater mutuality. There are no established cut-off scores or ranges and are reported in means: 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, 4 = a great deal.
Person With Dementia Quality of Life [Baseline to 12 weeks]
Change in mean quality of life score measured with the Life-Alzheimer's Disease (QOL-AD), a 13-item questionnaire designed to be administered via interview to persons with dementia (if able to answer) or by a caregiver. 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 items. Higher scores indicated higher quality of life. Maximum score is 52. There is no cut-off scores or values/ranges for excellent, good, fair or poor QOL.
Person With Dementia Activities of Daily Living [Baseline to 12 weeks]
Change in mean score on functional activities of daily living measured with the Activities of Daily Living (ADL) Questionnaire which is completed by the caregiver and consists of 46 items for 3 domains: initiation, planning and organization, and performance. The total score, has a range of 0 to 100. The denominator represents the score that would have been obtained if the most severe level of impairment had been indicated for all items rated (excluding those rated ''9''). The numerator represents the total of the actual ratings for all items rated (excluding those rated ''9''). The resultant score represents the level of severity of impairment in ADL. The amount of functional impairment is then rated as ''none to mild'' (0-33),''moderate'' (34-66%), or ''severe'' (.66%). Functional impairment scores are calculated for each subscale individually and for the total of all items. We reported the difference in the total score from baseline to 12-week end of study.
Caregiver of Persons With Dementia Physical Activity [Baseline to 12 weeks]
Change in mean minutes (mean difference between baseline and 12 weeks end of study) during the last 7 days engaged in physical activity measured with the International Physical Activity Questionnaire for the Elderly (IPAQ-Short Form) which is comprised of 4 items (sitting, walking, moderate physical activity, vigorous physical activity). For full range (-) indicates fewer mean minutes taken between baseline and 12 weeks.
Salivary Cortisol [Baseline to 12 weeks]
Change in mean laboratory value of cortisol which is an indicator of the hypothalamus-pituitary-adrenal (HPA) axis activity which represents the dominance of the sympathetic nervous system, a measure of psychosomatic stress level. Cortisol reference values are: 3.7-9.5 ng/mL (morning), 1.2-3.0 ng/mL (noon), 0.6-1.9 ng/mL (evening), 0.4-1.0 ng/mL (bedtime). Higher values have been associated with higher stress.
Salivary 1,5-Anhydroglucitol (AG) [Baseline to 12 weeks]
Change in mean laboratory values of 1,5-Anhydroglucitol (AG) which is a biomarker for glycemic metabolism and is reduced under stressful circumstances. The normal reference value for 1,5 AG is ≥ 14.0 μg/ml.
Adherence [End of study at 12 weeks post intervention]
Using study data logs, appropriate use of the interventions was measured by the number of participants who adhered to the protocol for engaging in Arm 1 Otago, Arm 2 Otago + Gentle yoga/yogic breathing, Arm 3 behavioral activation (Older adults) or Arm 4 Gentle yoga/yogic breathing (Caregivers). Adherence was defined as the number of participants (rounded up) who completed the study and were at least 80% adherent to the study protocol for frequency of engaging in the assigned Arm during the 12-week study period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion and Exclusion Criteria for Older Adults (Arms 1, 2, 3):

Males and females older adults 60 years of age and older living in a Humanities Foundation apartment complex or in their own homes
PROMIS pain interference score of eight or above and/or a PROMIS pain behavior score of 15 or above (for older adults)
Able to ambulate 150 feet with or without the use of an assistive device
Able to follow simple instructions
Able to read, speak, and write English,
Able to operate tablet device and wearable activity tracker,
Not currently enrolled in an exercise program.

Exclusion Criteria:

Inability or unwillingness of participant to give informed consent,
Physical, cognitive, sensory or psychiatric disability that would limit participants from engaging in self-management program as noted by a Mini-Cog score of 0-2.
Unwillingness to wear a physical activity tracker during the course of the study.

