Movement and Music Intervention for Individuals With Dementia

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03121950
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The goal of the study is to learn about how possible benefits of movement and music for individuals with dementia. Individuals with dementia will participate in a dance class. The study includes assessments of walking, balance and cognition.

Condition or Disease	Intervention/Treatment	Phase
Dementia With Lewy Bodies; Dementia	Other: Dance; Other: Music	N/A

Detailed Description

Dementia impacts 5%-7% of individuals >60 years old. It impacts the person's ability to perform work, care for him/herself and ultimately leads to physical disability. There is a high caregiver burden associated with dementia and many individuals require care in a long-term care facility. There is some emerging evidence that music based interventions may have a protective effect on the brain in those with dementia. There is also evidence that doing activities that engage the brain through music are beneficial. This study seeks to investigate the potential benefits of a music based intervention for individuals with dementia. The study aims to recruit individuals with a diagnosis of dementia. Once enrolled participants will undergo assessment of walking, balance and cognition and then be asked to participate either in a dance class or to listen to live music. After 6 weeks and again at the end of the study (after 12 weeks) participants will undergo assessments of walking, balance and cognition.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be placed in one of two groups. One group will participate 2 times a week in a dance class. The other group will listen to live music once a week.Participants will be placed in one of two groups. One group will participate 2 times a week in a dance class. The other group will listen to live music once a week.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Movement and Music Intervention for Individuals With Dementia
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Dec 30, 2017
• Actual Study Completion Date: Dec 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dance in dementia examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.	Other: Dance; The primary intervention is a dance class
Active Comparator: Music and dementia examine if listening to music improves mobility and/or cognition in individuals with dementia.	Other: Music; the secondary intervention is listening to live music

Outcome Measures

Primary Outcome Measures

1. Timed up and go Cognitive [12 weeks]

   The change in time to complete the Timed Up and Go - Cognitive (TUG-Cog) is recorded in seconds. The participant is timed with a stop watch while walking 3 meters turning and returning to a chair while performing a concurrent cognitive task. This time is compared to the Timed Up and Go (TUG) and the difference in time indicates the effect cognitive deficits have on motor function. Higher scores, indicating more time, means worse outcomes.

Secondary Outcome Measures

1. Change in Score on the Montreal Cognitive Assessment [12 weeks]

   The Montreal Cognitive Assessment (MoCA) is an assessment of overall cognitive status. The range of scores is 0-30, with higher scores indicating better outcomes. Scores 26 or higher indicates normal cognitive function.

Other Outcome Measures

1. Change in Score on the Caregiver Burden Scale [12 weeks]

   A questionnaire asking caregivers about the impact of caregiving on daily life. Scores range from 0-88, with higher scores indicating worse outcomes or more burden. Scores of 0-20 = little or no burden, 21-40 = mild to moderate burden, 41-60 = moderate to severe burden, and 61-80 = severe burden.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of dementia

• Mini-Mental State Examination score > 9

• Age > 60 years

• Able to follow simple instructions

Exclusion Criteria:

• Unable to walk 10 feet unassisted

• Presence of orthopedic disorder that impacts walking

• Presence of other neurologic diagnosis that impacts cognitive or motor function such as stroke, Parkinson disease or traumatic brain injury

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: Deb Kegelmeyer, DPT, Ohio State University

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Sep 8, 2017

More Information

Publications

None provided.

• Responsible Party: Deb Kegelmeyer, Professor Clinical, Ohio State University
• ClinicalTrials.gov Identifier: NCT03121950
• Other Study ID Numbers: 2016H0211
• First Posted: Apr 20, 2017
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Deb Kegelmeyer, Professor Clinical, Ohio State University: dementia
• Additional relevant MeSH terms: Dementia; Alzheimer Disease; Lewy Body Disease

Study Results

Participant Flow

Pre-assignment Detail	1 participant was excluded due to not meeting criteria on minimum score required for participation on the Mini Mental Status Examination

