NCT01107288

Brief Summary

The aim of this study is to investigate the effectiveness of a 6-month music-based multitask exercises program (Jaques-Dalcroze eurhythmics) in improving gait and balance, and reducing fall risk in community-dwelling older adults with an increased risk of falling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 24, 2014

Status Verified

February 1, 2014

Enrollment Period

1.8 years

First QC Date

April 19, 2010

Last Update Submit

February 21, 2014

Conditions

Keywords

AgedBalanceDual-taskExerciseFallsGaitMusic

Outcome Measures

Primary Outcomes (1)

  • Change in gait variability

    6 months

Secondary Outcomes (7)

  • Change in other spatio-temporal gait parameters

    6 months, 12 months

  • Change in balance measures (Trunk sway parameters)

    6 months, 12 months

  • Change in functional tests performances (Timed Up & Go test and simplified Tinetti test)

    6 months, 12 months

  • Number of falls, fallers and multiple fallers (Daily recording of falls using falls calendars, to be returned monthly)

    6 months, 12 months

  • Change in quality of life (SF-12 Health Survey questionnaire), anxiety/depression (HAD scale), cognitive function (Mini-Mental State Examination, Frontal Assessment Battery, clock drawing test), nutritional status (Mini Nutritional Assessment tool)

    6 months, 12 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Randomized to receive the intervention first

Other: Music-based multitask exercises program

Delayed intervention control group

OTHER

Randomized to wait-list control first

Other: Music-based multitask exercises program

Interventions

Subjects are entered into a 6-month Jaques-Dalcroze eurhythmics program and are followed for an additional 6 months after the intervention period. They complete assessments at baseline, 6 and 12 months. The program consists of structured 1-hour group exercises classes, conducted weekly by an experimented instructor, that include varied multitask exercises performed to the rhythm of improvised piano music, sometimes with the manipulation of objects (e.g., instruments of percussion, balls), with gradually increasing difficulty over time. Basic exercises consist of walking following the music, responding directly to changes in music's rhythmic patterns.

Also known as: Jaques-Dalcroze Eurhythmics
Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 years or older
  • Living in the community
  • Without previous Jaques-Dalcroze eurhythmics experience (except during childhood)
  • Identified as being at high risk of fall (i.e., one or more self-reported falls after the age of 65 years or balance impairment as assessed by a simplified Tinetti test higher than 2 over 7 or the presence of one or two indicators of physical frailty based on Fried's criteria)

You may not qualify if:

  • Neurological or orthopaedic disease (e.g., stroke with residual motor deficit, Parkinson's disease, osteoarthritis) with a significant impact on gait and balance performances
  • Progressive or unstable medical conditions that could limit participation (e.g., terminal illness)
  • Fully dependent on an assistive device such as canes and walkers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation and Geriatrics, Geneva University Hospitals

Geneva, CH-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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Andrea Trombetti, MD

    Bone Diseases Service, Department of Rehabilitation and Geriatrics, 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
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 20, 2010

Study Start

February 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2012

Last Updated

February 24, 2014

Record last verified: 2014-02

Locations