[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473267":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":44,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":28,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Home exercise intervention","* Personalized 16 week home exercise program - aerobic exercise for 20 minutes per day\u002F4 days per week and light resistance exercise using resistance bands 3 days per week.\n* Aerobic sessions will include walking, biking, or light jogging, depending on access to facilities\u002Fequipment and weather.\n* Smartwatch for the length of the intervention and a heart rate monitor during exercise sessions.\n* Max heart rate prescribed will be 80% of that on recent cardiopulmonary exercise test (at most 150 beats\u002Fmin).\n* Heart rate monitor will sync with the smartwatch.\n* Activity and heart rate data will be transmitted to the study team via a data hub connected to the participant's home internet modem several times per week.\n* Periodic text messaging to remind participants to wear the watch, sync the data, or adhere to heart rate goals, to ask about symptoms, or to support activity progress.\n* Multiple ways to contact the study team with questions or concerns.",[12],"Behavioral: Exercise intervention",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","Exercise intervention","16-week home exercise intervention, enriched by mobile health technology",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Catherine Avitabile, MD","CONTACT","215-590-4040","avitabilec@chop.edu",[27],{"facility":5,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-75.16362,39.95238,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":19,"phoneExt":19,"email":25},{"type":43,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[45],{"name":46,"class":47},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100473267","itone-trial-exercise-training-in-pulmonary-hypertension-exercise-program-for-pediatric-ph-100473267",false,"NCT05442671","iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH","Home Exercise Training in Pediatric Pulmonary Hypertension","iTONE","Inclusion Criteria:\n\n* Age 8-18 years\n* PH World Health Organization (WHO) diagnostic groups 1, 2, 3, or 4 (pulmonary arterial hypertension, PH due to left heart disease, PH due to lung disease, chronic thromboembolic PH)\n* WHO functional class I or II\n* Ambulatory status\n* Mean pulmonary to systemic arterial pressure ratio \\\u003C0.75 if the patient has not undergone a pulmonary to systemic artery shunt (\"Potts\" shunt) OR the placement of a Potts shunt ≥ 6 months prior to study enrollment\n* Stable PH medication regimen for 3 months prior to the intervention\n* Home Wifi connection\n* Mobile device in family capable of receiving text messages\n\nExclusion Criteria:\n\n* WHO functional class III or IV\n* Single ventricle physiology\n* Moderate to severe renal disease (\\>stage 3)\n* Severe hepatic impairment \\[aspartate aminotransferase (AST)\u002Falanine transaminase (ALT) \\> 2x upper limit of normal\\]\n* Current pregnancy\n* Significant developmental delay\u002Finability to comply with verbal instructions to complete the study procedures","ALL","8 Years","18 Years",{"count":60,"type":61},25,"ESTIMATED","INTERVENTIONAL",[64],"NA","Children with pulmonary hypertension (PH) engage in less physical activity than their peers. This is a concern since adult data support exercise as a non-pharmacologic treatment for PH. Despite adult data, therapeutic exercise has not been widely adopted in pediatric PH. Investigators have previously demonstrated that children with PH have less skeletal muscle mass in association with worse exercise performance. Interventions to increase physical activity and skeletal muscle mass may improve exercise performance and quality of life in children with PH. This study will use wearable activity monitoring devices to promote physical activity in a 16-week pilot intervention in children and teenager with PH.",[67],"Pulmonary Hypertension",[69],"Actigraphy","2026-04-17",{"date":72,"type":73},"2026-04-22","ACTUAL",{"date":75,"type":73},"2024-04-03",{"date":77,"type":61},"2026-12-31",{"name":5,"class":6},1]