Overview
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.
Description
Background Sarcopenia is a condition characterized by progressive loss of skeletal muscle mass and strength, which is closely associated with functional decline, falls, and increased mortality.Conventional first-line treatment involves resistance training; however, in older adults, low adherence and practical challenges often limit its effectiveness.Recently, digital therapeutics (DTx) have emerged as promising tools by providing personalized exercise programs, automatic adjustment of intensity, and integrated recording and monitoring functions. These features are expected to overcome the limitations of selfdirected exercise.Therefore, this study seeks to validate the effectiveness and safety of DTx in improving muscle strength and physical function through a randomized controlled trial (RCT). Research Hypothesis In patients with sarcopenia, the group using digital therapeutics (DTx) will demonstrate superior outcomes in muscle strength improvement and safety compared to the self-exercise group.
Eligibility
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