Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases
- Conditions
- Heart Defects, CongenitalAdolescentYoung Adult
- Registration Number
- NCT03690518
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
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
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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life. follow up of patients over 12 months Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12
- Secondary Outcome Measures
Name Time Method Peak oxygen uptake (VO2max, ml/kg/min) Month 0 and Month 12 ventilatory anaerobic threshold (VAT, ml/kg/min) Month 0 and Month 12 cardiac events Month 0 and Month 12 number of consultation in cardiology, number of hospitalization in cardiology, number of cardiovascular events
physical activity scoring Month 0 and Month 12 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)
Cardiac output during exercise Month 0 and Month12 Variation of cardiac output during exercise tests measured by impedance measurement (Physioflow)
functional NYHA class Month 0 and Month 12 NYHA functional class= New York Association functional class from the World Health Organization
knowledge of the disease Month 0 and Month 12 Disease knowledge questionnaire (Leuven questionnaire, 34 items, total range score from 0 to 100, a higher score indicating better knowledge)
Trial Locations
- Locations (17)
Haut Lévêques - Bordeaux University Hospital
🇫🇷Bordeaux, France
Brest University Hospital
🇫🇷Brest, France
Gabriel Montpied Hospital- Clermont Ferrand University Hospital
🇫🇷Clermont-Ferrand, France
Grenoble Alpes University Hospital
🇫🇷Grenoble, France
Marie Lannelongue Hospital
🇫🇷Le Plessis-Robinson, France
Children and Mother Hospital - Limoges University Hospital
🇫🇷Limoges, France
La Timone- Public Assistance - Marseille hospitals
🇫🇷Marseille, France
Liberal Cabinet Massy
🇫🇷Massy, France
Arnaud de Villeneuve - University Hospital
🇫🇷Montpellier, France
Nice University Hospital
🇫🇷Nice, France
Scroll for more (7 remaining)Haut Lévêques - Bordeaux University Hospital🇫🇷Bordeaux, France