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

NCT07319377 | Recruiting DMC

• 1 other identifier: HC25DDDS0072
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Change in peak knee extension strength (Nm) from baseline to 12 weeks

  Between-group comparison of mean change in knee extensor strength measured by lower extremity dynamometer.

  12 weeks after Visit 1 (treatment initiation)

Secondary Outcomes (12)

• Change in peak isometric knee extension strength (Nm) from baseline to 4, 8, and 24 weeks

  Baseline, 4 weeks, 8 weeks, and 24 weeks after Visit 1 (treatment initiation)

• Change in body composition (skeletal muscle mass index, fat mass)

  12 weeks after Visit 1 (treatment initiation)

• Change in Manual Muscle Test (MMT) scores of major limb muscles

  12 weeks after Visit 1 (treatment initiation)

• Change in Fugl-Meyer Assessment (upper/lower extremities; CNS-related sarcopenia subgroup)

  12 weeks after Visit 1 (treatment initiation)

• Change in Functional Ambulation Category (FAC) score

  12 weeks after Visit 1 (treatment initiation)

Study Arms (2)

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

EXPERIMENTAL

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

Device: exoDTx

Control Group (Self-exercise)

ACTIVE COMPARATOR

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.

Behavioral: Self-exercise (Educational Material)

Interventions

exoDTx 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).

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

Self-exercise (Educational Material) 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).

Control Group (Self-exercise)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Exosystems: lead
• The Catholic University of Korea: collaborator

Study Sites (3)

Bucheon St. Mary's Hospital

Bucheon-si, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, South Korea

NOT YET RECRUITING

St.Vincent's hospital

Suwon, South Korea

NOT YET RECRUITING

Related Publications (1)

• Song K, Eun Shin H, Park W, Lee D, Jang J, Yang Shim G, Choi S, Kim M, Lee H, Won Won C. Digital Biomarker for Muscle Function Assessment Using Surface Electromyography With Electrical Stimulation and a Non-Invasive Wearable Device. IEEE Trans Neural Syst Rehabil Eng. 2024;32:3048-3058. doi: 10.1109/TNSRE.2024.3444890. Epub 2024 Aug 26.

  PMID: 39150814 RESULT

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Sangui Choi, CPO

  Exosystems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangui Choi, CPO

CONTACT

+82-10-3028-7759; tkddml30@exosystems.io

Eun Ji Lee, AP

CONTACT

+82-10-5205-8976; eunjilv7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: January 6, 2026
• Study Start: November 28, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)