DementiaAMUSEDNCT05603533
Adherence by Music to Exercise in Dementia: Group Therapy
A study testing Music and video-based group exercise therapy in people with Dementia, run by Hasselt University at 4 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Music and video-based group exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesBelgium
- Study dates
- 9 Jan 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Inadequate functional hearing
- Uncorrected visual problems
- Rehabilitating from an orthopedic or neurologic insult
- Known disability that significantly influences 6 month prognosis
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites, 2 recruiting
- Completed
Woonzorgcentrum Beversthuis
Beverst, Limburg, 3740
- Completed
Woonzorgcentrum St.Elisabeth
Hasselt, Limburg, 3500
- Recruiting
Aquamarijn
Kasterlee, Antwerpen, 2460
Wendy Van Peer, Aquamarijn.dir@animagroup.be
- Recruiting
Woonzorgcentrum Kimpenhof
Opglabbeek, Limburg, 3660
Christel Cleuren, +3289365700, christel.cleuren@kimpenhof.be
About this study
Official title: The Effectiveness of a Music and Video-based Group Exercise Therapy in Older Adults With Moderate Dementia
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
- Being tested
- Music and video-based group exercise therapy
- Keywords
- Exercise therapy, Rehabilitation, Physical therapy, Frailty, Treatment Adherence and Compliance, Cognition, Physical functioning
- Medical subject headings
- Dementia, Frailty, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music and video-based group exercise therapyOther
Each exercise session will last up to 45min. The participants will follow this group exercise therapy twice a week for four months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Music and video-based group exercise therapy |
| Control group | No intervention | The participants in the control group will receive no additional therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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 (%)
Measured: 1,2,3 and 4 months of intervention
Attrition rate
The amount of participants that discontinued the program
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: At baseline, after 2 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start9 Jan 2023
- Primary completionApr 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Alzheimer Onderzoek
- Responsible party
- Principal investigator, Tinne Plattiau, Hasselt University
- Investigators
- Joke Spildooren, Prof. dr., Study director, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603533
- Sponsor's protocol ID
- AMUSED STUDY 1
- Acronym
- AMUSED
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant data will be shared among collaborating researchers within Hasselt University via Google Drive. Within Google Drive, there is a division into 3 categories for access rights to personal data. To category 1 belongs only the responsible local researcher who has access to all personal data, including the log of subjects with the link between the identity and the encrypted data. To category 2 belong all employees of the research team. They have access to the pseudonymized data. To category 3 belong the master's thesis students. They only have access to the pseudonymized data relevant to their master's thesis.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Music and Video-based Group Exercise Therapy in Older Adults With Moderate Dementia
- ClinicalTrials.gov ID
- NCT05603533
- Acronym / sponsor ID
- AMUSED / AMUSED STUDY 1
- Conditions
- Dementia
- Keywords
- Exercise therapy, Rehabilitation, Physical therapy, Frailty, Treatment Adherence and Compliance, Cognition, Physical functioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Stichting Alzheimer Onderzoek
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Music and video-based group exercise therapyOn 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. |
| Control group | No intervention | –The participants in the control group will receive no additional therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Inadequate functional hearing
- Uncorrected visual problems
- Rehabilitating from an orthopedic or neurologic insult
- Known disability that significantly influences 6 month prognosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music and video-based group exercise therapyEach exercise session will last up to 45min. The participants will follow this group exercise therapy twice a week for four months. | Other | Intervention group |
Primary outcome
The change in motivation between 1,2,3 and 4 months into the intervention will be measured using the observed emotion rating scale (OERS)
Time frame: 1,2,3 and 4 months of intervention
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.
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.
Time frame: At baseline, after 2 and 4 months
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.
The change in muscle strength between baseline, mid-intervention and at the end of intervention will be measured using a hand-held dynamometer
Time frame: At baseline, after 2 and 4 months
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.
The change in compliance between 1,2,3 and 4 months into the intervention will be measured
Time frame: 1,2,3 and 4 months of intervention
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.
The change in adherence between 1,2,3 and 4 months into the intervention will be measured
Time frame: 1,2,3 and 4 months of intervention
Adherence will be measured by counting the amount of therapy sessions each participant completed (%)
Attrition rate
Time frame: Twice a week for 4 months
The amount of participants that discontinued the program
5 secondary outcomes
The change in balance and gait between baseline, mid-intervention and at the end of intervention will be measured using the Tinetti test
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At baseline, after 2 and 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Yes. Relevant data will be shared among collaborating researchers within Hasselt University via Google Drive. Within Google Drive, there is a division into 3 categories for access rights to personal data. To category 1 belongs only the responsible local researcher who has access to all personal data, including the log of subjects with the link between the identity and the encrypted data. To category 2 belong all employees of the research team. They have access to the pseudonymized data. To category 3 belong the master's thesis students. They only have access to the pseudonymized data relevant to their master's thesis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joke Spildooren, Prof. dr. study director
Hasselt University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and video-based group exercise therapy in people with Dementia, run by Hasselt University at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tine Plattiau, Msc (+3211268323, tine.plattiau@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in motivation between 1,2,3 and 4 months into the intervention will be measured using the observed emotion rating scale (OERS) (time frame: 1,2,3 and 4 months of intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.