An interventional study of Music and video-based group exercise therapy in Dementia, sponsored by Hasselt University. Recruiting at 4 sites in Belgium. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Hasselt University · Not applicable, Interventional, and Treatment
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.
2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's planned enrollment of 75 is close to the median of 83 across 1,669 interventional studies indexed under Dementia.
Browse Dementia studies →Hasselt University is the lead sponsor of 203 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
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
The participants in the control group will receive no additional therapy.
Each exercise session will last up to 45min. The participants will follow this group exercise therapy twice a week for four months.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 (%)
Time frame: 1,2,3 and 4 months of intervention
Attrition rate
The amount of participants that discontinued the program
Time frame: Twice a week for 4 months
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.
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
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
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.
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)
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
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".
Time frame: At baseline, after 2 and 4 months
Plan to share: 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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