Inclusion and Exclusion Criteria for Caregivers (Arm 4)

CG must be able to speak and read English
CG must be 45 years of age or older
CG must be able to provide consent for himself or herself
CG must live with or on same property as the PWD
CG be primarily responsible for care provision of the PWD in the home (i.e., is not paid for services; provides 4 hours or more of care/day; assists with activities of daily living-ADLs)

Exclusion Criteria:

CG for whom yoga techniques would be detrimental due to physical limitations,
CG who are enrolled in other Yoga-related clinical trials, or who are currently engaged in regular Yoga activity once per week or more.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	College of Nursing Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Teresa Kelechi, Professor, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT03853148

Other Study ID Numbers:

Pr00076835
5P20NR016575-05

First Posted:

Feb 25, 2019

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatigue Syndrome, Chronic

Fatigue

Chronic Pain

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Period Title: Overall Study
STARTED	10	10	10	20
COMPLETED	5	2	2	15
NOT COMPLETED	5	8	8	5

Baseline Characteristics

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing	Total
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing	Total of all reporting groups
Overall Participants	10	10	10	20	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	3 30%	2 20%	8 40%	13 26%
>=65 years	10 100%	7 70%	8 80%	12 60%	37 74%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	73.4 (5.6)	68.5 (7.5)	69.8 (5.4)	68.7 (8.0)	70.1 (6.6)
Sex: Female, Male (Count of Participants)
Female	7 70%	7 70%	7 70%	14 70%	35 70%
Male	3 30%	3 30%	3 30%	6 30%	15 30%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	10 100%	10 100%	10 100%	20 100%	50 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	5 50%	5 50%	8 80%	2 10%	20 40%
White	5 50%	5 50%	2 20%	18 90%	30 60%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	10 100%	20 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Older Adult Pain Intensity
Description	Change in mean pain T-scores as measured with the Patient-Reported Outcomes Measurement Information System PROMIS Pain Intensity short form 3a, which allows for individuals to report how much a person hurts. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the more pain interferes with aspects of one's life compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe pain intensity.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This questionnaire was given to the older adults only, not the caregivers.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	8	6	4	0
Mean (Standard Deviation) [T-score]	-3.25 (0.3)	-2.8 (4.2)	-0.5 (1.6)

2. Primary Outcome

Title	Older Adult Fatigue
Description	Change in mean fatigue T-score as measured by PROMIS Fatigue short form 6a, 6 items that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse the fatigue the individual has compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe fatigue.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This questionnaire was given to the older adults only, not the caregivers.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	8	5	5	0
Mean (Standard Deviation) [T-score]	0.9 (1.5)	-0.8 (7.6)	-4.0 (1.9)

3. Primary Outcome

Title	Older Adult Pain Behavior
Description	Change in mean pain T-score as measured with PROMIS Pain Behavior short form 7a, which allows for self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain. These actions or reactions can be verbal or nonverbal, and involuntary or deliberate. The lowest possible raw score is 7; the highest possible raw score is 42. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse or more pain behavior the individual has compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe pain behavior.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This questionnaire was given to the older adults only, not the caregivers.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	7	6	4	0
Mean (Standard Deviation) [T-score]	-0.7 (1.2)	2.2 (6.1)	-3.7 (1.7)

4. Secondary Outcome

Title	Older Adult Functional Status
Description	Change in mean functional T-score as measured by PROMIS Physical Function 10b, 10-item instrument that assesses sit-to-stand, walking, and balance abilities as well as self-reported physical abilities including mobility, upper and lower extremity strength, core strength, and activities of daily living. The lowest possible raw score is 10; the highest possible raw score is 50. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the lower scores below 10 indicate a greater degree of impaired function. Scores >55 within normal limits, 56-40 mild, 41-30 moderate, <30 severe (worse functional status).
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This questionnaire was completed by both older adults and caregivers.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	7	5	4	15
Mean (Standard Deviation) [T-score]	1.0 (4)	3.1 (1.5)	1.5 (2.1)	1.7 (0.8)

