exoDTx digital therapeutic to boost muscle strength in sarcopenia
A Multicenter, Prospective, Randomized, Parallel-Group, Double-blinded, Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of a Digital Therapeutic Device for Improving Muscle Strength in Patients With Sarcopenia
This tests whether using the exoDTx digital therapeutic device helps people with sarcopenia gain more muscle strength than following self-guided exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Exosystems Industry-sponsored |
| Locations | 2 sites (Bucheon-si and 1 other locations) |
| Trial ID | NCT07319377 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares a personalized digital therapeutic device (exoDTx) to self-directed exercise using educational materials in adults diagnosed with sarcopenia. Participants must meet EWGSOP and AWGS criteria for low muscle mass and strength and be able to perform sit-to-stand movements and operate a mobile phone. The exoDTx provides guided resistance exercises with automatic intensity adjustments, recording, and remote monitoring, while the comparator group receives standard self-exercise guidance. Primary outcomes focus on changes in muscle strength and safety events, with additional measures of physical function and adherence.
Who should consider this trial
Good fit: Adults diagnosed with sarcopenia per EWGSOP and AWGS criteria who have reduced muscle mass and strength, can perform sit-to-stand movements, and can operate a mobile phone (with caregiver help if needed).
Not a fit: Patients with significant cognitive impairment (e.g., MMSE <20), inability to perform required movements, or who cannot use a mobile phone or follow the program are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the device could help patients build more muscle strength and improve physical function by delivering personalized, guided exercise with better adherence than self-directed programs.
How similar studies have performed: Small pilot studies and digital exercise programs have shown promise for improving strength and adherence, but large randomized trials of DTx for sarcopenia remain limited, so this approach is relatively novel yet plausible.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of sarcopenia according to both the European Working Group on Sarcopenia in Older People (EWGSOP) and the 2019 Asian Working Group for Sarcopenia (AWGS) criteria * Evidence of reduced muscle strength, defined as handgrip strength \< 28 kg for men or \< 18 kg for women, or a five-times sit-to-stand test time \> 12 seconds without arm support * Evidence of reduced muscle mass, defined as a skeletal muscle mass index \< 7.0 kg/m² for men or \< 5.4 kg/m² for women measured by DXA, or \< 7.0 kg/m² for men or \< 5.7 kg/m² for women measured by BIA * Ability to independently perform sit-to-stand movements * Sufficient physical and cognitive ability to participate in the exercise program * Ability to provide written informed consent * Ability to operate a mobile phone independently or with assistance from a caregiver Exclusion Criteria: * Cognitive impairment defined as a Mini-Mental State Examination score \< 20 or inability to participate due to cognitive decline * Presence of an implanted cardiac pacemaker * Uncontrolled cardiovascular disease despite appropriate medical treatment * Lower limb surgery within the past 6 months resulting in inability to walk independently * Moderate to severe musculoskeletal pain or functional limitations that interfere with objective functional assessments * Severe obesity defined as a body mass index \> 50 kg/m² * Active cancer treatment or severe systemic frailty * Hemiplegia resulting in inability to perform the prescribed exercise program * Anticipated inability to complete the study protocol as determined by the investigator * Inability to comply with study instructions delivered in Korean
Where this trial is running
Bucheon-si and 1 other locations
- Bucheon St. Mary's Hospital — Bucheon-si, South Korea (Recruiting)
- St.Vincent's hospital — Suwon, South Korea (Recruiting)
Study contacts
- Principal investigator: Sangui Choi, CPO — Exosystems
- Study coordinator: Sangui Choi, CPO
- Email: tkddml30@exosystems.io
- Phone: +82-10-3028-7759
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.