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GaitNCT01107288

Effects of a Music-Based Multitask Exercises Program on Gait, Balance and Fall Risk in the Elderly

A study testing Music-based multitask exercises program in people with Gait and Balance, run by University Hospital, Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Gait, Balance, Falls
What is being tested?
Music-based multitask exercises program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteSwitzerland
Study dates
Feb 2008to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Department of Rehabilitation and Geriatrics, Geneva University Hospitals

    Geneva, CH-1211

Other trials in Switzerland

About this study

Official title: A Randomized Controlled Trial of Music-Based Multitask Exercises (Jaques-Dalcroze Eurhythmics) on Gait, Balance and Fall Risk in the Elderly

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.

Read the detailed description

Background

Falls are among the most common and devastating concern facing older adults. The scope of this problem will continue to expand as the number of older adults is projected to increase dramatically over the coming decades. Since most falls occur as a result of a complex interaction of risk factors, considerable evidence documents that gait instability and poor balance capacity are two major contributors to falling. A large proportion of falls in elderly people are experienced while walking and, with advancing age, older adults are more likely to fall when they are engaged in concurrent tasks. Gait variability, particularly during dual-task walking conditions, may provide an objective measure to characterize impaired execution of gait, with greater variability placing older adults at increased risk of falling.

Jaques-Dalcroze eurhythmics, an approach to music education through movement developed by the composer Emile Jaques-Dalcroze (1865-1960) in Geneva in the early 20th century, is currently practiced worldwide in the field of music, as well as dance, theatre and therapy. Initially intended for music students, Jaques-Dalcroze eurhythmics soon expanded extensively to music education of children and adolescents all over the world. The main focus of this method are on developing rhythmicality and musicality as well as strengthening body awareness, coordination, expression, as verbal and social skills. Recently, Jaques-Dalcroze eurhythmics classes for older adults were developed. Those classes engage the elderly in varied multitask exercises performed to the rhythm of improvised piano music, sometimes with the manipulation of objects (e.g., instruments of percussion, balls). Basic exercises consist of walking following the music, responding directly to changes in music's rhythmic patterns. In a cross-sectional study performed in long-term Jaques-Dalcroze eurhythmics users, the age-related increase of stride-to-stride variability appeared to be attenuated (Kressig, 2005). The effectiveness of this intervention to achieve improvement in gait variability in older adults without previous experience of Jaques-Dalcroze eurhythmics need to be confirmed prospectively.

Method

This randomized controlled trial was designed to assess the efficacy of a 6-month community-based Jaques-Dalcroze eurhythmics program in improving gait and balance, and reducing fall risk in elderly people with an increased risk of falling. The primary objective is to assess the efficacy of the intervention in reducing gait variability. Change in gait variability under dual-task condition over 6 months is the primary endpoint. The main secondary objectives are to assess the effects on other quantitative gait and balance measures, functional tests performances, and falls.

Volunteer participants are recruited in the Geneva area (Switzerland) through flyers, press releases and advertisements in local community newspapers. Individuals aged 65 or older, community-dwelling and identified at high risk for falling are randomly assigned, according to a computer-generated list, to either an immediate Jaques-Dalcroze eurhythmics program of weekly 1-hour classes for 6 months or a wait-list control group scheduled to receive the same intervention 6 months following the completion of the baseline assessment. Participants in the intervention group are followed for an additional 6 months in order to evaluate whether intervention gains can be maintained over time. Main outcome measures include gait (under single and dual-task conditions) and balance performances assessed by quantitative analysis (i.e., electronic walkway and angular velocity transducers) and functional tests administered at baseline, 6 and 12 months. Falls data are prospectively ascertained during the whole follow-up using a monthly calendar method with daily records. The principal analysis will be done on an intention to treat basis.

Following completion of the 12-month follow-up, subjects will have the option of continuing classes via the Jaques-Dalcroze Institute. Subjects will be invited to enter into an extension phase of the trial and participate in a follow-up assessment visit scheduled four years following original trial enrolment.

Conditions
Gait, Balance, Falls
Being tested
Music-based multitask exercises program
Keywords
Aged, Balance, Dual-task, Exercise, Falls, Gait, Music
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music-based multitask exercises programOther

    Also called Jaques-Dalcroze Eurhythmics

    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.

  • Music-based multitask exercises programOther

    Also called Jaques-Dalcroze Eurhythmics

    Subjects are wait-listed to receive, 6 months after randomization, the same 6-month Jaques-Dalcroze eurhythmics program as the Intervention group. They complete assessments at baseline, 6 and 12 months.

Study groups in NCT01107288
Study groupRoleWhat they receive
Intervention groupExperimentalRandomized to receive the intervention first
Receives: Other: Music-based multitask exercises program
Delayed intervention control groupOtherRandomized to wait-list control first
Receives: Other: Music-based multitask exercises program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in gait variability

    Measured: 6 months

Secondary outcomes (7)
  1. Change in other spatio-temporal gait parameters

    Measured: 6 months, 12 months

  2. Change in balance measures (Trunk sway parameters)

    Measured: 6 months, 12 months

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

    Measured: 6 months, 12 months

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

    Measured: 6 months, 12 months

  5. 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)

    Measured: 6 months, 12 months

  6. Change in gait variability

    Measured: 12 months

  7. Change in all outcome measures

    Long-term extension study

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2010 (estimated)
  2. Study startFeb 2008
  3. Primary completionDec 2009
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01107288
Sponsor's protocol ID
07-156
Status last verified
Feb 2014
First submitted
19 Apr 2010
Last updated
24 Feb 2014
Results posted
No
Data monitoring committee
No

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.

    PubMed 21098340

Questions about this trial

What is this clinical trial studying?

A study testing Music-based multitask exercises program in people with Gait and Balance, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in gait variability (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01107288, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.

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