Adherence by Music to Exercise in Dementia: Group Therapy

Study Overview
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Brief Summary
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The aim of this study is to asses the effect of a music and video-based group exercise therapy on motivation, physical functioning, cognition and well-being in older adults with moderate dementia.

Official Title
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The Effectiveness of a Music and Video-based Group Exercise Therapy in Older Adults With Moderate Dementia

Conditions
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Dementia

Intervention / Treatment
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* Other: Music and video-based group exercise therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with moderate dementia (MMSE between 12 and 20) Age 65 years or older Resident in nursing home for at least 30 days Able to stand (supported) for 10 seconds with supervision Exclusion Criteria: Inadequate functional hearing Uncorrected visual problems Rehabilitating from an orthopedic or neurologic insult Known disability that significantly influences 6 month prognosis

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>On top of the regular physical therapy, the participants in the intervention group will receive a music and video-based group exercise therapy in small groups of 5. On a big screen, a video of an older woman performing exercises will be shown, the participants will have to copy these exercises. In the beginning of each session, the participants will be able to choose the music they want to move to. | Other: Music and video-based group exercise therapy<br>* Each exercise session will last up to 45min. The participants will follow this group exercise therapy twice a week for four months.<br>|
| No Intervention: Control group<br>The participants in the control group will receive no additional therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in motivation between 1,2,3 and 4 months into the intervention will be measured using the observed emotion rating scale (OERS) | The OERS evaluates the positive (pleasure, interest/alertness) and negative mood (anger, anxiety, sadness) by observing the extent or duration of facial expressions and body movements and has a moderate to high interrater reliability. To evaluate the OERS, two exercise sessions will be recorded each month and results will be averaged to compensate for daily fluctuations. | 1,2,3 and 4 months of intervention | 
| The change in muscle strength between baseline, mid-intervention and at the end of intervention will be measured using the modified timed chair stand test. | The timed chair stand test is a valid and reliable test to evaluate muscle strength in older adults. The participant will be asked to stand up and sit back down on a chair five times without using their hands. The time it takes to perform this task will be measured. | At baseline, after 2 and 4 months | 
| The change in muscle strength between baseline, mid-intervention and at the end of intervention will be measured using a hand-held dynamometer | When using the hand-held dynamometer to measure strength, the break technique will be used. The examiner will apply resistance in a fixed position and the person being tested exerts a maximum effort against the dynamometer for 3-5 seconds. At the last second, the examiner applies a resistance sufficient to overcome the maximum effort of the person being tested and cause the subject's joint to move. | At baseline, after 2 and 4 months | 
| The change in compliance between 1,2,3 and 4 months into the intervention will be measured | Compliance will be measured by assessing whether the participants exercised at the prescribed intensity. To evaluate compliance, two exercises sessions will be recorded and results will be averaged to compensate for daily fluctuations. Both quality and quantity of the participants' performances will be scored. To measure the quantity, the amount of repetitions the participant performed will be rated from zero (no repetitions) to three (all repetitions). A score of two was chosen as cut-off score, indicating that more than half of the exercises were performed. To measure quality, the recorded performances will be compared with the visual instructions on the TV-screen and will be scored on a scale from zero (no repetitions) to three (the performance matched completely with the instructions). A score of two was chosen as cut-off score, indicating that more than half of the exercises were matched with the instructions. | 1,2,3 and 4 months of intervention | 
| The change in adherence between 1,2,3 and 4 months into the intervention will be measured | Adherence will be measured by counting the amount of therapy sessions each participant completed (%) | 1,2,3 and 4 months of intervention | 
| Attrition rate | The amount of participants that discontinued the program | Twice a week for 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in balance and gait between baseline, mid-intervention and at the end of intervention will be measured using the Tinetti test | The Tinetti test was developed to assess gait and balance in older adults and to assess perception of balance and stability during activities of daily living and fear of falling. It's also used as an indicator of the fall risk of an individual. During the test, the participant will be asked to perform certain tasks. The examiner will look at certain key points to score these tasks. | At baseline, after 2 and 4 months | 
| The change in activity level and sleep between baseline, mid-intervention and at the end of intervention will be measured using an Actigraph | The actigraph is a validated, 3 axis accelerometer that will be used to measure activity level (inactivity/sedentary behavior as well as general restlessness and wandering behavior) and sleep. The device will be worn for five consecutive days. During the day, the actigraph will be worn at the hip to measure activity and during the night, the actigraph will be worn at the wrist to measure sleep. | At baseline, after 2 and 4 months | 
| The change in cognition between baseline, mid-intervention and at the end of intervention will be assessed using the Montreal Cognitive Assessment (MOCA) | The MoCA is a tool used to determine if cognitive impairment is present. It takes around ten minutes to complete. It evaluates visuospatial skills, attention, language, abstract reasoning, delayed recall, executive function, and orientation. | At baseline, after 2 and 4 months | 
| The change in quality of life between baseline, mid-intervention and at the end of intervention will be assessed using the ICEpop CAPability measure for Older people (ICECAP-O) | The ICECAP-O questionnaire is validated self-report measure for quality of life in older adults with mild and moderate dementia. The ICECAP-O focuses on a broader sense of wellbeing, rather than only health related quality of life. The measure covers attributes of wellbeing that were found to be important to older adults. | At baseline, after 2 and 4 months | 
| The change in behavioral and psychological symptoms of dementia between baseline, mid-intervention and at the end of intervention will be evaluated using the Dutch version of the Cohen-Mansfield Agitation Inventory (CMAI-D) | The CMAI-D is a 29-item scale to assess agitation. The participants are rated by the staff of the nursing home regarding the frequency with which, over the past two weeks, they manifested agitated behaviors. Each item is rated on a 7-point scale ranging from Never to Several times per hour. | At baseline, after 2 and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise therapy, Rehabilitation, Physical therapy, Frailty, Treatment Adherence and Compliance, Cognition, Physical functioning