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NCT Number: NCT07319377

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

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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Key information

Conditions

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

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bucheon St. Mary's Hospital, Bucheon-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

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

    Time frame: 12 weeks after Visit 1 (treatment initiation)

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

Secondary outcomes

  1. 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)

    To evaluate longitudinal changes in knee extensor muscle strength at weeks 4, 8, and 24 compared with baseline using an lower extremity dynamometer.

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

    Time frame: 12 weeks after Visit 1 (treatment initiation)

    To evaluate changes in muscle and fat mass measured by dual-energy x-ray absorptiometry(DXA) or bioelectrical impedance analysis (BIA) after 12 weeks of intervention.

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

    Time frame: 12 weeks after Visit 1 (treatment initiation)

    To assess changes in muscle strength based on standardized MMT grading (0-5 scale) after 12 weeks of intervention..

  4. Change in handgrip strength (kg) from baseline

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

    To assess longitudinal changes in handgrip strength measured by hand dynamometer at weeks 4, 8, 12, and 24.

  5. Change in calf circumference (cm) from baseline

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

    To assess longitudinal changes in calf circumference measured at the maximum girth of the dominant or less-affected lower leg at weeks 4, 8, 12, and 24.

  6. Change in Muscle Function Index (MFI) from surface EMG analysis

    Time frame: 12 weeks after Visit 1 (treatment initiation)

    To quantify changes in muscle fatigue characteristics derived from surface electromyography (EMG) during resistance exercises.

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

    Time frame: 12 weeks after Visit 1 (treatment initiation)

    To examine motor recovery and coordination improvements using the Fugl-Meyer Assessment in participants with CNS-related sarcopenia.

  8. Change in 30-second chair stand test (repetitions) from baseline

    Time frame: 12 weeks after Visit 1 (treatment initiation)

    To assess changes in lower limb functional strength and endurance measured by the number of sit-to-stand repetitions completed in 30 seconds after 12 weeks of intervention.

  9. Change in Functional Ambulation Category (FAC) score

    Time frame: 12 weeks after Visit 1 (treatment initiation)

    To assess improvement in walking independence level using the Functional Ambulation Category (0-5 scale).

  10. Change in Berg Balance Scale (BBS) and Timed Up and Go (TUG) performance

    Time frame: 12 weeks after Visit 1 (treatment initiation)

    To evaluate dynamic and static balance performance using BBS score and TUG test time.

  11. 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)

    To assess lower extremity function using SPPB, including 5-time chair stand, 6-meter gait speed, and balance tests.

    SPPB - 5-time chair stand (time) 6-meter gait speed (SPPB gait speed) SPPB balance - score SPPB balance - time in seconds

  12. 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

    To assess changes in self-reported sarcopenia risk using the full Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls questionnaire. The SARC-F consists of 5 items, each scored from 0 to 2, resulting in a total score ranging from 0 to 10, with higher scores indicating worse sarcopenia severity and greater functional limitation.

  13. Change in Sarcopenia Quality of Life score

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

    To measure sarcopenia-specific quality of life changes using Sarcopenia Quality of Life total score and domain subscores.

    Sarcopenia Quality of Life contains 55 items generating a total score from 0 to 100, with higher scores indicating better quality of life.

  14. Change in EuroQol Five-Dimension Five-Level (EQ-5D-5L) Questionnaire Score

    Time frame: 12 weeks after Visit 1 (treatment initiation)

    To assess changes in self-reported health-related quality of life using the full EuroQol Five-Dimension Five-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L consists of 5 items, each scored from 1 to 5, resulting in a total score ranging from 5 to 25, with lower scores indicating better health-related quality of life and higher scores indicating greater health impairment.

  15. Change in Self-Efficacy for Home Exercise Programs Scale score

    Time frame: 12 weeks after Visit 1 (treatment initiation)

    To evaluate participants' confidence in independently performing prescribed home-based exercises.

  16. System Usability Scale (SUS) total score of the exoDTx mobile application

    Time frame: 12 weeks after Visit 1 (treatment initiation)

    To assess user satisfaction and perceived usability of the exoDTx digital therapeutic application using SUS.

Study contacts

Contact information is provided by the study sponsor or research team.

Eun Ji Lee, AP

CONTACT

[email protected]

+82-10-5205-8976

Sangui Choi, CPO

CONTACT

[email protected]

+82-10-3028-7759

Sponsors and collaborators

Lead sponsor

Exosystems

Industry

Collaborators

  • The Catholic University of Korea

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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