Clinical trial NCT01811745: Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors
Official title: Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors (EPHYCOS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Function
Cognitive Function
Falls
Keywords: Aged
Cognition
Exercise
Falls
Gait
Physical function
Dual-task
Music
Postural Balance
Randomized controlled trial
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 142
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in gait variability under dual-task condition
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: Change in gait performances (quantitative gait analysis under single and dual-task conditions)
timeFrame: 6 months, 12 months
measure: Change in balance performances (quantitative balance analysis)
timeFrame: 6 months, 12 months
measure: Change in functional tests performances (Timed Up & Go test and Short Physical Performance Battery)
timeFrame: 6 months, 12 months
measure: Incidence of falls and fractures (prospective daily recording using calendars, to be returned monthly)
timeFrame: 6 months, 12 months
measure: Change in cognitive performances (comprehensive neuropsychological battery assessing different aspects of executive functioning)
timeFrame: 6 months, 12 months
measure: Change in anxiety/depression (Hospital Anxiety and Depression scale)
timeFrame: 6 months, 12 months
measure: Change in fear of falling (Short-FESI)
timeFrame: 6 months, 12 months
Other outcomes:
measure: Change in brain networks (structural and functional levels)
timeFrame: 12 months
Locations:
city: Geneva
country: Switzerland
facility: Bone Diseases Service, Geneva University Hospitals
Study officials:
affiliation: Bone Diseases Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva
name: Andrea Trombetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.