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

NCT ID: NCT01811745

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-05-31

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.

Conditions

Physical Function; Cognitive Function; Falls

Keywords

Aged; Cognition; Exercise; Falls; Gait; Physical function; Dual-task; Music; Postural Balance; Randomized controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Jaques-Dalcroze eurhythmics training

Once-weekly 60-min Jaques-Dalcroze eurhythmics class, for 12 months.

Group Type: EXPERIMENTAL

Jaques-Dalcroze eurhythmics training

Intervention Type: 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

Once-weekly 60-min multicomponent exercise class supplemented by one 30-min home-based exercise session, for 12 months.

Group Type: ACTIVE_COMPARATOR

Multicomponent exercise training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Andrea Trombetti

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Trombetti, MD

Role: PRINCIPAL_INVESTIGATOR

Bone Diseases Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva

Locations

Bone Diseases Service, Geneva University Hospitals

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 21098340 (View on PubMed)

Other Identifiers

12-175

Identifier Type: -

Identifier Source: org_study_id