5. Secondary Outcome

Title	Older Adult Balance
Description	Change in mean balance scores measured with the Berg Balance Scale, which includes 14 tests (e.g., standing on one leg, stepping over obstacles). Each task is worth 0-2 points and points are summed for a total score. Higher scores indicate better balance and lower scores indicate fall risk. Scores range from 0 - 56. 1 - 20 indicates a person will likely need assistance of a wheelchair to move around safety due to major limitations/poor balance noted during the assessment of the tasks; 21 - 40 indicates a person will need some type of walking assistance such as a cane or walker due to problems or limitations with some of the movement on the scale; 41 - 56 indicates a person is considered independent and able to move around safely without assistance and is at low risk for falling.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This questionnaire was given to the older adults only, not the caregivers.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	6	2	2	0
Mean (Standard Deviation) [Score on a scale]	-1.8 (1.1)	-4.5 (0.7)	-4.5 (0.3)

6. Secondary Outcome

Title	Older Adult Sit-to-Stand Capability
Description	Change in mean number of times an individual comes to a full standing position from the seated position when 30 seconds have elapsed measured with the 30-Second (s) Chair Test to assess lower body strength. Higher numbers indicate better lower body strength. Below average sit-to-stand scores per age groups are as follows: men 60-64 <14, women < 12; men 65-69 <12, women <11; men 70-74 <12; women <10; men 75-79 <11, women <10; men 81-84 <10, women <9; men 85-89 <8, women <8; men 90-94 <7, women <4. Unfortunately we were unable to collect these data due to COVID restrictions. We were unable to make home visits or have participants come into our research clinic to assess their sit-to-stand ability because we were not permitted to have patient contact.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
We were unable to collect these data due to coronavirus disease of 2019 (COVID-19) restrictions. We were unable to make home visits or have participants come into our research clinic to assess their sit-to-stand ability because we were not permitted to have patient contact.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	0

7. Secondary Outcome

Title	Older Adult Walking Ability
Description	Change in mean walking distance in feet over a timed two-minute period measured with the Two-Minute Walk Test to assess walking ability.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This questionnaire was given to the older adults only, not the caregivers.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	7	5	4	0
Mean (Standard Deviation) [Feet]	17.4 (17.1)	-6.8 (3)	24 (15.8)

8. Secondary Outcome

Title	Older Adult Depression
Description	Change in mean depression T-score measured with the Patient-Reported Outcomes Measurement Information System PROMIS Depression short form 8a, 8 individual items allow for different responses which are scored separately to provide specific information about self-reported negative mood (sadness, guilt), view of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). The lowest possible raw score is 8; the highest possible raw score is 40. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 suggests an individual has greater depressive symptoms compared to the general population.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This questionnaire was given to the older adults only, not the caregivers.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	8	6	5	0
Mean (Standard Deviation) [T-score]	-1.57 (0.52)	0.37 (0.36)	-5.26 (2.06)

9. Secondary Outcome

Title	Older Adult Self Efficacy
Description	Change in mean self efficacy score measured with the Common Data Repository For Nursing Science (cdRNS) National Institute of Nursing Research, Self-Efficacy for Managing Chronic Disease questionnaire which contains 6-items that cover several domains that are common across many chronic diseases including symptom control, role function, emotional functioning and communicating with physicians. Scores range from 1 (not at all confident) to 10 (totally confident). A sum score is reported. Higher score indicate higher self efficacy or confidence in managing one's disease.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This questionnaire was given to the older adults only, not the caregivers.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	8	6	5	0
Mean (Standard Deviation) [Score on a scale]	-0.39 (0.95)	0.06 (0.59)	-0.31 (0.32)

10. Secondary Outcome

Title	Older Adult Daily Steps
Description	Steps were measured with an actigraph and reported as mean numbers of steps taken per week during the 12-week study period. The mean number of steps per week for the participants who completed the study in each arm is reported for the 12-week final study measurement period. Full range of steps taken is reported indicating minimum and maximum steps taken at the end of study 12-week period for the participants who completed all 12 weeks of the study.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
Steps taken were only measured in older adults only, not the caregivers.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	5	3	4	0
Mean (Full Range) [Steps walked]	32201	29577	24699

