Adherence by Music to Exercise in Dementia: Group Therapy

NCT05603533 | Recruiting

• 1 other identifier: AMUSED STUDY 1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Dementia

Keywords

Exercise therapy; Rehabilitation; Physical therapy; Frailty; Treatment Adherence and Compliance; Cognition; Physical functioning

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• The change in balance and gait between baseline, mid-intervention and at the end of intervention will be measured using the Tinetti test

  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

  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)

  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)

  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)

  At baseline, after 2 and 4 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The participants in the control group will receive no additional therapy.

Interventions

Music and video-based group exercise therapy OTHER

Each exercise session will last up to 45min. The participants will follow this group exercise therapy twice a week for four months.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inadequate functional hearing
• Uncorrected visual problems
• Rehabilitating from an orthopedic or neurologic insult
• Known disability that significantly influences 6 month prognosis

Sponsors & Collaborators

• Hasselt University: lead
• Stichting Alzheimer Onderzoek: collaborator

Study Sites (4)

Aquamarijn

Kasterlee, Antwerpen, 2460, Belgium

RECRUITING

Woonzorgcentrum Beversthuis

Beverst, Limburg, 3740, Belgium

COMPLETED

Woonzorgcentrum St.Elisabeth

Hasselt, Limburg, 3500, Belgium

COMPLETED

Woonzorgcentrum Kimpenhof

Opglabbeek, Limburg, 3660, Belgium

RECRUITING

MeSH Terms

Conditions

Dementia; Frailty; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Joke Spildooren, Prof. dr.

  Hasselt University

  STUDY DIRECTOR

Central Study Contacts

Tine Plattiau, Msc

CONTACT

+3211268323; tine.plattiau@uhasselt.be

Joke Spildooren, Prof. dr.

CONTACT

+3211269178; joke.spildooren@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 2, 2022
• Study Start: January 9, 2023
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

BE (4)