[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490746":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":135,"collaborators":24,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":24,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":24,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Neurocardiac rehabilitation program","EXPERIMENTAL","The home-based neuro-cardiac rehabilitation program will consist of weekly sessions of neuro-cardiac training during 12 weeks at home.\n\n* The physical activity training consists of two 1-hour sessions of adapted physical activities per week supervised by an APA educator or equal. One weekly session is held in person, at home, and the second one in videoconference. All training sessions follow the same scheme with 30 minutes of bicycle training, adapted from high-intensity training (30-33), and 30 minutes of \"free\" adapted physical activities\n* The neuropsychological component will consist of 2 home-based weekly 25-minute sessions of computerized cognitive training via the new platform of CogMed (standard format) for the patient and 1 weekly 30\u002F45-min teleconsultation session of neuropsychological feedback on every-day life emotional regulation and executive functioning applied to school and family life for either the parent (for ages 17 and younger) or young adults with CHD.",[13],"Other: Neurocardiac rehabilitation program",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","ACTIVE_COMPARATOR","The control group will follow European recommendations for cardiology care (standard of care) without introducing any additional interventions for research purposes at the exception of primary (HRQoL questionnaires) and secondary outcomes",[19],"Other: Standard of care",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Patients receiving a neurocardiac rehabilitation program for 12 weeks.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"No intervention during the neurocardiac rehabilitation program",[15],[29],{"name":30,"affiliation":5,"role":31},"Pascal AMEDRO, MD,PhD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":30,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","05 57 65 61 09","+33","pascal.amedro@chu-bordeaux.fr",{"name":39,"role":34,"phone":24,"phoneExt":36,"email":40},"Johanna CALDERON, PhD","johanna.calderon@inserm.fr",[42,60,76,90,103,117],{"facility":43,"status":44,"city":45,"state":24,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Saint-Luc University Hospital","RECRUITING","Brussels","Belgium","BE",{"type":49,"coordinates":50},"Point",[51,52],4.34878,50.85045,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":57,"phoneExt":58,"email":59},"Stéphane MONIOTTE, MD,PhD","02 764 19 20","+32","stephane.moniotte@uclouvain.be",{"facility":61,"status":44,"city":62,"state":63,"zip":64,"country":63,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Hôpital Necker-Enfants malades (AP-HP)","Paris","France","75015","FR",{"type":49,"coordinates":67},[68,69],2.3488,48.85341,{"lat":69,"lon":68},[72],{"name":73,"role":34,"phone":74,"phoneExt":36,"email":75},"Damien BONNET, MD,PhD","01 44 49 43 44","damien.bonnet@aphp.fr",{"facility":77,"status":44,"city":78,"state":24,"zip":79,"country":63,"countryCode":65,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"University Hospital of Montpellier - Arnaud de Villeneuve Hospital","Montpellier","34295",{"type":49,"coordinates":81},[82,83],3.87635,43.61093,{"lat":83,"lon":82},[86],{"name":87,"role":34,"phone":88,"phoneExt":36,"email":89},"Sophie GUILLAUMONT, MD","04 67 33 81 12","s-guillaumont@chu-montpellier.fr",{"facility":91,"status":44,"city":92,"state":24,"zip":93,"country":63,"countryCode":65,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Saint-Pierre Institute","Palavas-les-Flots","34250",{"type":49,"coordinates":95},[96,97],3.93043,43.52974,{"lat":97,"lon":96},[100],{"name":87,"role":34,"phone":101,"phoneExt":36,"email":102},"04 67 07 75 51","guillaumont.s@institut-saint-pierre.fr",{"facility":104,"status":44,"city":105,"state":24,"zip":106,"country":63,"countryCode":65,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"University Hospital of Bordeaux - Haut-Levêque Hospital","Pessac","33604",{"type":49,"coordinates":108},[109,110],-0.6324,44.80565,{"lat":110,"lon":109},[113],{"name":114,"role":34,"phone":115,"phoneExt":36,"email":116},"Marion AUDIE, MD","05 57 65 64 65","marion.audie@chu-bordeaux.fr",{"facility":118,"status":119,"city":120,"state":24,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Deutsches Herzzentrum München","NOT_YET_RECRUITING","München","D-80636","Germany","DE",{"type":49,"coordinates":125},[126,127],13.31243,51.60698,{"lat":127,"lon":126},[130],{"name":131,"role":34,"phone":132,"phoneExt":133,"email":134},"alfred HAGER, MD,PhD","089-1218-1650","+49","hager@dhm.mhn.de",{"type":136,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100490746","neuro-cardiac-rehabilitation-in-youth-with-congenital-heart-disease-qualineurorehab-100490746",false,"NCT05670132","Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)","Impact of a Neuro-cardiac Rehabilitation Program on the Quality of Life of Children, Adolescents, and Young Adults With Congenital Heart Disease: the Multicentre Randomized Controlled QUALINEUROREHAB Trial","Inclusion Criteria:\n\n1. Patient with a CHD of moderate to great complexity as defined in the 2019 AHA\u002FACC guidelines (Appendix 2)85.\n2. History of cardiac surgery and\u002For catheter-based cardiac intervention(s) during the first year of life.\n3. Age between 8 and 25 years at the time of enrolment.\n4. Parental or legal guardian's consent for minors (\\\u003C18 years) and personal consent for adults.\n5. Social security affiliation (for France only)\n\nExclusion Criteria:\n\n1. Unstable and\u002For severe heart failure: severe heart failure (class IV NYHA functional class), recent decompensated heart failure requiring hospitalisation and\u002For any significant change in medication (\\\u003C 3 months before enrolment), systolic ventricle dysfunction (left ventricle or systemic ventricle ejection fraction \\\u003C 50%)82.