exoDTx: 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).
Self-exercise (Educational Material): 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).
Study 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
Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
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 unable to ambulate independently
* Individuals with moderate-to-severe musculoskeletal pain or functional limitations that interfere with objective functional assessments
* Individuals with severe obesity, defined as a body mass index (BMI) \> 50 kg/m²
* Individuals currently receiving active cancer treatment or experiencing severe systemic frailty
* Individuals with hemiplegia that prevents participation in the prescribed exercise program
* Individuals who are anticipated by the investigator to be unable to complete the study procedures or follow-up assessments
* Individuals unable to understand or comply with study instructions provided in Korean
* Individuals considered unsuitable for study participation at the discretion of the investigator for any other reason
Primary outcome measure(s)
Change in peak knee extension strength (Nm) from baseline to 12 weeks — 12 weeks after Visit 1 (treatment initiation) Between-group comparison of mean change in knee extensor strength measured by lower extremity dynamometer.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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