An interventional study of Digitally delivered home-based exercise intervention and General physical activity recommendations in Sarcopenia, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Recruiting at 1 site in Italy. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Not applicable, Interventional, and Treatment
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.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 192 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Behavioral: Digitally delivered home-based exercise intervention
Participants 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.
Behavioral: General physical activity recommendations
Participants 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.
Behavioral: Digitally delivered home-based exercise intervention
Participants 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.
Behavioral: General physical activity recommendations
Healthy 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.
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.
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.
Time frame: Baseline, Week 12, and Week 48
Change in handgrip strength
Maximal handgrip strength will be assessed using a handgrip dynamometer according to a standardized protocol. The outcome will be expressed in kilograms or Newtons, according to the device output. Changes from baseline to Week 12 and Week 48 will be compared between groups.
Time frame: Baseline, Week 12, and Week 48
Change in lower-limb explosive strength
Explosive strength and rapid force production will be assessed during lower-limb contractions using standardized dynamometric procedures. The outcome will quantify the ability to rapidly generate force and will be used to characterize neuromuscular adaptations to the intervention.
Time frame: Baseline, Week 12, and Week 48
Change in 6-Minute Walk Test distance
Functional walking capacity will be assessed using the 6-Minute Walk Test. Participants will be instructed to walk as far as possible in 6 minutes according to a standardized protocol. The outcome will be expressed as distance walked in meters.
Time frame: Baseline, Week 12, and Week 48
Change in Mini-Balance Evaluation Systems Test score
Balance performance will be assessed using the Mini-Balance Evaluation Systems Test. The total score ranges from 0 to 28 points, with higher scores indicating better balance performance. Changes from baseline to Week 12 and Week 48 will be evaluated to assess intervention-related effects on balance.
Time frame: Baseline, Week 12, and Week 48
Change in fat mass assessed by bioelectrical impedance analysis
Baseline, Week 12, and Week 48
Time frame: 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.
Change in lean mass assessed by bioelectrical impedance analysis
Lean 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.
Time frame: Baseline, Week 12, and Week 48
Change in skeletal muscle mass index assessed by bioelectrical impedance analysis
Skeletal muscle mass index will be assessed using bioelectrical impedance analysis according to standardized procedures. The outcome will be expressed as kilograms per square meter. Changes from baseline to Week 12 and Week 48 will be evaluated.
Time frame: Baseline, Week 12, and Week 48
Change in appendicular skeletal muscle mass index assessed by dual-energy X-ray absorptiometry
Appendicular skeletal muscle mass index will be assessed using dual-energy X-ray absorptiometry. The index will be calculated as appendicular skeletal muscle mass divided by height squared and expressed in kilograms per square meter. This is a continuous body composition parameter, not a scale score; therefore, no fixed minimum or maximum values apply. Higher values indicate greater appendicular skeletal muscle mass relative to height.
Time frame: Baseline and Week 48
Change in quantitative ultrasound radio-frequency-derived muscle echo-intensity parameters
Quantitative ultrasound radio-frequency analysis will be used to assess muscle quality and microstructure. The primary QUS-RF parameter will be muscle echo-intensity, derived from standardized ultrasound acquisitions of selected lower-limb muscles. The outcome will be expressed in arbitrary units or grayscale units, according to the image analysis output. Changes from baseline to Week 12 and Week 48 will be evaluated and related to functional outcomes.
Time frame: Baseline, Week 12, and Week 48
Area under the receiver operating characteristic curve of quantitative ultrasound radio-frequency analysis for sarcopenia classification
The diagnostic performance of quantitative ultrasound radio-frequency-derived muscle parameters for classifying sarcopenia status will be evaluated against reference criteria based on muscle mass and muscle strength. Diagnostic accuracy will be expressed as the area under the receiver operating characteristic curve. The area under the receiver operating characteristic curve ranges from 0.5 to 1.0 for a clinically useful classifier, with higher values indicating better diagnostic accuracy.
Time frame: Baseline
Change in 12-Item Short Form Health Survey Physical Component Summary score
Health-related physical quality of life will be assessed using the 12-Item Short Form Health Survey Physical Component Summary score. The score ranges from 0 to 100, with higher scores indicating better physical health-related quality of life. Changes from baseline to Week 12 and Week 48 will be evaluated between groups.
Time frame: Baseline, Week 12, and Week 48
Change in 12-Item Short Form Health Survey Mental Component Summary score
Health-related mental quality of life will be assessed using the 12-Item Short Form Health Survey Mental Component Summary score. The score ranges from 0 to 100, with higher scores indicating better mental health-related quality of life. Changes from baseline to Week 12 and Week 48 will be evaluated between groups.
Time frame: Baseline, Week 12, and Week 48
Change in Profile of Mood States Total Mood Disturbance score
Mood state will be assessed using the Profile of Mood States questionnaire. The Total Mood Disturbance score will be calculated according to standard scoring procedures. Higher scores indicate greater mood disturbance and therefore a worse mood-related outcome. Changes from baseline to Week 12 and Week 48 will be evaluated between groups.
Time frame: Baseline, Week 12, and Week 48
Change in C-reactive protein concentration
Systemic inflammation will be assessed by measuring serum C-reactive protein concentration. The outcome will be expressed in milligrams per liter. Changes from baseline to Week 48 will be evaluated between groups.
Time frame: Baseline and Week 48
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