11. Secondary Outcome

Title	Caregiver Anxiety
Description	Change in mean anxiety status T-score measured with PROMIS Anxiety short form 6a, 6 individual items allow for different responses which are scored separately to provide specific information about self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 suggests an individual has greater anxiety symptoms compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe anxiety.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
Anxiety was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [T-score]	1.7

12. Secondary Outcome

Title	Caregiver Health Status
Description	Change in mean health status score measured with PROMIS Global Health Scale, 10 individual items allow for different responses which are scored separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the better or more healthy the individual is compared to the general population. Scores 20-35 = poor, 36-42 fair, 43-50 good, 51-57 very good, >58 excellent health status.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [T-score]	1.2

13. Secondary Outcome

Title	Caregiver Functional Health
Description	Change in mean functional health T-score measured with PROMIS Physical Function Scale short form 8b, 8 individual items allow for different responses which are scored separately to provide specific information about self-reported current capability rather than actual performance of physical activities. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the better function the individual has compared to the general population. Scores >55 within normal limits, 56-40 mild, 41-30 moderate, <30 severe physical functional impairment (worse health).
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [T-score]	1.7

14. Secondary Outcome

Title	Caregiver Sleep Disturbance
Description	Change in mean sleep disturbance score measured with PROMIS Sleep Disturbance short form 6a, 6 individual items allow for different responses which are scored separately to provide specific information about self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse or the greater the individual's sleep is disturbed compared to individuals with chronic conditions. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe sleep disturbance.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [T-score]	-0.6

15. Secondary Outcome

Title	Caregiver Depression
Description	Change in mean depression score measured with PROMIS Depression short form 8a, 8 individual items allow for different responses which are scored separately to provide specific information about self-reported negative mood (sadness, guilt), view of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). The lowest possible raw score is 8; the highest possible raw score is 40. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 suggests an individual has greater depressive symptoms compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe depression.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [T-score]	-0.8

16. Secondary Outcome

Title	Caregiver Depression CES-D
Description	Change in mean depression score measured with the Center for Epidemiological Studies-Depression scale (CES-D), 20 items - that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The cutoff scores (e.g., 16 or greater) identify individuals at risk for clinical depression.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [Score on a scale]	-0.3

17. Secondary Outcome

Title	Caregiver Fatigue
Description	Change in mean fatigue score measured with the PROMIS Fatigue short form 6a, 6 items that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse the fatigue the individual has compared to the general population. Scores <55 within normal limits, 55-60 mild, 61-70 moderate, >70 severe fatigue].
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [T-score]	-4.7

18. Secondary Outcome

Title	Caregiver Loneliness
Description	Change in mean loneliness score measured with the University of California Los Angeles UCLA Loneliness Scale which contains 20 items designed to measure one's subjective feelings of loneliness and social isolation. Participants rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"): O's = 3, all S's = 2, all R's = 1, and all N's = 0. Higher scores indicate higher loneliness. Cut-off score of 20 or > indicates loneliness.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [Score on a scale]	-0.9

19. Secondary Outcome

Title	Caregiver Social Support
Description	Change in mean social support scores measured with the Medical Outcomes Study Social Support Survey Instrument (MOS-SS) contains 19 items with four separate social support subscales and an overall functional social support index. To obtain a score for each subscale, calculate the average of the scores for each item in the subscale. To obtain an overall support index, the average of (1) the scores for all 18 items included in the four subscales, and (2) the score for the one additional item (see last item in the survey) is calculated. Scale scores are transformed to a 0-100 scale and compared to published means reported in Sherbourne, C.D., and Stewart, A.L., "The MOS Social Support Survey,"Social Science and Medicine, 32(6):705-714, 1991. A higher score for an individual scale or for the overall support index indicates more support. Scores suggest poor,(less than 60) fair (60-79) and good social support (more than 80).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [Score on a scale]	1.4

20. Secondary Outcome

Title	Caregiver Burden
Description	Change in mean caregiver burden measured with Zarit Burden Scale (ZBI-12) - 12 items provide a summation score: (0 to 4 points per item, total score range 0 to 48). 0 - 10: no to mild burden; 11 - 20: mild to moderate burden; > 20 high burden.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [Score on a scale]	3.4

