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.
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
- 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
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.
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Randomized to receive the intervention first Receives: Other: Music-based multitask exercises program |
| Delayed intervention control group | Other | Randomized 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.
Change in gait variability
Measured: 6 months
Secondary outcomes (7)
Change in other spatio-temporal gait parameters
Measured: 6 months, 12 months
Change in balance measures (Trunk sway parameters)
Measured: 6 months, 12 months
Change in functional tests performances (Timed Up & Go test and simplified Tinetti test)
Measured: 6 months, 12 months
Number of falls, fallers and multiple fallers (Daily recording of falls using falls calendars, to be returned monthly)
Measured: 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)
Measured: 6 months, 12 months
Change in gait variability
Measured: 12 months
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.
- First posted20 Apr 2010 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Jaques-Dalcroze Institute, Geneva, Switzerland
- Responsible party
- Principal investigator, Andrea Trombetti, University Hospital, Geneva
- Investigators
- Andrea Trombetti, MD, Principal investigator, Bone Diseases Service, Department of Rehabilitation and Geriatrics, University Hospitals and Faculty of Medicine of Geneva
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Music-Based Multitask Exercises (Jaques-Dalcroze Eurhythmics) on Gait, Balance and Fall Risk in the Elderly
- ClinicalTrials.gov ID
- NCT01107288
- Acronym / sponsor ID
- 07-156
- Keywords
- Aged, Balance, Dual-task, Exercise, Falls, Gait, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Jaques-Dalcroze Institute, Geneva, Switzerland
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Music-based multitask exercises programRandomized to receive the intervention first |
| Delayed intervention control group | Other | Other: Music-based multitask exercises programRandomized to wait-list control first |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music-based multitask exercises programAlso: Jaques-Dalcroze EurhythmicsSubjects 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. | Other | Intervention group |
| Music-based multitask exercises programAlso: Jaques-Dalcroze EurhythmicsSubjects 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. | Other | Delayed intervention control group |
Primary outcome
Change in gait variability
Time frame: 6 months
7 secondary outcomes
Change in other spatio-temporal gait parameters
Time frame: 6 months, 12 months
Change in balance measures (Trunk sway parameters)
Time frame: 6 months, 12 months
Change in functional tests performances (Timed Up & Go test and simplified Tinetti test)
Time frame: 6 months, 12 months
Number of falls, fallers and multiple fallers (Daily recording of falls using falls calendars, to be returned monthly)
Time frame: 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)
Time frame: 6 months, 12 months
Change in gait variability
Time frame: 12 months
Change in all outcome measures
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
- Derived from this study: PubMed 21098340Trombetti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Trombetti, MD principal investigator
Bone Diseases Service, Department of Rehabilitation and Geriatrics, University Hospitals and Faculty of Medicine of Geneva
1 site in 1 country: see every site and its status.
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.