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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 25
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Belgium
Saint-Luc University Hospital
NOT_YET_RECRUITING
Brussels
France
University Hospital of Montpellier - Arnaud de Villeneuve Hospital
RECRUITING
Montpellier
Saint-Pierre Institute
RECRUITING
Palavas-les-flots
University Hospital of Bordeaux - Haut-Levêque Hospital
RECRUITING
Pessac
Germany
Deutsches Herzzentrum München
NOT_YET_RECRUITING
München
Contact Information
Primary
Pascal AMEDRO, MD,PhD
pascal.amedro@chu-bordeaux.fr
05 57 65 61 09
Backup
Johanna CALDERON, PhD
johanna.calderon@inserm.fr
Time Frame
Start Date: 2024-06-03
Estimated Completion Date: 2027-06-03
Participants
Target number of participants: 290
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov