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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03690518
Other study ID # RECHMPL18_0039
Secondary ID 7576
Status Completed
Phase N/A
First received
Last updated
Start date July 27, 2018
Est. completion date September 12, 2022

Study information

Verified date January 2023
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 142
Est. completion date September 12, 2022
Est. primary completion date September 12, 2022
Accepts healthy volunteers No
Gender All
Age group 13 Years to 25 Years
Eligibility 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


Intervention

Other:
Cardiac rehabilitation
Educational/Counseling/Training : Rehabilitation, , cardiovascular rehabilitation in congenital heart disease

Locations

Country Name City State
France 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 Caremeau - Nimes University Hospital Nîmes
France Saint-Pierre Institute Palavas-les-Flots
France Necker - Sick Children Hospital - Paris Paris
France La Miletrie -Poitier University Hospital Poitiers
France Children Hospital - Toulouse University Hospital Toulouse
France Pasteur Clinic Toulouse
France Barbois Hospital - Nancy University Hospital VandÅ“uvre-lès-Nancy

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Peak oxygen uptake (VO2max, ml/kg/min) Month 0 and Month 12
Secondary ventilatory anaerobic threshold (VAT, ml/kg/min) Month 0 and Month 12
Secondary 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
Secondary cardiac events number of consultation in cardiology, number of hospitalization in cardiology, number of cardiovascular events Month 0 and Month 12
Secondary 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
Secondary functional NYHA class NYHA functional class= New York Association functional class from the World Health Organization Month 0 and Month 12
Secondary Cardiac output during exercise Variation of cardiac output during exercise tests measured by impedance measurement (Physioflow) Month 0 and Month12
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