Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and the possible mechanisms underlying music-based multitask training (i.e., Jaques-Dalcroze eurhythmics) in older people, compared to multicomponent exercise training. This study is designed as a 12-month, prospective, single-centre, single-blind, 2-arm, parallel group, randomized controlled trial in which 140 community-dwelling older adults at high risk of falls are randomly assigned to receive either a music-based multitask training intervention (i.e., Jaques-Dalcroze eurhythmics) or a multicomponent exercise training intervention, for 12 months. A 12-month follow-up is planned with outcome measures assessed at three time points: baseline (before intervention initiation), 6-month (intervention mid-point), and 12-month (intervention termination). Outcomes of interest include physical and cognitive performances, and falls. In addition, the investigators specifically address brain circuits in an exploratory sub-study. Volunteer trial participants from both study arms are invited to undergo functional magnetic resonance imaging (fMRI) at baseline and 12-month.

Official Title
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Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors (EPHYCOS Study)

Conditions
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Physical Function, Cognitive Function, Falls

Intervention / Treatment
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* Behavioral: Jaques-Dalcroze eurhythmics training
* Behavioral: Multicomponent exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged ≥ 65 years (no upper age limit) living in the community, even in protected housing identified as being at high risk of falls (i.e., one or more self-reported falls after the age of 65 years or balance impairment as assessed by a simplified Tinetti test or presence of one or two indicators of physical frailty based on Fried's criteria) willing to comply with all study requirements Exclusion Criteria: neurological or orthopaedic disease (e.g., stroke with residual motor deficit, Parkinson's disease) with a significant impact on gait and balance performances fully dependent on a technical aid for walking such as canes or walker diagnosis of dementia based on a comprehensive neuropsychological assessment participation in a Jaques-Dalcroze Eurhythmics program or a supervised multicomponent exercise program in the past 12 months serious medical conditions or other factors that may limit adherence to interventions or affect conduct of the trial (e.g., terminal illness)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaques-Dalcroze eurhythmics training<br>Once-weekly 60-min Jaques-Dalcroze eurhythmics class, for 12 months. | Behavioral: Jaques-Dalcroze eurhythmics training<br>* 12 months of weekly, supervised, structured, progressive, 60-min music-based multitask exercise classes (i.e., Jaques-Dalcroze eurhythmics). The music-based multitask program includes all exercises used in a previous work.<br>|
| Active Comparator: Multicomponent exercise training<br>Once-weekly 60-min multicomponent exercise class supplemented by one 30-min home-based exercise session, for 12 months. | Behavioral: Multicomponent exercise training<br>* 12 months of weekly, i) supervised, structured, progressive, 60-min multicomponent exercise classes, supplemented by ii) 30-min home-based exercise sessions. Briefly, the multimodal exercise program is based on core components for successful fall prevention in older adults. It contains balance, gait, coordination and strength training, with balance as a core component.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gait variability under dual-task condition |  | 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gait performances (quantitative gait analysis under single and dual-task conditions) |  | 6 months, 12 months | 
| Change in balance performances (quantitative balance analysis) |  | 6 months, 12 months | 
| Change in functional tests performances (Timed Up & Go test and Short Physical Performance Battery) |  | 6 months, 12 months | 
| Incidence of falls and fractures (prospective daily recording using calendars, to be returned monthly) |  | 6 months, 12 months | 
| Change in cognitive performances (comprehensive neuropsychological battery assessing different aspects of executive functioning) |  | 6 months, 12 months | 
| Change in anxiety/depression (Hospital Anxiety and Depression scale) |  | 6 months, 12 months | 
| Change in fear of falling (Short-FESI) |  | 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aged, Cognition, Exercise, Falls, Gait, Physical function, Dual-task, Music, Postural Balance, Randomized controlled trial