Evaluation of Safety and Efficacy of a Digital Therapeutic Device to Improve Strength in Sarcopenia (Sarc-DTx)

Exosystems

Status: Enrolling

Conditions: Sarcopenia

Treatments: Device: exoDTx; Behavioral: Self-exercise (Educational Material)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07319377

HC25DDDS0072

Details and patient eligibility

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Experimental Device Group (Home-based DTx exercise group after training)

Experimental group

Description:

Participants perform personalized resistance exercises using a digital therapeutic device (mobile application) at home for 12 weeks, with sessions conducted at least 3 times per week, 50 minutes per session (≥150 minutes/week). The program includes exercise automatic intensity adjustment, exercise recording/analysis, and physician monitoring

Treatment:

Device: exoDTx

Control Group (Self-exercise)

Active Comparator group

Description:

No mobile application is used. Participants perform the same type of exercise using QR code-based educational materials, self-regulating their exercise time, at least 3 times per week, 50 minutes per session, for a total of 12 weeks, with frequency and duration identical to the experimental group.

Treatment:

Behavioral: Self-exercise (Educational Material)