Physical FunctionEPHYCOSNCT01811745
Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors
A study testing Jaques-Dalcroze eurhythmics training and Multicomponent exercise training in people with Physical Function and Cognitive Function, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Physical Function, Cognitive Function, Falls
- What is being tested?
- Jaques-Dalcroze eurhythmics training and Multicomponent exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to May 2015
- 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 (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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bone Diseases Service, Geneva University Hospitals
Geneva, 1211
About this study
Official title: Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors (EPHYCOS Study)
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
- Being tested
- Jaques-Dalcroze eurhythmics training, Multicomponent exercise training
- Keywords
- Aged, Cognition, Exercise, Falls, Gait, Physical function, Dual-task, Music, Postural Balance, Randomized controlled trial
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaques-Dalcroze eurhythmics trainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Jaques-Dalcroze eurhythmics training | Experimental | Once-weekly 60-min Jaques-Dalcroze eurhythmics class, for 12 months. Receives: 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. Receives: Behavioral: Multicomponent exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait variability under dual-task condition
Measured: 6 months, 12 months
Secondary outcomes (7)
Change in gait performances (quantitative gait analysis under single and dual-task conditions)
Measured: 6 months, 12 months
Change in balance performances (quantitative balance analysis)
Measured: 6 months, 12 months
Change in functional tests performances (Timed Up & Go test and Short Physical Performance Battery)
Measured: 6 months, 12 months
Incidence of falls and fractures (prospective daily recording using calendars, to be returned monthly)
Measured: 6 months, 12 months
Change in cognitive performances (comprehensive neuropsychological battery assessing different aspects of executive functioning)
Measured: 6 months, 12 months
Change in anxiety/depression (Hospital Anxiety and Depression scale)
Measured: 6 months, 12 months
Change in fear of falling (Short-FESI)
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2015
- Study completionMay 2015
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 Physical FunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Trombetti, University Hospital, Geneva
- Investigators
- Andrea Trombetti, MD, Principal investigator, Bone Diseases Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811745
- Sponsor's protocol ID
- 12-175
- Acronym
- EPHYCOS
- Status last verified
- Oct 2016
- First submitted
- 12 Mar 2013
- Last updated
- 1 Nov 2016
- 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 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors (EPHYCOS Study)
- ClinicalTrials.gov ID
- NCT01811745
- Acronym / sponsor ID
- EPHYCOS / 12-175
- Conditions
- Physical Function, Cognitive Function, Falls
- Keywords
- Aged, Cognition, Exercise, Falls, Gait, Physical function, Dual-task, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Mar 2013 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jaques-Dalcroze eurhythmics training | Experimental | Behavioral: Jaques-Dalcroze eurhythmics trainingOnce-weekly 60-min Jaques-Dalcroze eurhythmics class, for 12 months. |
| Multicomponent exercise training | Active comparator | Behavioral: Multicomponent exercise trainingOnce-weekly 60-min multicomponent exercise class supplemented by one 30-min home-based exercise session, for 12 months. |
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 (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
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Jaques-Dalcroze eurhythmics training12 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. | Behavioural | Jaques-Dalcroze eurhythmics training |
| Multicomponent exercise training12 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. | Behavioural | Multicomponent exercise training |
Primary outcome
Change in gait variability under dual-task condition
Time frame: 6 months, 12 months
7 secondary outcomes
Change in gait performances (quantitative gait analysis under single and dual-task conditions)
Time frame: 6 months, 12 months
Change in balance performances (quantitative balance analysis)
Time frame: 6 months, 12 months
Change in functional tests performances (Timed Up & Go test and Short Physical Performance Battery)
Time frame: 6 months, 12 months
Incidence of falls and fractures (prospective daily recording using calendars, to be returned monthly)
Time frame: 6 months, 12 months
Change in cognitive performances (comprehensive neuropsychological battery assessing different aspects of executive functioning)
Time frame: 6 months, 12 months
Change in anxiety/depression (Hospital Anxiety and Depression scale)
Time frame: 6 months, 12 months
Change in fear of falling (Short-FESI)
Time frame: 6 months, 12 months
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 1 Nov 2016.
- Background: 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 Bone Diseases Service, Department of Internal Medicine Specialties, 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 Jaques-Dalcroze eurhythmics training and Multicomponent exercise training in people with Physical Function and Cognitive Function, 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 5 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 1 Nov 2016. 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 under dual-task condition (time frame: 6 months, 12 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 NCT01811745, 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 1 Nov 2016.