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

Sponsor
University Hospital, Bordeaux
Study ID
NCT05670132
Status
Recruiting
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Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
8 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Neurocardiac rehabilitation program — OTHER
    Patients receiving a neurocardiac rehabilitation program for 12 weeks.
  • Standard of care — OTHER
    No intervention during the neurocardiac rehabilitation program

Study Details

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.

Key Dates

First listed
Jan 4, 2023
Start date
Jun 3, 2024
Status verified
Jul 2026
Primary completion
Jun 3, 2028
Completion
Jun 3, 2028

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Neurocardiac rehabilitation program
    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.
  • Active Comparator: Standard of care
    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

Primary Outcome Measure

Total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire [ Time Frame: between Month 0 and Month 12 ]

Central Contacts

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