search
Back to results

Adherence by Music to Exercise in Dementia: Group Therapy (AMUSED)

Primary Purpose

Dementia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Music and video-based group exercise therapy
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Exercise therapy, Rehabilitation, Physical therapy, Frailty, Treatment Adherence and Compliance, Cognition, Physical functioning

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Woonzorgcentrum St.ElisabethRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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 (%)
Attrition rate
The amount of participants that discontinued the program

Secondary Outcome Measures

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.
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.
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.
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.
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".

Full Information

First Posted
October 20, 2022
Last Updated
September 25, 2023
Sponsor
Hasselt University
Collaborators
Stichting Alzheimer Onderzoek
search

1. Study Identification

Unique Protocol Identification Number
NCT05603533
Brief Title
Adherence by Music to Exercise in Dementia: Group Therapy
Acronym
AMUSED
Official Title
The Effectiveness of a Music and Video-based Group Exercise Therapy in Older Adults With Moderate Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Stichting Alzheimer Onderzoek

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Exercise therapy, Rehabilitation, Physical therapy, Frailty, Treatment Adherence and Compliance, Cognition, Physical functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants in the control group will receive no additional therapy.
Intervention Type
Other
Intervention Name(s)
Music and video-based group exercise therapy
Intervention Description
Each exercise session will last up to 45min. The participants will follow this group exercise therapy twice a week for four months.
Primary Outcome Measure Information:
Title
The change in motivation between 1,2,3 and 4 months into the intervention will be measured using the observed emotion rating scale (OERS)
Description
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.
Time Frame
1,2,3 and 4 months of intervention
Title
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.
Description
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.
Time Frame
At baseline, after 2 and 4 months
Title
The change in muscle strength between baseline, mid-intervention and at the end of intervention will be measured using a hand-held dynamometer
Description
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.
Time Frame
At baseline, after 2 and 4 months
Title
The change in compliance between 1,2,3 and 4 months into the intervention will be measured
Description
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.
Time Frame
1,2,3 and 4 months of intervention
Title
The change in adherence between 1,2,3 and 4 months into the intervention will be measured
Description
Adherence will be measured by counting the amount of therapy sessions each participant completed (%)
Time Frame
1,2,3 and 4 months of intervention
Title
Attrition rate
Description
The amount of participants that discontinued the program
Time Frame
Twice a week for 4 months
Secondary Outcome Measure Information:
Title
The change in balance and gait between baseline, mid-intervention and at the end of intervention will be measured using the Tinetti test
Description
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.
Time Frame
At baseline, after 2 and 4 months
Title
The change in activity level and sleep between baseline, mid-intervention and at the end of intervention will be measured using an Actigraph
Description
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.
Time Frame
At baseline, after 2 and 4 months
Title
The change in cognition between baseline, mid-intervention and at the end of intervention will be assessed using the Montreal Cognitive Assessment (MOCA)
Description
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.
Time Frame
At baseline, after 2 and 4 months
Title
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)
Description
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.
Time Frame
At baseline, after 2 and 4 months
Title
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)
Description
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".
Time Frame
At baseline, after 2 and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tine Plattiau, Msc
Phone
+3211268323
Email
tine.plattiau@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Joke Spildooren, Prof. dr.
Phone
+3211269178
Email
joke.spildooren@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joke Spildooren, Prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Study Director
Facility Information:
Facility Name
Woonzorgcentrum St.Elisabeth
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter Ruyseveldt
Phone
+3211269697
Email
campusdirectiehasselt@begralim.be
First Name & Middle Initial & Last Name & Degree
Johan Abrahams
Email
directie@begralim.be

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

Adherence by Music to Exercise in Dementia: Group Therapy

We'll reach out to this number within 24 hrs