SarcopeniaEXEDOSNCT07692308
Morphological and Functional Biomarkers of Skeletal Muscle Adaptations in Sarcopenia
A study testing Digitally delivered home-based exercise intervention and General physical activity recommendations in people with Sarcopenia, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Digitally delivered home-based exercise intervention and General physical activity recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2026to 3 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Healthy age-, sex-, and physical activity-matched older adults eligible for inclusion in the reference cohort.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stefano Borghi, Ph.D. contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Mi, 20157
Stefano Borghi, Ph.D., +390283502246, stefano.borghi@grupposandonato.it
About this study
Official title: Morphological and Functional Biomarkers of Skeletal Muscle Adaptations for Early Detection of Sarcopenia and of the Therapeutic Effects of a Home-Based Exercise Intervention: A Randomized-Controlled Trial
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.
Read more
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.
- Conditions
- Sarcopenia
- Being tested
- Digitally delivered home-based exercise intervention, General physical activity recommendations
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally delivered home-based exercise interventionBehavioural
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.
General physical activity recommendationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenia - Exercise Intervention | Experimental | 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. Receives: Behavioral: Digitally delivered home-based exercise intervention |
| Sarcopenia - Control | Active comparator | 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. Receives: Behavioral: General physical activity recommendations |
| Pre-sarcopenia - Exercise Intervention | Experimental | 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. Receives: Behavioral: Digitally delivered home-based exercise intervention |
| Pre-sarcopenia - Control | Active comparator | 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. Receives: Behavioral: General physical activity recommendations |
| Healthy Reference Cohort | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12, and Week 48
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, and Week 48
Change in fat mass assessed by bioelectrical impedance analysis
Baseline, Week 12, and Week 48
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start3 Jun 2026
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692308
- Sponsor's protocol ID
- GR-2024-12378411
- Acronym
- EXEDOS
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Functional Biomarkers of Skeletal Muscle Adaptations for Early Detection of Sarcopenia and of the Therapeutic Effects of a Home-Based Exercise Intervention: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT07692308
- Acronym / sponsor ID
- EXEDOS / GR-2024-12378411
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Jun 2029 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sarcopenia - Exercise Intervention | Experimental | Behavioral: Digitally delivered home-based exercise interventionParticipants 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 comparator | Behavioral: General physical activity recommendationsParticipants 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 | Experimental | Behavioral: Digitally delivered home-based exercise interventionParticipants 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 comparator | Behavioral: General physical activity recommendationsParticipants 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 intervention | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Healthy age-, sex-, and physical activity-matched older adults eligible for inclusion in the reference cohort.
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digitally delivered home-based exercise interventionDigitally 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. | Behavioural | Pre-sarcopenia - Exercise Intervention, Sarcopenia - Exercise Intervention |
| General physical activity recommendationsParticipants 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. | Behavioural | Pre-sarcopenia - Control, Sarcopenia - Control |
Primary outcome
Change in 30-second Chair Stand Test performance
Time frame: Baseline, Week 12, and Week 48
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.
14 secondary outcomes
Change in handgrip strength
Time frame: Baseline, Week 12, and Week 48
Change in lower-limb explosive strength
Time frame: Baseline, Week 12, and Week 48
Change in 6-Minute Walk Test distance
Time frame: Baseline, Week 12, and Week 48
Change in Mini-Balance Evaluation Systems Test score
Time frame: Baseline, Week 12, and Week 48
Change in fat mass assessed by bioelectrical impedance analysis
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
Time frame: Baseline, Week 12, and Week 48
Change in skeletal muscle mass index assessed by bioelectrical impedance analysis
Time frame: Baseline, Week 12, and Week 48
Change in appendicular skeletal muscle mass index assessed by dual-energy X-ray absorptiometry
Time frame: Baseline and Week 48
Change in quantitative ultrasound radio-frequency-derived muscle echo-intensity parameters
Time frame: Baseline, Week 12, and Week 48
Area under the receiver operating characteristic curve of quantitative ultrasound radio-frequency analysis for sarcopenia classification
Time frame: Baseline
Change in 12-Item Short Form Health Survey Physical Component Summary score
Time frame: Baseline, Week 12, and Week 48
Change in 12-Item Short Form Health Survey Mental Component Summary score
Time frame: Baseline, Week 12, and Week 48
Change in Profile of Mood States Total Mood Disturbance score
Time frame: Baseline, Week 12, and Week 48
Change in C-reactive protein concentration
Time frame: Baseline and Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Borghi, Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitally delivered home-based exercise intervention and General physical activity recommendations in people with Sarcopenia, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Bonato, Ph.D. (+390283502246, matteo.bonato@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 30-second Chair Stand Test performance (time frame: Baseline, Week 12, and Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.