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/physical variables.
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.
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).
Parallel
Neurocardiac rehabilitation program
Other interventionPatients receiving a neurocardiac rehabilitation program for 12 weeks.
Standard of care
Other interventionNo intervention during the neurocardiac rehabilitation program
Total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire
Change in the self-reported total score of the PedsQL 4.0 questionnaire between baseline (Month 0) and the end of follow-up (Month 12) in both groups.
Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL) for paediatric patients
Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)
Behaviour Rating Inventory of Executive Function (BRIEF) scale scores
BRIEF (8-18 years) and BRIEF-A (older than 18 years) These scales make it possible to identify executive dysfunctions that have an impact on daily life. BRIEF assesses behaviours based on questions grouped into 8 scales: inhibition, flexibility, emotional control, initiation, material organization, working memory, planning/organization, and control. For the BRIEF-A (18 years and +), 9 scales are available and those yield the same indices and general composite score.
Wisconsin Card Sorting Test scale score
This test measures higher-order executive functioning including planning, anticipation, and cognitive flexibility.
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