21. Secondary Outcome

Title	Caregiver Quality of Life (QOL)
Description	Change in mean quality of life (QOL) scores measured with the European Quality of Life Five Dimensions (EQ-5D) compromises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and how good/bad one's health with visual analog scale (VAS)) from 0 worst to 100 best health you can imagine) and divided into 3 levels of perceived problems. An EQ-5D summary index is derived by applying a formula that attaches values/weights to each level per dimension. The index is calculated by deducting the appropriate weights from 1, the value for full health and presented as an averaged score. Higher values (scores of 3) indicate extreme pain, depression/anxiety, inability to perform usual activities, unable to wash or dress self, or confined to bed. High VAS scores indicate good perceived health. There are no established/published cut-off scores/values to determine excellent, good, fair or poor QOL levels. Population means are ~70, higher values indicate higher QOL.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [Score on a scale]	-6.3

22. Secondary Outcome

Title	Caregiver Relationship Quality
Description	Change in mean relationship quality score measured with the Mutuality Scale, a 15-item instrument that measures mutuality (love, shared pleasurable activities, shared values, and reciprocity) from the caregiver perspective. Examples of items are: "How close do you feel to the person you care for?" or "How much do you confide in the person you care for?". Each item is scored on a 5-point Likert-type scale from 0 (not at all), 1 (a little), 2 (some), 3 (quite a bit) to 4 (a great deal). The total scale score, a mean of all item scores, ranges from 0 to 4 (total 0 - 60): higher scores means greater mutuality. There are no established cut-off scores or ranges and are reported in means: 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, 4 = a great deal.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [Score on a scale]	0.2

23. Secondary Outcome

Title	Person With Dementia Quality of Life
Description	Change in mean quality of life score measured with the Life-Alzheimer's Disease (QOL-AD), a 13-item questionnaire designed to be administered via interview to persons with dementia (if able to answer) or by a caregiver. 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 items. Higher scores indicated higher quality of life. Maximum score is 52. There is no cut-off scores or values/ranges for excellent, good, fair or poor QOL.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
Persons with Alzheimer's Disease and Related Dementias, not caregivers or older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [Score on a scale]	1.9

24. Secondary Outcome

Title	Person With Dementia Activities of Daily Living
Description	Change in mean score on functional activities of daily living measured with the Activities of Daily Living (ADL) Questionnaire which is completed by the caregiver and consists of 46 items for 3 domains: initiation, planning and organization, and performance. The total score, has a range of 0 to 100. The denominator represents the score that would have been obtained if the most severe level of impairment had been indicated for all items rated (excluding those rated ''9''). The numerator represents the total of the actual ratings for all items rated (excluding those rated ''9''). The resultant score represents the level of severity of impairment in ADL. The amount of functional impairment is then rated as ''none to mild'' (0-33),''moderate'' (34-66%), or ''severe'' (.66%). Functional impairment scores are calculated for each subscale individually and for the total of all items. We reported the difference in the total score from baseline to 12-week end of study.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
Persons with Alzheimer's Disease and Related Dementias

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (95% Confidence Interval) [Score on a scale]	1.0

25. Secondary Outcome

Title	Caregiver of Persons With Dementia Physical Activity
Description	Change in mean minutes (mean difference between baseline and 12 weeks end of study) during the last 7 days engaged in physical activity measured with the International Physical Activity Questionnaire for the Elderly (IPAQ-Short Form) which is comprised of 4 items (sitting, walking, moderate physical activity, vigorous physical activity). For full range (-) indicates fewer mean minutes taken between baseline and 12 weeks.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in Caregivers of Persons with Alzheimer's Disease and Related Dementias, not older adults.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	0	0	0	15
Mean (Full Range) [Minutes]	213

