[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636957":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Remote Cardiac Rehabilitation Group","EXPERIMENTAL","Participants randomly assigned to this group will receive a 12-week remote cardiac rehabilitation program followed by a 12-week follow-up period (total 24 weeks).",[13,14],"Behavioral: Community-Based Remote Cardiac Rehabilitation Program","Behavioral: standard of care",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","Participants randomly assigned to this group will receive the standard of care for 24 weeks. After the 24-week evaluation, they will be offered a 1-month exercise education program opportunity.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Community-Based Remote Cardiac Rehabilitation Program","The program consists of supervised remote exercise via ZOOM once a week (approx. 60 minutes, including warm-up, aerobic, resistance, respiratory, and cool-down exercises) and self-directed exercise 3 to 7 times a week. Biological signals (ECG, heart rate, SpO2) are monitored using wearable devices (mobiCARE, pulse oximeter, and smartwatch). A respiratory muscle training device (POWERbreathe) is also utilized.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"standard of care","Participants will maintain their usual outpatient care, medications, and standard physical activity guidelines for without the remote structured intervention.",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Sungbae Jo Research Professor, Ph.D","CONTACT","82-2-2072-4178","sungbaejo@snuh.org",[38],{"facility":5,"status":39,"city":40,"state":26,"zip":41,"country":42,"countryCode":26,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Seoul","03080","South Korea",{"type":44,"coordinates":45},"Point",[46,47],126.9784,37.566,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Sung Eun Hyun","Associate Professor",[56],{"name":57,"class":6},"University of Seoul","100636957","preliminary-efficacy-of-a-remote-cardiac-rehabilitation-program-in-pediatric-patients-with-complex-congenital-heart-disease-100636957",false,"NCT07572435","Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease","Preliminary Efficacy of a Community-Based Remote Cardiac Rehabilitation Program on Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease: A Single Blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 8 to 18 years.\n* Diagnosed with complex congenital heart disease (e.g., single ventricle, transposition of the great arteries) and have a history of cardiac surgery.\n* At least 3 months post-cardiac surgery and maintaining a stable hemodynamic status.\n* Capable of utilizing remote programs (mobile apps, video platforms, etc.) in the home environment with technical support from guardians.\n* Participant or guardian has agreed to participate and signed the written informed consent form.\n* Confirmed to have decreased physical activity level and physical well-being through assessments (Must meet both):\n* KIDSCREEN-27 Parent Proxy-report 'Physical well-being' domain T-score of 40 or below.\n* Exercise Vital Sign (EVS) survey indicating moderate-to-vigorous physical activity (MVPA) time of less than 420 minutes per week.\n\nExclusion Criteria:\n\n* Ongoing cardiovascular diseases such as uncontrolled arrhythmia, acute heart failure, myocarditis, or pericarditis.\n* Neurological or musculoskeletal disorders that make independent exercise impossible.\n* Cognitive impairment that prevents understanding or following the instructions of the remote rehabilitation program.\n* Clinical levels of depression or anxiety restricting exercise participation, as determined by the attending physician (assessed via Korean Children's Depression Inventory 2: Self-Report \\[K-CDI-2:SR\\] and Revised Children's Manifest Anxiety Scale, Second Edition \\[RCMAS-2\\]).\n* Inability to cooperate with study tests, such as the Cardiopulmonary Exercise Test (CPET), Electrocardiogram (ECG), and 6-Minute Walk Test (6MWT).\n* Currently wearing an artificial pacemaker.","ALL","8 Years","18 Years",{"count":69,"type":70},45,"ESTIMATED","INTERVENTIONAL",[73],"NA","This study aims to evaluate the preliminary efficacy of a 12-week community-based remote cardiac rehabilitation program on cardiopulmonary function and quality of life in pediatric patients (aged 8 to 18 years) with complex congenital heart disease. Participants will be randomly assigned to either an experimental group receiving the remote cardiac rehabilitation program or a control group receiving the standard of care.",[76],"Complex Congenital Heart Disease","2026-05-06",{"date":79,"type":80},"2026-05-07","ACTUAL",{"date":82,"type":70},"2026-05-01",{"date":84,"type":70},"2029-12-31",{"name":5,"class":6},1]