Recruiting

EXEDOSQUS-RF Muscle Assessment and Home-Based Exercise for Sarcopenia Management

Study Aim

This study aims to evaluate the improvement in lower-limb muscle function through a 30-second Chair Stand Test, after participating in a home-based exercise program for sarcopenia management.

What is being tested

Digitally delivered home-based exercise intervention

+ General physical activity recommendations

+ Digitally delivered home-based exercise intervention

Behavioral

Who is being recruted

Atrophy+6

+ Muscular Atrophy

+ Nervous System Diseases

Over 50 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2026

See protocol details

Summary

Principal SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study ContactMatteo Bonato, Ph.D.More contacts

Last updated: July 9, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 3, 2026

Actual date on which the first participant was enrolled.

Sarcopenia is a condition that often comes with age, causing a gradual loss of muscle mass, strength, and physical performance. It's linked to various issues like frailty, falls, reduced independence, and lower quality of life. The EXEDOS study is working on a new approach to detect and manage sarcopenia early. This research focuses on older adults who either have sarcopenia or are at risk of developing it. The goal is to improve the detection of sarcopenia and find effective ways to maintain muscle function and independence in older adults. The study involves a 48-week program where participants are divided into two groups. One group follows a structured home-based exercise program that combines resistance and aerobic training, supported by a digital platform for monitoring and feedback. The other group receives general physical activity advice according to current guidelines. All participants also get general nutritional advice. The effects of this program are measured at the start, after 12 weeks, and after 48 weeks. The main outcome measured is the change in the 30-second Chair Stand Test performance, which indicates lower-limb muscle function. Other outcomes include handgrip strength, walking capacity, balance, body composition, muscle quality, quality of life, mood, physical activity, dietary indicators, blood biomarkers, adherence to the intervention, and safety.

NCT07692308

Principal SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study ContactMatteo Bonato, Ph.D.More contacts

Last updated: July 9, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

192 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AtrophyMuscular AtrophyNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalNeuromuscular ManifestationsSarcopenia

Criteria

5 inclusion criteria required to participate

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

Sedentary individuals aged over 50 years

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

Show More Criteria

6 exclusion criteria prevent from participating

Substance or alcohol abuse

Inability to complete the exercise protocol

Hospitalization within the previous 6 weeks

Major locomotor impairments

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Group IV

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.

Group 5

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, ItalyOpen IRCCS Ospedale Galeazzi-Sant'Ambrogio in Google Maps

Recruiting

One Study Center