Actively Recruiting
Evaluation of Safety and Efficacy of a Digital Therapeutic Device to Improve Strength in Sarcopenia (Sarc-DTx)
Led by Exosystems · Updated on 2026-05-12
130
Participants Needed
2
Research Sites
43 weeks
Total Duration
On this page
Sponsors
E
Exosystems
Lead Sponsor
T
The Catholic University of Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Safety and Efficacy of a Digital Therapeutic Device to Improve Strength in Sarcopenia (Sarc-DTx)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of sarcopenia according to both EWGSOP and 2019 AWGS criteria
- Reduced muscle strength: handgrip < 28 kg for men or < 18 kg for women, or five-times sit-to-stand test time > 12 seconds without arm support
- Reduced muscle mass: skeletal muscle mass index < 7.0 kg/m² for men or < 5.4 kg/m² for women by DXA, or < 7.0 kg/m² for men or < 5.7 kg/m² for women by BIA
- Ability to perform sit-to-stand movements independently
- Sufficient physical and cognitive ability to take part in the exercise program
- Ability to provide written informed consent
- Ability to operate a mobile phone independently or with caregiver assistance
You will not qualify if you...
- Cognitive impairment with Mini-Mental State Examination score < 20 or inability to participate due to cognitive decline
- Presence of an implanted cardiac pacemaker
- Uncontrolled cardiovascular disease despite treatment
- Lower limb surgery within the past 6 months causing inability to walk independently
- Moderate to severe musculoskeletal pain or limitations affecting functional assessments
- Severe obesity with body mass index > 50 kg/m²
- Active cancer treatment or severe systemic frailty
- Hemiplegia causing inability to perform the exercise program
- Anticipated inability to complete the study protocol
- Inability to follow study instructions delivered in Korean
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Bucheon St. Mary's Hospital
Bucheon-si, South Korea
Actively Recruiting
2
St.Vincent's hospital
Suwon, South Korea
Actively Recruiting
Research Team
S
Sangui Choi, CPO
CONTACT
E
Eun Ji Lee, AP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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