NCT07319377

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Exosystems · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sarcopenia

Interventions

Type	Name	Description
DEVICE	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).
BEHAVIORAL	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).

Timeline

• Start date: 2025-11-28
• Primary completion: 2026-06-20
• Completion: 2026-09-25
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

3 sites across 1 country: South Korea