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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Andrea Trombetti, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01811745
First received: March 12, 2013
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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 Intervention
Physical Function
Cognitive Function
Falls
Behavioral: Jaques-Dalcroze eurhythmics training
Behavioral: Multicomponent exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Change in gait variability under dual-task condition [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in gait performances (quantitative gait analysis under single and dual-task conditions) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change in balance performances (quantitative balance analysis) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change in functional tests performances (Timed Up & Go test and Short Physical Performance Battery) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Incidence of falls and fractures (prospective daily recording using calendars, to be returned monthly) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change in cognitive performances (comprehensive neuropsychological battery assessing different aspects of executive functioning) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change in anxiety/depression (Hospital Anxiety and Depression scale) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change in fear of falling (Short-FESI) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in brain networks (structural and functional levels) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    fMRI sub-study


Estimated Enrollment: 140
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811745

Contacts
Contact: Andrea Trombetti, MD (+4122) 372 99 60 andrea.trombetti@hcuge.ch
Contact: Mélany Hars, PhD (+4179) 553 83 18 melany.hars@hcuge.ch

Locations
Switzerland
Bone Diseases Service, Geneva University Hospitals Recruiting
Geneva, Switzerland, 1211
Principal Investigator: Andrea Trombetti, MD         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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

Publications:
Responsible Party: Andrea Trombetti, Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01811745     History of Changes
Other Study ID Numbers: 12-175
Study First Received: March 12, 2013
Last Updated: March 14, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Aged
Cognition
Exercise
Falls
Gait
Physical function
Dual-task
Music
Postural Balance
Randomized controlled trial

ClinicalTrials.gov processed this record on October 21, 2014