26. Secondary Outcome

Title	Salivary Cortisol
Description	Change in mean laboratory value of cortisol which is an indicator of the hypothalamus-pituitary-adrenal (HPA) axis activity which represents the dominance of the sympathetic nervous system, a measure of psychosomatic stress level. Cortisol reference values are: 3.7-9.5 ng/mL (morning), 1.2-3.0 ng/mL (noon), 0.6-1.9 ng/mL (evening), 0.4-1.0 ng/mL (bedtime). Higher values have been associated with higher stress.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in both older adults and caregivers of persons with Alzheimer's Disease and Related Dementias.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	7	6	4	15
Mean (Standard Deviation) [ng/mL]	-0.03 (0.1)	0.6 (1.4)	-0.5 (1.2)	2.3 (3.6)

27. Secondary Outcome

Title	Salivary 1,5-Anhydroglucitol (AG)
Description	Change in mean laboratory values of 1,5-Anhydroglucitol (AG) which is a biomarker for glycemic metabolism and is reduced under stressful circumstances. The normal reference value for 1,5 AG is ≥ 14.0 μg/ml.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description
This was measured in both older adults and caregivers of persons with Alzheimer's Disease and Related Dementias.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	7	6	4	15
Mean (Standard Deviation) [μg/ml]	5.3 (4.8)	5.4 (5.2)	3.9 (3.8)	4.8 (0.6)

28. Secondary Outcome

Title	Adherence
Description	Using study data logs, appropriate use of the interventions was measured by the number of participants who adhered to the protocol for engaging in Arm 1 Otago, Arm 2 Otago + Gentle yoga/yogic breathing, Arm 3 behavioral activation (Older adults) or Arm 4 Gentle yoga/yogic breathing (Caregivers). Adherence was defined as the number of participants (rounded up) who completed the study and were at least 80% adherent to the study protocol for frequency of engaging in the assigned Arm during the 12-week study period.
Time Frame	End of study at 12 weeks post intervention

Outcome Measure Data

Analysis Population Description
This was measured in both older adults and caregivers of persons with Alzheimer's Disease and Related Dementias.

Arm/Group Title	Otago	Otago + Gentle Yogic Breathing	Otago + GYYB + Behavioral Activation	Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing	This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.	The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
Measure Participants	7	6	4	15
Number [Participants]	6 60%	4 40%	3 30%	7 35%

Adverse Events

	Otago		Otago + Gentle Yogic Breathing		Otago + GYYB + Behavioral Activation		Caregiver Gentle Yoga & Yogic Breathing
Time Frame	From baseline to 12 weeks end of study.
Adverse Event Reporting Description	Same definitions used

Arm/Group Title	Otago		Otago + Gentle Yogic Breathing		Otago + GYYB + Behavioral Activation		Caregiver Gentle Yoga & Yogic Breathing
Arm/Group Description	The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level. Otago: Exercise program for strength and balance		The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing		This condition will incorporate OEP and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days. Otago: Exercise program for strength and balance Gentle yogic breathing: yogic breathing Behavioral Activation: Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.		The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits. Caregiver Gentle yogic breathing: yogic breathing
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		1/10 (10%)		0/20 (0%)
Serious Adverse Events
	Otago		Otago + Gentle Yogic Breathing		Otago + GYYB + Behavioral Activation		Caregiver Gentle Yoga & Yogic Breathing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		1/10 (10%)		1/10 (10%)		0/20 (0%)
Blood and lymphatic system disorders
Hospitalization	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/20 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumonia	0/0 (NaN)	0	0/10 (0%)	0	1/10 (10%)	1	0/20 (0%)	0
Vascular disorders
Fluid buildup around heart	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/20 (0%)	0
Other (Not Including Serious) Adverse Events
	Otago		Otago + Gentle Yogic Breathing		Otago + GYYB + Behavioral Activation		Caregiver Gentle Yoga & Yogic Breathing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/20 (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	Teresa Kelechi, Associate Dean for Research and PhD Studies
Organization	Medical University of South Carolina
Phone	843-792-4602
Email	kelechtj@musc.edu

Responsible Party:

Teresa Kelechi, Professor, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT03853148

Other Study ID Numbers:

Pr00076835
5P20NR016575-05

First Posted:

Feb 25, 2019

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Activate For Life: mHealth Intervention To Address Pain And Fatigue In Low-income Older Adults Aging In Place

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion and Exclusion Criteria for Older Adults (Arms 1, 2, 3):

Exclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

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Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact