Adherence by Music to Exercise in Dementia: Group Therapy

Dementia Clinical Trial

— AMUSED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603533
• Other study ID #: AMUSED STUDY 1
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: Hasselt University
• Contact: Tine Plattiau, Msc
• Phone: +3211268323
• Email: tine.plattiau[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Music and video-based group exercise therapy
Each exercise session will last up to 45min. The participants will follow this group exercise therapy twice a week for four months.

Locations

Country	Name	City	State
Belgium	Woonzorgcentrum St.Elisabeth	Hasselt	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Stichting Alzheimer Onderzoek

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Attrition rate	The amount of participants that discontinued the program	Twice a week for 4 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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