Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases

Not Applicable

Completed

• Conditions: Heart Defects, Congenital; Adolescent; Young Adult
• Interventions: Other: Cardiac rehabilitation

• 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 .

Study Timeline

• Study Start: 2018-07-27
• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Primary Completion: 2022-09-12
• Study Completion: 2022-09-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitaiton	Cardiac rehabilitation	Cardiac rehabilitation: Rehabilitation will have a regular follow-up with intervention (rehabilitation program)

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)

Caremeau - Nimes University Hospital; 🇫🇷 Nîmes, France

Pasteur Clinic; 🇫🇷 Toulouse, France

Haut Lévêques - Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Gabriel Montpied Hospital- Clermont Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France

Brest University Hospital; 🇫🇷 Brest, France

Marie Lannelongue Hospital; 🇫🇷 Le Plessis-Robinson, France

La Timone- Public Assistance - Marseille hospitals; 🇫🇷 Marseille, France

Necker - Sick Children Hospital - Paris; 🇫🇷 Paris, France

Grenoble Alpes University Hospital; 🇫🇷 Grenoble, France

Children and Mother Hospital - Limoges University Hospital; 🇫🇷 Limoges, France

Liberal Cabinet Massy; 🇫🇷 Massy, France

Nice University Hospital; 🇫🇷 Nice, France

La Miletrie -Poitier University Hospital; 🇫🇷 Poitiers, France

Children Hospital - Toulouse University Hospital; 🇫🇷 Toulouse, France

Saint-Pierre Institute; 🇫🇷 Palavas-les-Flots, France

Barbois Hospital - Nancy University Hospital; 🇫🇷 Vandœuvre-lès-Nancy, France

Arnaud de Villeneuve - University Hospital; 🇫🇷 Montpellier, France