Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)

Neurodevelopmental and mental health issues and reduced exercise capacity are the mostfrequent long‐term morbidities in youth with CHD. These problems worsen with age and playa critical role in reducing the quality of life of patients and their families. TheQUALI‐NEUROREHAB CHD multicentre, randomized controlled trial seeks to test the efficacyof an innovative home‐based neuro‐cardiac intervention to improve physical and mentalhealth of children, adolescents and young adults with rare CHD, as assessed by thepatients themselves using patient‐reported outcomes and standardized assessments.Outcomes relate to changes in scores for health‐related quality of life (HRQoL, primaryoutcome measure), neurodevelopmental and mental health outcomes, and cardiopulmonaryexercise test parameters, 12 months post‐enrolment, in patients with rare CHD aged 8 to25 years old. This is a two‐arm parallel design study: intervention versus control.Intervention using the neuro‐cardiac rehabilitation program will be the active arm.Standard of care will be used for the control group and involves normal cardiologyconsultations and follow‐up without intervention programs on physical activity orneurocognitive training. The intervention group will include 12 weeks of neuro‐cardiactraining, comprised of at‐home adaptive physical exercise, telehealth consultations andcomputerized neurocognitive training as well in‐person individual sessions ofintervention reinforcement. We hypothesize an increase in the overall HRQoL score of 6 ±14 points (over 100). With a 90% power, a bilateral alpha risk of 5%, and potentially 20%of loss to follow‐up and/or missing data on the primary outcome, we need to randomize 145patients to each group (N= 290, overall). Analysis will be performed using intent totreat (ITT) approach. We predict significant positive changes in quality of life, mentaland physical health scores in patients who will be assigned to the neuro‐cardiacintervention (active arm). If this intervention is effective, it can have critical publichealth implications for the organization and modalities of care for children with rareCHD in Europe. A neuro‐cardiac rehabilitation programme tailored to the specificchallenges of individuals with rare CHD would improve patient care pathways across majorcenters in Europe.