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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-28

Study Completion Date

2026-09-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

exoDTx

Intervention Type DEVICE

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 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.

Group Type ACTIVE_COMPARATOR

Self-exercise (Educational Material)

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type DEVICE

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No