RecruitingNot Applicable

Evaluation of Safety and Efficacy of a Digital Therapeutic Device to Improve Strength in Sarcopenia (Sarc-DTx)

South Korea130 participantsStarted 2025-11-28

Plain-language summary

This clinical trial aims to demonstrate that the use of a digital therapeutic device (exoDTx) in patients with sarcopenia is superior to self-exercise in terms of muscle strength improvement and safety.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Individuals diagnosed with sarcopenia according to both the European Working Group on Sarcopenia in Older People (EWGSOP) criteria and the Asian Working Group for Sarcopenia 2019 (AWGS 2019) criteria * Individuals with reduced muscle strength, defined as at least one of the following: * Handgrip strength \< 28 kg for men or \< 18 kg for women * Five-times Sit-to-Stand Test time \> 12 seconds without arm support * Individuals with reduced muscle mass, defined as at least one of the following: * Skeletal Muscle Mass Index (SMI) \< 7.0 kg/m² for men or \< 5.4 kg/m² for women measured by DXA * Skeletal Muscle Mass Index (SMI) \< 7.0 kg/m² for men or \< 5.7 kg/m² for women measured by BIA * Individuals able to independently perform sit-to-stand movements * Individuals with sufficient physical and cognitive capacity to participate in the exercise program * Individuals able and willing to provide written informed consent * Individuals able to operate a mobile phone independently or with assistance from a caregiver Exclusion Criteria * Individuals with cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \< 20, or those unable to participate due to cognitive decline * Individuals with an implanted cardiac pacemaker or other implanted electronic medical device * Individuals with uncontrolled cardiovascular disease despite appropriate medical management * Individuals who have undergone lower-limb surgery within the past 6 months and are …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in peak knee extension strength (Nm) from baseline to 12 weeks

Timeframe: 12 weeks after Visit 1 (treatment initiation)

Trial details

NCT IDNCT07319377

SponsorExosystems

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Sangui Choi, CPO

+82-10-3028-7759 tkddml30@exosystems.io

View on ClinicalTrials.gov More Sarcopenia trials

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.