Evaluation of Safety and Efficacy of a Digital Therapeutic Device to Improve Strength in Sarcopenia (Sarc-DTx)
A Multicenter, Prospective, Randomized, Parallel-Group, Assessor-blinded, Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of a Digital Therapeutic Device for Improving Muscle Strength in Patients With Sarcopenia
Exosystems
130 participants
Nov 28, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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
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Interventions
Experimental group (exoDTx): After baseline on-site training, participants perform personalized resistance exercises at home using a mobile app ≥3 times/week, 50 min/session, for 12 weeks (≥150 min/week). The program provides grip strength-based automatic intensity adjustment, exercise recording, feedback, and physician monitoring. Delivery: Nonpharmacological, non-invasive, home-based exercise program. The experimental group uses a mobile app; the control group uses educational materials. Initial instruction occurs on-site. Visits \& Monitoring: Screening/Baseline (week 0), In-treatment (weeks 4, 8), Post-treatment (week 12), and Follow-up (week 24).
Control group (Self-exercise): No app is used. Participants perform the same exercise guided by QR code-based educational materials, ≥3 times/week, 50min/session, for 12 weeks, maintaining exercise logs without automatic adjustment or remote monitoring. Delivery: Non-pharmacological, non-invasive, homebased exercise program. The experimental group uses a mobile app; the control group uses educational materials. Initial instruction occurs on-site. Visits \& Monitoring: Screening/Baseline (week 0), In-treatment (weeks 4, 8), Post-treatment (week 12), and Follow-up (week 24).
Locations(3)
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NCT07319377