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

Official title

A Multicenter, Prospective, Randomized, Parallel-Group, Double-blinded, Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of a Digital Therapeutic Device for Improving Muscle Strength in Patients With Sarcopenia

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.

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.

Interventions

• 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. Ini
• 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

Primary outcome measures

• Change in peak knee extension strength (Nm) from baseline to 12 weeks [Time frame: 12 weeks after Visit 1 (treatment initiation)]

Secondary outcome measures (12)

• Change in peak isometric knee extension strength (Nm) from baseline to 4, 8, and 24 weeks [Time frame: Baseline, 4 weeks, 8 weeks, and 24 weeks after Visit 1 (treatment initiation)]
• Change in body composition (skeletal muscle mass index, fat mass) [Time frame: 12 weeks after Visit 1 (treatment initiation)]
• Change in Manual Muscle Test (MMT) scores of major limb muscles [Time frame: 12 weeks after Visit 1 (treatment initiation)]
• Change in handgrip strength (kg) from baseline [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks]
• Change in calf circumference (cm) from baseline [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks]
• Change in Muscle Function Index (MFI) from surface EMG analysis [Time frame: 12 weeks after Visit 1 (treatment initiation)]
• Change in Fugl-Meyer Assessment (upper/lower extremities; CNS-related sarcopenia subgroup) [Time frame: 12 weeks after Visit 1 (treatment initiation)]
• Change in 30-second chair stand test (repetitions) from baseline [Time frame: 12 weeks after Visit 1 (treatment initiation)]
• Change in Functional Ambulation Category (FAC) score [Time frame: 12 weeks after Visit 1 (treatment initiation)]
• Change in Berg Balance Scale (BBS) and Timed Up and Go (TUG) performance [Time frame: 12 weeks after Visit 1 (treatment initiation)]
• Change in Short Physical Performance Battery (SPPB) total score and subscores (chair stand, gait speed, balance) [Time frame: 12 weeks after Visit 1 (treatment initiation)]
• Change in Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls Questionnaire Score [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks]

Eligibility criteria

Inclusion criteria

• Individuals diagnosed with sarcopenia according to both the European Working Group on Sarcopenia in Older People (EWGSOP) criteria and the Asian Working Group for Sarcopenia 2019 (AWGS 2019) criteria
• Individuals with reduced muscle strength, defined as at least one of the following:
• Handgrip strength < 28 kg for men or < 18 kg for women
• Five-times Sit-to-Stand Test time > 12 seconds without arm support
• Individuals with reduced muscle mass, defined as at least one of the following:
• Skeletal Muscle Mass Index (SMI) < 7.0 kg/m² for men or < 5.4 kg/m² for women measured by DXA
• Skeletal Muscle Mass Index (SMI) < 7.0 kg/m² for men or < 5.7 kg/m² for women measured by BIA
• Individuals able to independently perform sit-to-stand movements
• Individuals with sufficient physical and cognitive capacity to participate in the exercise program
• Individuals able and willing to provide written informed consent
• Individuals able to operate a mobile phone independently or with assistance from a caregiver

Exclusion criteria

• Individuals with cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score < 20, or those unable to participate due to cognitive decline
• Individuals with an implanted cardiac pacemaker or other implanted electronic medical device
• Individuals with uncontrolled cardiovascular disease despite appropriate medical management
• Individuals who have undergone lower-limb surgery within the past 6 months and are unable to ambulate independently
• Individuals with moderate-to-severe musculoskeletal pain or functional limitations that interfere with objective functional assessments
• Individuals with severe obesity, defined as a body mass index (BMI) > 50 kg/m²
• Individuals currently receiving active cancer treatment or experiencing severe systemic frailty
• Individuals with hemiplegia that prevents participation in the prescribed exercise program
• Individuals who are anticipated by the investigator to be unable to complete the study procedures or follow-up assessments
• Individuals unable to understand or comply with study instructions provided in Korean
• Individuals considered unsuitable for study participation at the discretion of the investigator for any other reason

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

South Korea · 2 centers

• Bucheon St. Mary's Hospital — Bucheon-si
• St.Vincent's hospital — Suwon

Publications

• 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

Identifiers

NCT: NCT07319377 · HC25DDDS0072

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