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Morphological and Functional Biomarkers of Skeletal Muscle Adaptations in Sarcopenia

Study acronym: EXEDOS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Secondary endpoints revised (14)v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sarcopenia is an age-related condition characterized by progressive loss of skeletal muscle mass, muscle strength, and physical performance. It is associated with frailty, falls, disability, reduced independence, lower quality of life, and increased healthcare burden. Despite its clinical relevance, sarcopenia remains underdiagnosed, partly because current diagnostic approaches may be difficult to implement broadly in clinical practice and may not fully capture early changes in muscle quality and neuromuscular function. The EXEDOS study aims to evaluate an integrated diagnostic and therapeutic strategy for the early detection and management of sarcopenia. The study will assess Quantitative Ultrasound with Radio-Frequency analysis (QUS-RF) as a non-invasive, accessible, and radiation-free tool to characterize muscle morphology, microstructure, and quality. QUS-RF-derived parameters will be compared with established assessments, including body composition, muscle strength, physical performance, and imaging-based measures, to determine their feasibility, reliability, diagnostic accuracy, and responsiveness to change. The study also includes a 48-week randomized, parallel-group, open-label superiority trial designed to evaluate the effects of a digitally delivered home-based exercise intervention in older adults with sarcopenia or at risk of sarcopenia. Eligible participants will be randomized to either an experimental group receiving a structured home-based exercise program or a control group receiving general physical activity recommendations in line with current guidelines. The exercise program will combine progressive resistance and aerobic training and will be supported by a digital platform allowing remote monitoring, feedback, and supervision. All participants will receive general nutritional advice. Assessments will be performed at baseline, Week 12, and Week 48. The primary outcome of the randomized trial will be the change in 30-second Chair Stand Test performance, used as an indicator of lower-limb muscle function. Secondary outcomes will include handgrip strength, lower-limb maximal and explosive strength, walking capacity, balance, body composition, QUS-RF-derived muscle parameters, quality of life, mood, physical activity, dietary indicators, blood biomarkers, adherence to the intervention, and safety. A health economic analysis will also be conducted to estimate the potential cost-effectiveness and cost-utility of the proposed diagnostic and therapeutic strategy. By combining innovative muscle assessment with a scalable digitally supported exercise intervention, the EXEDOS study aims to improve early sarcopenia detection, personalize exercise prescription, and support the development of sustainable strategies to preserve muscle function and independence in older adults.
Trial Details
NCT Number NCT07692308
Lead Sponsor I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Collaborators: Universita di Verona
Conditions
(from sponsor)
Sarcopenia
Related terms Sarcopenia
Enrollment 192 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov