Clinical trial NCT05603533: Adherence by Music to Exercise in Dementia: Group Therapy
Official title: The Effectiveness of a Music and Video-based Group Exercise Therapy in Older Adults With Moderate Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Keywords: Exercise therapy
Rehabilitation
Physical therapy
Frailty
Treatment Adherence and Compliance
Cognition
Physical functioning
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Stichting Alzheimer Onderzoek
First posted: 2022-11-02
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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)
timeFrame: 1,2,3 and 4 months of intervention
measure: 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.
timeFrame: At baseline, after 2 and 4 months
measure: The change in muscle strength between baseline, mid-intervention and at the end of intervention will be measured using a hand-held dynamometer
timeFrame: At baseline, after 2 and 4 months
measure: The change in compliance between 1,2,3 and 4 months into the intervention will be measured
timeFrame: 1,2,3 and 4 months of intervention
measure: The change in adherence between 1,2,3 and 4 months into the intervention will be measured
timeFrame: 1,2,3 and 4 months of intervention
measure: Attrition rate
timeFrame: Twice a week for 4 months
Secondary outcomes:
measure: The change in balance and gait between baseline, mid-intervention and at the end of intervention will be measured using the Tinetti test
timeFrame: At baseline, after 2 and 4 months
measure: The change in activity level and sleep between baseline, mid-intervention and at the end of intervention will be measured using an Actigraph
timeFrame: At baseline, after 2 and 4 months
measure: The change in cognition between baseline, mid-intervention and at the end of intervention will be assessed using the Montreal Cognitive Assessment (MOCA)
timeFrame: At baseline, after 2 and 4 months
measure: 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)
timeFrame: At baseline, after 2 and 4 months
measure: 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)
timeFrame: At baseline, after 2 and 4 months
Other outcomes:
Locations:
city: Kasterlee
country: Belgium
facility: Aquamarijn
state: Antwerpen
city: Beverst
country: Belgium
facility: Woonzorgcentrum Beversthuis
state: Limburg
city: Hasselt
country: Belgium
facility: Woonzorgcentrum St.Elisabeth
state: Limburg
city: Opglabbeek
country: Belgium
facility: Woonzorgcentrum Kimpenhof
state: Limburg
Study officials:
affiliation: Hasselt University
name: Joke Spildooren, Prof. dr.
role: STUDY_DIRECTOR
References: