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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Falls; Physical Function
• Intervention / Treatment: Behavioral: Jaques-Dalcroze eurhythmics training; Behavioral: Multicomponent exercise training

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Bone Diseases Service, Geneva University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in gait variability under dual-task condition	6 months, 12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in brain networks (structural and functional levels)	fMRI sub-study	12 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Trombetti A, Hars M, Herrmann FR, Kressig RW, Ferrari S, Rizzoli R. Effect of music-based multitask training on gait, balance, and fall risk in elderly people: a randomized controlled trial. Arch Intern Med. 2011 Mar 28;171(6):525-33. doi: 10.1001/archinternmed.2010.446. Epub 2010 Nov 22.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 14, 2013
• First Posted (ESTIMATE): March 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Exercise; Gait; Randomized controlled trial; Cognition; Postural Balance; Aged; Dual-task; Physical function; Music; Falls
• Other Study ID Numbers: 12-175