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Completed

NCT Number: NCT01811745

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

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.

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Key information

Conditions

Physical Function Behavior Cognitive Function Falls Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bone Diseases Service, Geneva University Hospitals

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Jaques-Dalcroze eurhythmics training

Behavioral

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.

Multicomponent exercise training

Behavioral

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

  1. Change in gait variability under dual-task condition

    Time frame: 6 months, 12 months

Secondary outcomes

  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 outcomes

  1. Change in brain networks (structural and functional levels)

    Time frame: 12 months

    fMRI sub-study

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Acronym: EPHYCOS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 15, 2013
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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