Morphological and Functional Biomarkers of Skeletal Muscle Adaptations in Sarcopenia
EXEDOS
1 other identifier
interventional
192
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2026
CompletedFirst Submitted
Initial submission to the registry
June 26, 2026
CompletedFirst Posted
Study publicly available on registry
July 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 3, 2029
July 13, 2026
July 1, 2026
1 year
June 26, 2026
July 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in 30-second Chair Stand Test performance
Lower-limb muscle function will be assessed using the 30-second Chair Stand Test. Participants will be asked to complete as many sit-to-stand repetitions as possible within 30 seconds using a standardized protocol. The outcome will be expressed as the number of complete repetitions. The primary analysis will evaluate changes from baseline to Week 12 and Week 48 between the exercise intervention and control groups.
Baseline, Week 12, and Week 48
Secondary Outcomes (14)
Change in handgrip strength
Baseline, Week 12, and Week 48
Change in lower-limb explosive strength
Baseline, Week 12, and Week 48
Change in 6-Minute Walk Test distance
Baseline, Week 12, and Week 48
Change in Mini-Balance Evaluation Systems Test score
Baseline, Week 12, and Week 48
Change in fat mass assessed by bioelectrical impedance analysis
Fat mass will be assessed using bioelectrical impedance analysis according to standardized procedures. The outcome will be expressed in percentage. Changes from baseline to Week 12 and Week 48 will be evaluated.
- +9 more secondary outcomes
Study Arms (5)
Sarcopenia - Exercise Intervention
EXPERIMENTALParticipants with sarcopenia allocated to the exercise group will receive a 48-week digitally delivered home-based exercise intervention. The program will include progressive resistance exercises using body weight and/or light external loads, combined with moderate-intensity aerobic training. Sessions will be performed three times per week for approximately 45 minutes per session. The intervention will be supported by a digital platform, wearable inertial sensors, heart-rate monitoring, instructional videos, automated feedback, and remote professional supervision. Participants will also receive general nutritional advice.
Sarcopenia - Control
ACTIVE COMPARATORParticipants with sarcopenia allocated to the control group will receive general physical activity recommendations in line with current WHO guidelines and general nutritional advice. They will not receive the digitally delivered individualized exercise intervention. Participants will undergo the same assessment schedule as the intervention group, including baseline, Week 12, and Week 48 evaluations of muscle strength, physical performance, balance, body composition, QUS-RF-derived muscle parameters, questionnaires, dietary monitoring, and blood biomarkers, according to the study protocol.
Pre-sarcopenia - Exercise Intervention
EXPERIMENTALParticipants at risk of sarcopenia, defined by reduced muscle mass with preserved muscle strength, allocated to the exercise group will receive a 48-week digitally delivered home-based exercise intervention. The program will combine progressive resistance training using body weight and/or light external loads with moderate-intensity aerobic training. Sessions will be performed three times per week for approximately 45 minutes per session. Training will be monitored through a digital platform including wearable inertial sensors, heart-rate monitoring, instructional videos, automated feedback, and remote professional supervision. Participants will also receive general nutritional advice.
Pre-sarcopenia - Control
ACTIVE COMPARATORParticipants at risk of sarcopenia, defined by reduced muscle mass with preserved muscle strength, allocated to the control group will receive general physical activity recommendations in line with current WHO guidelines and general nutritional advice. They will not receive the digitally delivered individualized exercise intervention. Participants will complete the same assessment schedule as the intervention group, including baseline, Week 12, and Week 48 evaluations of muscle strength, physical performance, balance, body composition, QUS-RF-derived muscle parameters, questionnaires, dietary monitoring, and blood biomarkers.
Healthy Reference Cohort
NO INTERVENTIONHealthy age-, sex-, and physical activity-matched older adults will be included as a non-randomized reference cohort. These participants will not receive the digitally delivered exercise intervention and will not be assigned to the control condition. They will undergo the scheduled study assessments to provide reference values for diagnostic and longitudinal comparisons, including evaluations of body composition, QUS-RF-derived muscle parameters, muscle strength, physical performance, balance, questionnaires, dietary monitoring, and blood biomarkers at the planned study time points.
Interventions
Digitally delivered, home-based, 48-week exercise program combining progressive resistance training and moderate-intensity aerobic training. Participants will perform three sessions per week, each lasting approximately 45 minutes. Resistance exercises will use body weight and/or light external loads and will follow progressive overload principles. Aerobic exercise intensity will be adjusted using heart-rate feedback. The intervention will be delivered through a certified digital therapeutic platform including instructional videos, wearable inertial sensors, heart-rate monitoring, automated feedback, and remote professional supervision through chat or video call. Training progression will be individualized using adherence data, functional assessments, and monitoring outputs.
Participants allocated to the control condition will receive general physical activity recommendations in line with current WHO guidelines and general nutritional advice. They will not receive the digitally delivered individualized exercise program, wearable sensor-based monitoring, automated feedback, or remote exercise supervision. This intervention is intended to represent a standard recommendation-based comparator condition against which the digitally delivered home-based exercise intervention will be evaluated.
Eligibility Criteria
You may qualify if:
- Sedentary individuals aged over 50 years.
- Individuals with sarcopenia, defined as reduced muscle mass assessed by bioelectrical impedance analysis and reduced muscle strength assessed by handgrip strength, according to EWGSOP2 criteria.
- Individuals at risk of sarcopenia, defined as reduced muscle mass with preserved muscle strength.
- Ability to understand the study procedures and provide written informed consent.
You may not qualify if:
- Hospitalization within the previous 6 weeks.
- Substance or alcohol abuse.
- Use of medications that may impair balance or coordination.
- Major locomotor impairments.
- Inability to complete the exercise protocol.
- Medical, cognitive, or functional conditions that, in the opinion of the investigators, may interfere with safe participation, adherence to the study procedures, or completion of the follow-up assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universita di Veronacollaborator
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogiolead
Study Sites (1)
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Mi, 20157, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2026
First Posted
July 9, 2026
Study Start
June 3, 2026
Primary Completion (Estimated)
June 3, 2027
Study Completion (Estimated)
June 3, 2029
Last Updated
July 13, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share