SarcopeniaNCT07319377
Evaluation of Safety and Efficacy of a Digital Therapeutic Device to Improve Strength in Sarcopenia (Sarc-DTx)
A study testing exoDTx and Self-exercise (Educational Material) in people with Sarcopenia, run by Exosystems at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- exoDTx and Self-exercise (Educational Material)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 28 Nov 2025to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Bucheon St. Mary's Hospital
Bucheon-si
St.Vincent's hospital
Suwon
About this study
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
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.
Read the 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
- Being tested
- exoDTx, Self-exercise (Educational Material)
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exoDTxDevice
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Self-exercise (Educational Material) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after Visit 1 (treatment initiation)
Secondary outcomes (16)
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.
Measured: Baseline, 4 weeks, 8 weeks, and 24 weeks after Visit 1 (treatment initiation)
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.
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks after Visit 1 (treatment initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start28 Nov 2025
- Primary completion23 Sep 2026
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exosystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea
- Responsible party
- Sponsor
- Investigators
- Sangui Choi, CPO, Principal investigator, Exosystems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319377
- Sponsor's protocol ID
- HC25DDDS0072
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39150814
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07319377
- Acronym / sponsor ID
- HC25DDDS0072
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- ExosystemsIndustry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Device Group (Home-based DTx exercise group after training) | Experimental | Device: exoDTxParticipants 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 |
| Control Group (Self-exercise) | Active comparator | Behavioral: Self-exercise (Educational Material)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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exoDTxExperimental 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). | Device | Experimental Device Group (Home-based DTx exercise group after training) |
| 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). | Behavioural | Control Group (Self-exercise) |
Primary outcome
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.
16 secondary outcomes
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
Change in Sarcopenia Quality of Life score
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Change in EuroQol Five-Dimension Five-Level (EQ-5D-5L) Questionnaire Score
Time frame: 12 weeks after Visit 1 (treatment initiation)
Change in Self-Efficacy for Home Exercise Programs Scale score
Time frame: 12 weeks after Visit 1 (treatment initiation)
System Usability Scale (SUS) total score of the exoDTx mobile application
Time frame: 12 weeks after Visit 1 (treatment initiation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Results publication: PubMed 39150814Song 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangui Choi, CPO principal investigator
Exosystems
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exoDTx and Self-exercise (Educational Material) in people with Sarcopenia, run by Exosystems at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak knee extension strength (Nm) from baseline to 12 weeks (time frame: 12 weeks after Visit 1 (treatment initiation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07319377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.