Movement and Music Intervention for Individuals With Dementia
Primary Purpose
Dementia With Lewy Bodies, Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dance
Music
Sponsored by
About this trial
This is an interventional treatment trial for Dementia With Lewy Bodies focused on measuring dementia
Eligibility Criteria
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
Sites / Locations
- Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dance in dementia
Music and dementia
Arm 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.
Outcomes
Primary Outcome Measures
Timed up and go Cognitive
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
Change in Score on the Montreal Cognitive Assessment
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.
Full Information
NCT ID
NCT03121950
First Posted
April 10, 2017
Last Updated
September 11, 2020
Sponsor
Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT03121950
Brief Title
Movement and Music Intervention for Individuals With Dementia
Official Title
Movement and Music Intervention for Individuals With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Lewy Bodies, Dementia
Keywords
dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dance in dementia
Arm Type
Experimental
Arm Description
examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.
Arm Title
Music and dementia
Arm Type
Active Comparator
Arm Description
examine if listening to music improves mobility and/or cognition in individuals with dementia.
Intervention Type
Other
Intervention Name(s)
Dance
Intervention Description
The primary intervention is a dance class
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
the secondary intervention is listening to live music
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
Other Pre-specified Outcome Measures:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deb Kegelmeyer, DPT
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Movement and Music Intervention for Individuals With Dementia
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