[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617496":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":80,"collaborators":82,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":26,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Exosystems","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002Fweek). The program includes exercise automatic intensity adjustment, exercise recording\u002Fanalysis, and physician monitoring",[13],"Device: exoDTx",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: Self-exercise (Educational Material)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","exoDTx","Experimental group (exoDTx): After baseline on-site training, participants perform personalized resistance exercises at home using a mobile app ≥3 times\u002Fweek, 50 min\u002Fsession, for 12 weeks (≥150 min\u002Fweek). The program provides grip strength-based automatic intensity adjustment, exercise recording, feedback, and physician monitoring.\n\nDelivery: Nonpharmacological, non-invasive, home-based exercise program. The experimental group uses a mobile app; the control group uses educational materials.\n\nInitial instruction occurs on-site. Visits \\& Monitoring: Screening\u002FBaseline (week 0), In-treatment (weeks 4, 8), Post-treatment (week 12), and Follow-up (week 24).",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"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\u002Fweek, 50min\u002Fsession, for 12 weeks, maintaining exercise logs without automatic adjustment or remote monitoring.\n\nDelivery: 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\u002FBaseline (week 0), In-treatment (weeks 4, 8), Post-treatment (week 12), and Follow-up (week 24).",[15],[33],{"name":34,"affiliation":5,"role":35},"Sangui Choi, CPO","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+82-10-3028-7759","tkddml30@exosystems.io",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Eun Ji Lee, AP","+82-10-5205-8976","eunjilv7@gmail.com",[46,67],{"facility":47,"status":48,"city":49,"state":26,"zip":26,"country":50,"countryCode":26,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Bucheon St. Mary's Hospital","RECRUITING","Bucheon-si","South Korea",{"type":52,"coordinates":53},"Point",[54,55],126.78306,37.49889,{"lat":55,"lon":54},[58,62,65],{"name":59,"role":38,"phone":60,"phoneExt":26,"email":61},"Ji-Su Hong, Clinical Research Coordinator","8210-3279-3106","tlaak23@hanmail.net",{"name":63,"role":38,"phone":64,"phoneExt":26,"email":44},"Eun Ji Lee, Clinical Assistant Professor","8210-5205-8976",{"name":66,"role":35,"phone":26,"phoneExt":26,"email":26},"Sun Im, Professor",{"facility":68,"status":48,"city":69,"state":26,"zip":26,"country":50,"countryCode":26,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"St.Vincent's hospital","Suwon",{"type":52,"coordinates":71},[72,73],127.00889,37.29111,{"lat":73,"lon":72},[76],{"name":77,"role":38,"phone":78,"phoneExt":26,"email":79},"Mi-Jeong Yoon, Assistant Professor","+8210-9507-2638","allogen@naver.com",{"type":81,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[83],{"name":84,"class":85},"The Catholic University of Korea","OTHER","100617496","evaluation-of-safety-and-efficacy-of-a-digital-therapeutic-device-to-improve-strength-in-sarcopenia-sarc-dtx-100617496",false,"NCT07319377","Evaluation of Safety and Efficacy of a Digital Therapeutic Device to Improve Strength in Sarcopenia (Sarc-DTx)","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","Inclusion Criteria\n\n* 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\n* Individuals with reduced muscle strength, defined as at least one of the following:\n* Handgrip strength \\\u003C 28 kg for men or \\\u003C 18 kg for women\n* Five-times Sit-to-Stand Test time \\> 12 seconds without arm support\n* Individuals with reduced muscle mass, defined as at least one of the following:\n* Skeletal Muscle Mass Index (SMI) \\\u003C 7.0 kg\u002Fm² for men or \\\u003C 5.4 kg\u002Fm² for women measured by DXA\n* Skeletal Muscle Mass Index (SMI) \\\u003C 7.0 kg\u002Fm² for men or \\\u003C 5.7 kg\u002Fm² for women measured by BIA\n* Individuals able to independently perform sit-to-stand movements\n* Individuals with sufficient physical and cognitive capacity to participate in the exercise program\n* Individuals able and willing to provide written informed consent\n* Individuals able to operate a mobile phone independently or with assistance from a caregiver\n\nExclusion Criteria\n\n* Individuals with cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \\\u003C 20, or those unable to participate due to cognitive decline\n* Individuals with an implanted cardiac pacemaker or other implanted electronic medical device\n* Individuals with uncontrolled cardiovascular disease despite appropriate medical management\n* Individuals who have undergone lower-limb surgery within the past 6 months and are unable to ambulate independently\n* Individuals with moderate-to-severe musculoskeletal pain or functional limitations that interfere with objective functional assessments\n* Individuals with severe obesity, defined as a body mass index (BMI) \\> 50 kg\u002Fm²\n* Individuals currently receiving active cancer treatment or experiencing severe systemic frailty\n* Individuals with hemiplegia that prevents participation in the prescribed exercise program\n* Individuals who are anticipated by the investigator to be unable to complete the study procedures or follow-up assessments\n* Individuals unable to understand or comply with study instructions provided in Korean\n* Individuals considered unsuitable for study participation at the discretion of the investigator for any other reason","ALL","50 Years","85 Years",{"count":97,"type":98},130,"ESTIMATED","INTERVENTIONAL",[101],"NA","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.",[104],"Sarcopenia","2026-06-21",{"date":107,"type":108},"2026-06-25","ACTUAL",{"date":110,"type":108},"2025-11-28",{"date":112,"type":98},"2026-12-30",{"name":5,"class":6},2]