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

NCT01811745 | Completed

• 1 other identifier: 12-175
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in gait variability under dual-task condition

  6 months, 12 months

Secondary Outcomes (7)

• 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

Other Outcomes (1)

• Change in brain networks (structural and functional levels)

  12 months

Study Arms (2)

Jaques-Dalcroze eurhythmics training

EXPERIMENTAL

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

Behavioral: Jaques-Dalcroze eurhythmics training

Multicomponent exercise training

ACTIVE COMPARATOR

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

Behavioral: Multicomponent exercise training

Interventions

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.

Jaques-Dalcroze eurhythmics training

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.

Multicomponent exercise training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Bone Diseases Service, Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 21098340 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Andrea Trombetti, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 15, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

CH (1)