Sarcopenia and exercise in seniors

• Register: ISRCTN
• Last refreshed on: 5 August 2022
• Main ID: ISRCTN39600964
• Date of registration: 01/06/2017
• Prospective Registration: Yes
• Primary sponsor: Geneva University Hospitals
• Public title: Sarcopenia and exercise in seniors
• Scientific title: SARCopeniA and exeRcisE in older adults: a randomized controlled trial
• Date of first enrolment: 01/06/2017
• Target sample size: 196
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN39600964
• Study type: Interventional
• Study design: Prospective single-centre single-blind two-arm randomized controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Switzerland

Contacts

• Name: Andrea Trombetti

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age =65 years (no upper age limit)
2. Short Physical Performance Battery (SPPB) score between 3 and 9, inclusive
3. Presence of low muscle mass according to the Baumgartner definition
4. Able to complete the 400 m walk test within 15 minutes without sitting or the help of another person, or the use of a walker
5. Willingness to give informed consent, to be randomized to one of the two study groups, and comply with all study requirements
Exclusion criteria: People are excluded from participation in the study for any condition likely to affect the safety of the intervention and/or limit lifespan, or factors that may limit adherence to intervention or affect conduct of the trial (e.g., physical limitations should not be clearly attributable to the direct effect of a specific disease). In particular, exclusion criteria applied are:
1. Resides in a nursing home or is hospitalized
2. Diagnosis of dementia or score <21 on the MMSE
3. Serious neurological, neuromuscular or orthopaedic condition (e.g.,Parkinson's disease)
4. Serious cardiovascular or pulmonary condition (including myocardial infarction in previous 6 months) or development of chest pain or severe shortness of breath on the 400 m walk test
5. Participation in a supervised music-based multitask exercise program in the past 12 months

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Sarcopenia
Musculoskeletal Diseases

Intervention(s)

Participants will be randomized according to a computer-generated randomization sequence in a 1:1 ratio to either:
1. The music-based multitask exercise intervention (i.e., Jaques-Dalcroze Eurhythmics), which will consist of supervised, structured, progressive, twice-weekly, 60-min sessions for 12 months
2. The control group, who will not receive the music-based multitask exercise intervention during the study period
Participants from both study groups will also attend quarterly workshops regarding health-related issues (i.e., 4 workshops over 12 months; 60-min duration).

All subjects are followed-up for 12 months from randomization and asked to attend three clinical visits in addition to the screening visit (i.e., at baseline, 6 months and 12 months). Clinical visits include assessment of physical performance, skeletal muscle health, sarcopenia status, cognitive performances, incidence of falls and injurious falls, mobility disability, and quality of life. In addition, brain and neuromuscular function are specifically addressed among a subgroup of trial participants (i.e., exploratory sub-study), which, in particular, involves functional magnetic resonance imaging (fMRI) at baseline and 12 months.

Primary Outcome(s)

Physical performance, measured with the Short Physical Performance Battery (SPPB) score at baseline, 6 and 12 months

Secondary Outcome(s)

1. Skeletal muscle health (including muscle strength and muscle mass, assessed by dynamometry and dual-energy X-ray absorptiometry, respectively) at baseline, 6 and 12 months
2. Sarcopenia status according to cut-off points for sarcopenia at baseline, 6 and 12 months
3. Other physical performances (including gait speed, five times sit-to-stand test time and Timed Up & Go tests) at baseline, 6 and 12 months
4. Balance (including simplified Tinetti test) measured at baseline, 6 and 12 months
5. Cognitive performance, measured with a comprehensive neuropsychological battery assessing different aspects of executive functioning at baseline, 6 and 12 months
6. Incidence of falls and injurious falls, measured with prospective daily recording using calendars at baseline, 6 and 12 months
7. Mobility disability (including 400m walk test) at baseline, 6 and 12 months
8. Quality of life (including SF-36, SarQol) at baseline, 6 and 12 months

Secondary ID(s)

CCER2017-00437

Source(s) of Monetary Support

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (Ref: 32003B_166690)

Ethics review

Status:
Approval date:
Contact:

Cantonal Ethics Committee Geneva (Commission cantonale d'Ethique de la Recherche du Canton de Genève), 21/03/2017, ref: 2017-00437

Results

• Results available: Yes
• Date Completed: 31/03/2020