[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100406704":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":52,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":19,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":19,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Alberta","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MedBIKE HIIT","EXPERIMENTAL","MedBIKE HIIT Exercise Program",[13],"Device: MedBIKE HIIT",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Participants will complete a high intensity interval training exercise program 3 times a week for 12 weeks (36 sessions total)",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Michael Khoury, MD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Rae Foshaug","CONTACT","7804077499","rae.foshaug@albertahealthservices.ca",{"name":22,"role":27,"phone":31,"phoneExt":19,"email":32},"7804920103","khoury1@ualberta.ca",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Edmonton","Alberta","T6G 2B7","Canada","CA",{"type":42,"coordinates":43},"Point",[44,45],-113.46871,53.55014,{"lat":45,"lon":44},[48,50,51],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":49},"raef@ualberta.ca",{"name":22,"role":27,"phone":31,"phoneExt":19,"email":32},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":53,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[55],{"name":56,"class":6},"Heart and Stroke Foundation of Canada","100406704","hiit-in-youth-with-congenital-heart-disease-medbike-100406704",false,"NCT04575883","HIIT in Youth With Congenital Heart Disease (MedBIKE)","High Intensity Interval Training in Youth With Congenital Heart Disease: A Prospective Clinical Trial of a Novel Telemedicine Video Game-Linked Exercise Platform","Inclusion Criteria:\n\n* Children and adolescents aged 10-18 years\n* Repaired moderate-complex congenital heart disease\n\nExclusion Criteria:\n\n* Non-English speaking (thus limiting communication during the MedBIKE™ sessions)\n* Home environment cannot accommodate the MedBIKE™ system (space limitations)\n* Previous involvement in a cardiac rehab or exercise intervention program\n* Primary cardiologist has exercise restricted the participant or counsels against participation\n* Previous exercise stress test demonstrating sustained arrhythmias, ST segment elevation or depression greater than 3mm, an inappropriate rise in blood pressure (BP) (\\\u003C20 mmHg) or a systolic BP \\>200 mmHg, or symptoms of chest pain or syncope\n* Resting arterial saturation \\\u003C85% or oxygen requirements\n* Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram\n* History of chest pain on exertion\n* Unrepaired\u002Funpalliated CHD\n* Arrhythmias in the last year (including supraventricular tachycardia, ventricular tachycardia, atrioventricular block (Mobitz II or worse))\n* New York Heart Association class II or worse symptoms\n* Active medical inter-current illness limiting ability to participate\n* Cognitive impairment limiting the communication needed for the HIIT program\n* Extracardiac or congenital abnormality limiting the participant's functional ability to exercise","ALL","10 Years","18 Years",{"count":68,"type":69},44,"ESTIMATED","INTERVENTIONAL",[72],"NA","Congenital heart disease (CHD), the most common birth defect, is present in nearly 1% of the population. CHD patients are associated with intense resource utilization and premature death in adulthood. The risk of premature death is linked with reduced exercise capacity, a finding consistently noted in youth with CHD. Reduced exercise capacity in this population has also been associated with reduce physical activity and health-related quality of life.\n\nCardiac rehabilitation (CR) in adults with acquired heart disease is an established secondary prevention strategy that improves exercise capacity. The investigators propose a prospective clinical trial of a home-based high intensity interval training (HIIT) program using a novel telemedicine-equipped video game-linked cycle ergometer (MedBIKE™) for 10 to 18 year olds with repaired moderate-complex CHD. The pilot study with the MedBIKE has shown promising results. The investigators now seek to study the efficacy of this program in a broader CHD population.",[75,76],"Congenital Heart Disease","Pediatric ALL",[78,79,80],"Cardiac rehabilitation","High Intensity Interval Training","Telemedicine","2026-02-04",{"date":83,"type":84},"2026-02-05","ACTUAL",{"date":86,"type":84},"2022-11-22",{"date":88,"type":69},"2026-12-31",{"name":5,"class":6},1]