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| Name | Class |
|---|---|
| The Catholic University of Korea | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak isometric knee extension strength (Nm) from baseline to 4, 8, and 24 weeks | To evaluate longitudinal changes in knee extensor muscle strength at weeks 4, 8, and 24 compared with baseline using an lower extremity dynamometer. | Baseline, 4 weeks, 8 weeks, and 24 weeks after Visit 1 (treatment initiation) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sangui Choi, CPO | Contact | +82-10-3028-7759 | tkddml30@exosystems.io | |
| Eun Ji Lee, AP | Contact | +82-10-5205-8976 | eunjilv7@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sangui Choi, CPO | Exosystems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon St. Mary's Hospital | Recruiting | Bucheon-si | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39150814 | Result | 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. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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). |
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| Change in body composition (skeletal muscle mass index, fat mass) |
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. |
| 12 weeks after Visit 1 (treatment initiation) |
| Change in Manual Muscle Test (MMT) scores of major limb muscles | To assess changes in muscle strength based on standardized MMT grading (0-5 scale) after 12 weeks of intervention.. | 12 weeks after Visit 1 (treatment initiation) |
| Change in handgrip strength (kg) from baseline | To assess longitudinal changes in handgrip strength measured by hand dynamometer at weeks 4, 8, 12, and 24. | Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks |
| Change in calf circumference (cm) from baseline | 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. | Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks |
| Change in Muscle Function Index (MFI) from surface EMG analysis | To quantify changes in muscle fatigue characteristics derived from surface electromyography (EMG) during resistance exercises. | 12 weeks after Visit 1 (treatment initiation) |
| Change in Fugl-Meyer Assessment (upper/lower extremities; CNS-related sarcopenia subgroup) | To examine motor recovery and coordination improvements using the Fugl-Meyer Assessment in participants with CNS-related sarcopenia. | 12 weeks after Visit 1 (treatment initiation) |
| Change in 30-second chair stand test (repetitions) from baseline | 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. | 12 weeks after Visit 1 (treatment initiation) |
| Change in Functional Ambulation Category (FAC) score | To assess improvement in walking independence level using the Functional Ambulation Category (0-5 scale). | 12 weeks after Visit 1 (treatment initiation) |
| Change in Berg Balance Scale (BBS) and Timed Up and Go (TUG) performance | To evaluate dynamic and static balance performance using BBS score and TUG test time. | 12 weeks after Visit 1 (treatment initiation) |
| Change in Short Physical Performance Battery (SPPB) total score and subscores (chair stand, gait speed, balance) | 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 weeks after Visit 1 (treatment initiation) |
| Change in Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls Questionnaire Score | 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. | Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks |
| Change in Sarcopenia Quality of Life score | 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. | Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks |
| Change in EuroQol Five-Dimension Five-Level (EQ-5D-5L) Questionnaire Score | 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. | 12 weeks after Visit 1 (treatment initiation) |
| Change in Self-Efficacy for Home Exercise Programs Scale score | To evaluate participants' confidence in independently performing prescribed home-based exercises. | 12 weeks after Visit 1 (treatment initiation) |
| System Usability Scale (SUS) total score of the exoDTx mobile application | To assess user satisfaction and perceived usability of the exoDTx digital therapeutic application using SUS. | 12 weeks after Visit 1 (treatment initiation) |
| St.Vincent's hospital | Recruiting | Suwon | South Korea |
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |