Adherence by Music to Exercise in Dementia: Group Therapy

ConditionDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHasselt University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inadequate functional hearing

Uncorrected visual problems

Rehabilitating from an orthopedic or neurologic insult

Known disability that significantly influences 6 month prognosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Music and video-based group exercise therapy

    Other intervention

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

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hasselt University

Lead sponsor

Stichting Alzheimer Onderzoek

Collaborator