This trial is active, not recruiting.

Conditions physical function, cognitive function, falls
Treatments jaques-dalcroze eurhythmics training, multicomponent exercise training
Sponsor University Hospital, Geneva
Start date February 2013
End date February 2015
Trial size 140 participants
Trial identifier NCT01811745, 12-175


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Once-weekly 60-min Jaques-Dalcroze eurhythmics class, for 12 months.
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)
Once-weekly 60-min multicomponent exercise class supplemented by one 30-min home-based exercise session, for 12 months.
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.

Primary Outcomes

Change in gait variability under dual-task condition
time frame: 6 months, 12 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 65 years old.

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)

Additional Information

Official title Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors (EPHYCOS Study)
Principal investigator Andrea Trombetti, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Geneva.