Heart Defects, Congenital Clinical Trial
— QUALIREHABOfficial title:
Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial
Verified date | January 2023 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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
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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