Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases

Study Overview
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Brief Summary
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The investigators aim to measure the impact of a rehabilitation program in congenital cardiology in terms of health related quality of life. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer.

Detailed Description
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Adolescents and adults with congenital heart disease (CHD) have reduced exercise capacity compared to the general population, even for simple heart disease. Regular physical activity is known to reduce the risk of acquired heart disease. Cardiac rehabilitation programs have been largely developed to manage adult coronary and heart failure patients, which is not yet the case routinely in patients, adults and children, carriers of DC. The investigators assume that patients who participate in this program will improve their quality of life compared to controls. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer .

Official Title
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Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial

Conditions
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Adolescent, Heart Defects, Congenital, Young Adult

Intervention / Treatment
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* Other: Cardiac rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 13 to 25 years included With a congenital heart diseases (CHD) as defined in the international CHD classification. Recent (< 3 months) cardio-pulmonary exercise test (CPET)with maximum oxygen uptake (VO2max) <80% of theoretical values and/or first ventilatory anaerovic threshold (VAT) <55% of VO2max. Consent of the adult patient or the parents or legal guardians of the minor patient. Beneficiary of the social security scheme. Exclusion Criteria: Uncontrolled arrhythmia. Cardiac surgery planned during the rehabilitation program. Severe musculoskeletal disorders. Severe intellectual disability that does not allow the quality of life questionnaire to be completed. Pregnancy. Patient who already underwent cardiac rehabilitation in the last 24 months. All medical contraindications to perform a cardiorespiratory stress test. Uncontrolled heart failure (NYHA IV) Obesity (BMI > 30)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cardiac rehabilitation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Controls will have a regular follow-up without any intervention (no rehabilitation program) | |
| Active Comparator: Rehabilitaiton<br>Cardiac rehabilitation: Rehabilitation will have a regular follow-up with intervention (rehabilitation program) | Other: Cardiac rehabilitation<br>* Educational/Counseling/Training : Rehabilitation, , cardiovascular rehabilitation in congenital heart disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life. | Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12 | follow up of patients over 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen uptake (VO2max, ml/kg/min) |  | Month 0 and Month 12 | 
| ventilatory anaerobic threshold (VAT, ml/kg/min) |  | Month 0 and Month 12 | 
| knowledge of the disease | Disease knowledge questionnaire (Leuven questionnaire, 34 items, total range score from 0 to 100, a higher score indicating better knowledge) | Month 0 and Month 12 | 
| cardiac events | number of consultation in cardiology, number of hospitalization in cardiology, number of cardiovascular events | Month 0 and Month 12 | 
| physical activity scoring | Score of physical activity (Ricci and Gagnon questionnaire, 9 items, total range score from 6 to 45, higher score indicating a higher level of physical activity) | Month 0 and Month 12 | 
| functional NYHA class | NYHA functional class= New York Association functional class from the World Health Organization | Month 0 and Month 12 | 
| Cardiac output during exercise | Variation of cardiac output during exercise tests measured by impedance measurement (Physioflow) | Month 0 and Month12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient education as topic, Quality of life, Health Knowledge, Attitudes, Practice, cardiac rehabilitation, Congenital heart diseases, Heart defects, congenital, Adolescent, Young adult, Physical activity, Cardio-pulmonary exercice test, Oxygen uptake, Muscular deconditioning