Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors

Cognitive Function Clinical Trial

— EPHYCOS  

Official title:

Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors (EPHYCOS Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811745
• Other study ID #: 12-175
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: October 31, 2016
• Start date: February 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognitive Function
• Falls
• Physical Function

Intervention

Behavioral:
• Jaques-Dalcroze eurhythmics training
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 training
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.

Locations

Country	Name	City	State
Switzerland	Bone Diseases Service, Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in brain networks (structural and functional levels)	fMRI sub-study	12 months	No
Primary	Change in gait variability under dual-task condition		6 months, 12 months	No
Secondary	Change in gait performances (quantitative gait analysis under single and dual-task conditions)		6 months, 12 months	No
Secondary	Change in balance performances (quantitative balance analysis)		6 months, 12 months	No
Secondary	Change in functional tests performances (Timed Up & Go test and Short Physical Performance Battery)		6 months, 12 months	No
Secondary	Incidence of falls and fractures (prospective daily recording using calendars, to be returned monthly)		6 months, 12 months	No
Secondary	Change in cognitive performances (comprehensive neuropsychological battery assessing different aspects of executive functioning)		6 months, 12 months	No
Secondary	Change in anxiety/depression (Hospital Anxiety and Depression scale)		6 months, 12 months	No
Secondary	Change in fear of falling (Short-FESI)		6 months, 12 months	No