Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)
Congenital Heart Disease
About this trial
This is an interventional prevention trial for Congenital Heart Disease focused on measuring Neuro-cardiac rehabilitation program, Quality of life
Eligibility Criteria
Inclusion Criteria: Patient with a CHD of moderate to great complexity as defined in the 2019 AHA/ACC guidelines (Appendix 2)85. History of cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life. Age between 8 and 25 years at the time of enrolment. Parental or legal guardian's consent for minors (<18 years) and personal consent for adults. Social security affiliation (for France only) Exclusion Criteria: Unstable and/or severe heart failure: severe heart failure (class IV NYHA functional class), recent decompensated heart failure requiring hospitalisation and/or any significant change in medication (< 3 months before enrolment), systolic ventricle dysfunction (left ventricle or systemic ventricle ejection fraction < 50%)82. Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest <85%, and/or SpO2 at exercise <80%, and/or patient requiring oxygen therapy. Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology83. Significant systolic right ventricle (sRV) hypertension (sRV pressure > 50% of systemic systolic pressure). Uncontrolled arrhythmia: symptomatic treated or untreated arrhythmia at rest and/or exercise, treated arrhythmia with sustained supraventricular or ventricular tachycardia on ECG monitoring or during exercise and/or CPET, occurrence or aggravation of any supraventricular or ventricular arrhythmia during exercise and/or CPET. Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and/or CPET. Uncontrolled arterial hypertension at rest (e.g. if the blood pressure at rest during the consultation >140/90 mmHg in adults, >95th percentile in children84). Acute or recent (< 3 months) myocarditis and pericarditis. Symptomatic aortic or sub-aortic stenosis. Non-corrected coarctation of the aorta (surgical or catheter-based repair) with a clinical systolic gradient > 20 mmHg. Dilatation of the aorta (aortic root > 40 mm in adults, > 2 Z-score in children85 (http://www.parameterz.com/sites/aortic-root). Severe hypertrophic obstructive cardiomyopathy diagnosed by non-echocardiography. Acute systemic illness. Recent (<3 months) intracardiac thrombus, embolism, or thrombophlebitis. Inability to follow instructions and/or complete the questionnaires, as determined by the investigator. 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. 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). Patient with a previously diagnosed severe psychiatric disorder requiring hospitalization and/or continuous specialized care by a psychiatrist, as determined by the investigator. Patients who benefited from a cardiac rehabilitation within the 12 months preceding the enrolment. Patients who benefited from a computerized executive function or attention training such as Cogmed Working Memory Program within the 12 months preceding the enrolment. For female patients: pregnancy, pregnancy plan, or breastfeeding woman following questioning of the patient. Patients deprived of liberty due to an ongoing legal procedure, adult's patient under guardianship or curatorship or unable to personally express their consent. Any other clinical and/or pharmacological treatment that is believed to interfere with the study or the optimal clinical care. 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. Patient participating or wishing to participate in any interventional clinical research (drug trial, medical device, non-drug trial).
Sites / Locations
- Saint-Luc University Hospital
- University Hospital of Montpellier - Arnaud de Villeneuve Hospital
- Saint-Pierre Institute
- University Hospital of Bordeaux - Haut-Levêque Hospital
- Deutsches Herzzentrum München
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Neurocardiac rehabilitation program
Standard of care
The home-based neuro-cardiac rehabilitation program will consist of weekly sessions of neuro-cardiac training during 12 weeks at home. 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 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 30/45-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.
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