Arm/Group Title	Dance in Dementia	Music and Dementia
Arm/Group Description	examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.	examine if listening to music improves mobility and/or cognition in individuals with dementia.
Period Title: Overall Study
STARTED	17	3
COMPLETED	6	1
NOT COMPLETED	11	2

Baseline Characteristics

Arm/Group Title	Dance in Dementia	Music and Dementia	Total
Arm/Group Description	examine if participating in a dance class improves mobility and/or cognition in individuals with dementia. Dance: The primary intervention is a dance class	examine if listening to music improves mobility and/or cognition in individuals with dementia. music: the secondary intervention is listening to live music	Total of all reporting groups
Overall Participants	17	3	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	17 100%	3 100%	20 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	83.76 (7.55)	74 (11.36)	82.3 (8.62)
Sex: Female, Male (Count of Participants)
Female	9 52.9%	2 66.7%	11 55%
Male	8 47.1%	1 33.3%	9 45%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	17 100%	3 100%	20 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	17 100%	3 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Timed up and go Cognitive
Description	The change in time to complete the Timed Up and Go - Cognitive (TUG-Cog) is recorded in seconds. The participant is timed with a stop watch while walking 3 meters turning and returning to a chair while performing a concurrent cognitive task. This time is compared to the Timed Up and Go (TUG) and the difference in time indicates the effect cognitive deficits have on motor function. Higher scores, indicating more time, means worse outcomes.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dance in Dementia	Music and Dementia
Arm/Group Description	examine if participating in a dance class improves mobility and/or cognition in individuals with dementia. Dance: The primary intervention is a dance class	examine if listening to music improves mobility and/or cognition in individuals with dementia. music: the secondary intervention is listening to live music
Measure Participants	6	1
Mean (Standard Deviation) [seconds]	-6.49 (9.66)	-13.35 (0)

2. Secondary Outcome

Title	Change in Score on the Montreal Cognitive Assessment
Description	The Montreal Cognitive Assessment (MoCA) is an assessment of overall cognitive status. The range of scores is 0-30, with higher scores indicating better outcomes. Scores 26 or higher indicates normal cognitive function.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dance in Dementia	Music and Dementia
Arm/Group Description	examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.	examine if listening to music improves mobility and/or cognition in individuals with dementia.
Measure Participants	6	1
Mean (Standard Deviation) [score on a scale]	-1.5 (2.07)	0 (0)

3. Other Pre-specified Outcome

Title	Change in Score on the Caregiver Burden Scale
Description	A questionnaire asking caregivers about the impact of caregiving on daily life. Scores range from 0-88, with higher scores indicating worse outcomes or more burden. Scores of 0-20 = little or no burden, 21-40 = mild to moderate burden, 41-60 = moderate to severe burden, and 61-80 = severe burden.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dance in Dementia	Music and Dementia
Arm/Group Description	examine if participating in a dance class improves mobility and/or cognition in individuals with dementia. Dance: The primary intervention is a dance class	examine if listening to music improves mobility and/or cognition in individuals with dementia. music: the secondary intervention is listening to live music
Measure Participants	6	1
Mean (Standard Deviation) [score on a scale]	-5.17 (8.51)	-7 (0)

Adverse Events

Time Frame	1 year
Arm/Group Title	Dance in Dementia		Music and Dementia
Arm/Group Description	examine if participating in a dance class improves mobility and/or cognition in individuals with dementia. Dance: The primary intervention is a dance class		examine if listening to music improves mobility and/or cognition in individuals with dementia. music: the secondary intervention is listening to live music
All Cause Mortality
	Dance in Dementia		Music and Dementia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/3 (0%)
Serious Adverse Events
	Dance in Dementia		Music and Dementia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Dance in Dementia		Music and Dementia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/3 (0%)

Limitations/Caveats

Our study had many limitations including significant barriers to recruitment and retention of participants. Because of this, we changed the design to a pretest-posttest pilot study and included data from a participant at 6 weeks in the manuscript.

More Information

Certain Agreements

All Principal Investigators ARE 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.