Clinical trial NCT03690518: Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases
Official title: Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Defects, Congenital
Adolescent
Young Adult
Keywords: cardiac rehabilitation
Congenital heart diseases
Heart defects, congenital
Adolescent
Young adult
Physical activity
Cardio-pulmonary exercice test
Oxygen uptake
Muscular deconditioning
Patient education as topic
Quality of life
Health Knowledge, Attitudes, Practice
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 142
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cardiac rehabilitation
Primary purpose: OTHER

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 .

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.
timeFrame: follow up of patients over 12 months
Secondary outcomes:
measure: Peak oxygen uptake (VO2max, ml/kg/min)
timeFrame: Month 0 and Month 12
measure: ventilatory anaerobic threshold (VAT, ml/kg/min)
timeFrame: Month 0 and Month 12
measure: knowledge of the disease
timeFrame: Month 0 and Month 12
measure: cardiac events
timeFrame: Month 0 and Month 12
measure: physical activity scoring
timeFrame: Month 0 and Month 12
measure: functional NYHA class
timeFrame: Month 0 and Month 12
measure: Cardiac output during exercise
timeFrame: Month 0 and Month12
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Haut Lévêques - Bordeaux University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Clermont-Ferrand
country: France
facility: Gabriel Montpied Hospital- Clermont Ferrand University Hospital
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital
city: Le Plessis-Robinson
country: France
facility: Marie Lannelongue Hospital
city: Limoges
country: France
facility: Children and Mother Hospital - Limoges University Hospital
city: Marseille
country: France
facility: La Timone- Public Assistance - Marseille hospitals
city: Massy
country: France
facility: Liberal Cabinet Massy
city: Montpellier
country: France
facility: Arnaud de Villeneuve - University Hospital
city: Nice
country: France
facility: Nice University Hospital
city: Nîmes
country: France
facility: Caremeau - Nimes University Hospital
city: Palavas-les-Flots
country: France
facility: Saint-Pierre Institute
city: Paris
country: France
facility: Necker - Sick Children Hospital - Paris
city: Poitiers
country: France
facility: La Miletrie -Poitier University Hospital
city: Toulouse
country: France
facility: Children Hospital - Toulouse University Hospital
city: Toulouse
country: France
facility: Pasteur Clinic
city: Vandœuvre-lès-Nancy
country: France
facility: Barbois Hospital - Nancy University Hospital
Study officials:
References:
citation: Amedro P, Gavotto A, Legendre A, Lavastre K, Bredy C, De La Villeon G, Matecki S, Vandenberghe D, Ladeveze M, Bajolle F, Bosser G, Bouvaist H, Brosset P, Cohen L, Cohen S, Corone S, Dauphin C, Dulac Y, Hascoet S, Iriart X, Ladouceur M, Mace L, Neagu OA, Ovaert C, Picot MC, Poirette L, Sidney F, Soullier C, Thambo JB, Combes N, Bonnet D, Guillaumont S. Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: The QUALI-REHAB study rationale, design and methods. Int J Cardiol. 2019 May 15;283:112-118. doi: 10.1016/j.ijcard.2018.12.050. Epub 2018 Dec 20.