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Recruiting NCT05603533

Adherence by Music to Exercise in Dementia: Group Therapy

No phase Interventional Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music and video-based group exercise therapy.
Who it may be relevant to
Registry conditions: Dementia. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effectiveness of a Music and Video-based Group Exercise Therapy in Older Adults With Moderate Dementia

Overview

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.

Interventions

  • Other Music and video-based group exercise therapy
    Each exercise session will last up to 45min. The participants will follow this group exercise therapy twice a week for four months.

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) [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. [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 [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 [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 [Time frame: 1,2,3 and 4 months of intervention]
  • Attrition rate [Time frame: Twice a week for 4 months]
Secondary outcome measures (5)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Belgium · 4 centers
  • Aquamarijn — Kasterlee
  • Woonzorgcentrum Beversthuis — Beverst
  • Woonzorgcentrum St.Elisabeth — Hasselt
  • Woonzorgcentrum Kimpenhof — Opglabbeek

Identifiers

NCT: NCT05603533 · AMUSED STUDY 1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