\n2. Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest \\\u003C85%, and\u002For SpO2 at exercise \\\u003C80%, and\u002For patient requiring oxygen therapy.\n3. Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology83.\n4. Significant systolic right ventricle (sRV) hypertension (sRV pressure \\> 50% of systemic systolic pressure).\n5. Uncontrolled arrhythmia: symptomatic treated or untreated arrhythmia at rest and\u002For exercise, treated arrhythmia with sustained supraventricular or ventricular tachycardia on ECG monitoring or during exercise and\u002For CPET, occurrence or aggravation of any supraventricular or ventricular arrhythmia during exercise and\u002For CPET.\n6. Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and\u002For CPET.\n7. Uncontrolled arterial hypertension at rest (e.g. if the blood pressure at rest during the consultation \\>140\u002F90 mmHg in adults, \\>95th percentile in children84).\n8. Acute or recent (\\\u003C 3 months) myocarditis and pericarditis.\n9. Symptomatic aortic or sub-aortic stenosis (mean gradient \\> 50 mmHg).\n10. Non-corrected coarctation of the aorta (surgical or catheter-based repair) with a clinical systolic gradient \\> 20 mmHg.\n11. Dilatation of the aorta (aortic root \\> 40 mm in adults, \\> 2 Z-score in children85 (http:\u002F\u002Fwww.parameterz.com\u002Fsites\u002Faortic-root) except in the case of repaired congenital heart disease with dilatation of the aorta inherent in the malformation and without significant risk of aortic dissection (tetralogy of Fallot, pulmonary atresia with VSD, transposition of the great arteries, truncus arteriosus, double outlet right ventricle, or single ventricle).\n12. Severe hypertrophic obstructive cardiomyopathy.\n13. Acute systemic illness.\n14. Recent (\\\u003C3 months) intracardiac thrombus, embolism, or thrombophlebitis.\n15. Inability to follow instructions and\u002For complete the questionnaires, as determined by the investigator.\n16. Absolute contraindications for CPET: fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or haemodynamic compromise, uncontrolled heart failure, acute pulmonary embolus or pulmonary infarction, and patients with mental impairment leading to inability to cooperate.\n17. Inability to undergo the physical intervention: inability to physically exercise, any invasive medical intervention occurring within 6 months preceding the enrolment or scheduled during the 12-month study period (such as cardiac surgery, catheter-based intervention, orthopaedic surgery, chemotherapy for cancer, or any other significant medical treatment or intervention, as determined by the investigator).\n18. Patient with a previously diagnosed or suspected severe psychiatric disorder (major depression with or without suicidal ideation, psychotic diagnoses, severe anxiety \u002Fpanic disorders) requiring hospitalization and\u002For continuous specialized care by a psychiatrist, as determined by the investigator.\n19. Patients who benefited from a cardiac rehabilitation within the 12 months preceding the enrolment.\n20. Patients who benefited from a computerized executive function or attention training such as Cogmed Working Memory Program within the 12 months preceding the enrolment.\n21. For female patients: pregnancy, pregnancy plan, or breastfeeding woman following questioning of the patient.\n22. Patients deprived of liberty due to an ongoing legal procedure, adult's patient under guardianship or curatorship or unable to personally express their consent.\n23. Any other clinical and\u002For pharmacological treatment that is believed to interfere with the study or the optimal clinical care.\n24. Initiation or total withdrawal of psychotropic medication (i.e., any psychotropic medication including methylphenidate, benzodiazepines, and mood stabilizers) within the 6 months preceding the enrolment.\n25. Patient participating or wishing to participate in any interventional clinical research (drug trial, medical device, non-drug trial).","ALL","8 Years","25 Years",{"count":148,"type":149},192,"ESTIMATED","INTERVENTIONAL",[152],"NA","Remarkable progress in paediatric cardiology and surgery have led to the substantial increase of congenital heart disease (CHD) survivors. Long-term outcomes in rare and complex CHD have become a critical priority as three major sources of morbidity have been identified in this population: neurodevelopmental sequelae, mental health issues and reduced exercise capacity. These challenges adversely affect their quality of life and constitute a major public health issue. We seek to evaluate the efficacy of the first integrative and holistic program in Neuro-Cardiac Health associating physical and psychological rehabilitation for children with rare CHD compared to the standard of care. Children randomly assigned to the intervention will undergo a 12-week neuro-cardiac intervention including home-based adaptive physical exercise, telehealth parent and child psycho-education and child computerized cognitive training, as well in-person individual sessions of intervention reinforcement. Parents will be actively involved and will receive personalized feedback and educational resources. Children assigned to the control group will receive the standard of care in congenital cardiology. Post-intervention effects will be measured after 12-months on several outcomes including health-related quality of life (HRQoL), trained and untrained cognitive skills, mental health outcomes and cardiovascular\u002Fphysical variables.",[155],"Congenital Heart Disease",[157,158],"Neuro-cardiac rehabilitation program","Quality of life","2026-07-07",{"date":161,"type":162},"2026-07-08","ACTUAL",{"date":164,"type":162},"2024-06-03",{"date":166,"type":149},"2028-06-03",{"name":5,"class":6},6]