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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
Sponsor:
Information provided by (Responsible Party):
Andrea Trombetti, University Hospital, Geneva

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in gait variability under dual-task condition [ Time Frame: 6 months, 12 months ]

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

Other Outcome Measures:
  1. Change in brain networks (structural and functional levels) [ Time Frame: 12 months ]
    fMRI sub-study


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Switzerland
Bone Diseases Service, Geneva University Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Andrea Trombetti, MD Bone Diseases Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva
More Information
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Publications:

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Responsible Party: Andrea Trombetti, Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01811745    
Other Study ID Numbers: 12-175
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by Andrea Trombetti, University Hospital, Geneva:
Aged
Cognition
Exercise
Falls
Gait
 Physical function
Dual-task
Music
Postural Balance
Randomized controlled trial