[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527683":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":25,"locations":36,"responsibleParty":70,"collaborators":73,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":25,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":25,"enrollmentInfo":91,"targetDuration":25,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cardiac rehabilitation","EXPERIMENTAL","For patient randomized to cardiac rehabilitation, the ACHD clinician will place the referral after they and the patient have seen the group assignment. All participants will be referred to Heart Fit for Life community-based cardiac rehabilitation program in Palo Alto, CA. Cardiac rehabilitation will be offered as an in-person, hybrid, or completely virtual program for Stanford participants and will be entirely virtual for Vanderbilt participants. Participants will attend 3 sessions per week for 12 weeks. Participants will receive weekly email reminders via the electronic medical record to encourage participation. The study protocol pertains only to referral to cardiac rehabilitation. All other aspects of the cardiac care will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking.",[13],"Behavioral: Cardiac rehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","ACTIVE_COMPARATOR","For patients randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking.",[19],"Other: Usual care",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Cardiac rehabilitation is a multifaceted, comprehensive therapeutic intervention of personalized, supervised exercise training that is beneficial and well-studied among patients with non-ACHD heart failure and has consistently been shown to improve QOL. Unfortunately, cardiac rehabilitation has been underutilized with an overall participation \\\u003C50% of eligible patients despite international guidelines advocating for more consistent deployment of cardiac rehabilitation. A major a barrier to cardiac rehabilitation is access, as CMS-mandates a physician be within 3 minutes of the rehabilitation facility to assure insurance reimbursement. This mandate limits isolated, outpatient cardiac rehabilitation programs, especially in rural communities.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"For participants randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians.",[15],[30,33],{"name":31,"affiliation":5,"role":32},"Daniel E Clark, MD, MPH","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Jonathan N Menachem, MD","Vanderbilt University Medical Center",[37,56],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Stanford","California","94305","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-122.16608,37.42411,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":54,"phoneExt":25,"email":55},"DANIEL CLARK, MD, MPH","CONTACT","650-724-9220","danclark@stanford.edu",{"facility":35,"status":38,"city":57,"state":58,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Nashville","Tennessee","37240",{"type":45,"coordinates":61},[62,63],-86.78444,36.16589,{"lat":63,"lon":62},[66],{"name":67,"role":53,"phone":68,"phoneExt":25,"email":69},"Jonathan Menachem, MD","615-322-2318","\"Jonathan Menachem\" \u003Cjonathan.n.menachem@vumc.org>",{"type":32,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Daniel Clark","Assistant Professor of Adult and Pediatric Cardiology",[74,75,78,80],{"name":35,"class":6},{"name":76,"class":77},"Adult Congenital Heart Association","UNKNOWN",{"name":79,"class":77},"Julie Fletcher Memorial Fund",{"name":81,"class":77},"Pete Huttlinger Memorial Fund","100527683","rehab-fontan-failure-a-trial-of-cardiac-rehabilitation-100527683",false,"NCT06150950","REHAB Fontan Failure: A Trial of Cardiac Rehabilitation","RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure","Inclusion Criteria:\n\n* Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF \\\u003C50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and\u002For peak VO2 \\\u003C 50% predicted (by FRIEND equation)\n* Age \\>= 18 years old\n\nExclusion Criteria:\n\n* Inotrope-dependence\n* Symptomatic, uncontrolled arrhythmias\n* Pregnancy\n* Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation\n* Inability to comply with the protocol\n* Recent (\\\u003C3 months) planned Fontan pathway percutaneous or surgical intervention\n* Resting hypoxemia with baseline oxygen saturation \\\u003C80%","ALL","18 Years",{"count":92,"type":93},50,"ESTIMATED","INTERVENTIONAL",[96],"NA","The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life.\n\n1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care?\n2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?",[99,100],"Heart Failure Congenital","Single-ventricle",[102,103,9],"Fontan","Single ventricle","2025-12-31",{"date":106,"type":107},"2026-01-05","ACTUAL",{"date":109,"type":107},"2024-05-05",{"date":111,"type":93},"2026-12-31",{"name":5,"class":6},2]