Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors (EPHYCOS)
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|ClinicalTrials.gov Identifier: NCT01811745|
Recruitment Status : Completed
First Posted : March 15, 2013
Last Update Posted : November 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Physical Function Cognitive Function Falls||Behavioral: Jaques-Dalcroze eurhythmics training Behavioral: Multicomponent exercise training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors (EPHYCOS Study)|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||May 2015|
Experimental: Jaques-Dalcroze eurhythmics training
Once-weekly 60-min Jaques-Dalcroze eurhythmics class, for 12 months.
Behavioral: Jaques-Dalcroze eurhythmics training
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.
Active Comparator: Multicomponent exercise training
Once-weekly 60-min multicomponent exercise class supplemented by one 30-min home-based exercise session, for 12 months.
Behavioral: Multicomponent exercise training
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.
- Change in gait variability under dual-task condition [ Time Frame: 6 months, 12 months ]
- Change in gait performances (quantitative gait analysis under single and dual-task conditions) [ Time Frame: 6 months, 12 months ]
- Change in balance performances (quantitative balance analysis) [ Time Frame: 6 months, 12 months ]
- Change in functional tests performances (Timed Up & Go test and Short Physical Performance Battery) [ Time Frame: 6 months, 12 months ]
- Incidence of falls and fractures (prospective daily recording using calendars, to be returned monthly) [ Time Frame: 6 months, 12 months ]
- Change in cognitive performances (comprehensive neuropsychological battery assessing different aspects of executive functioning) [ Time Frame: 6 months, 12 months ]
- Change in anxiety/depression (Hospital Anxiety and Depression scale) [ Time Frame: 6 months, 12 months ]
- Change in fear of falling (Short-FESI) [ Time Frame: 6 months, 12 months ]
- Change in brain networks (structural and functional levels) [ Time Frame: 12 months ]fMRI sub-study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811745
|Bone Diseases Service, Geneva University Hospitals|
|Geneva, Switzerland, 1211|
|Principal Investigator:||Andrea Trombetti, MD||Bone Diseases Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva|