Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases

Heart Defects, Congenital Clinical Trial

— QUALIREHAB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690518
• Other study ID #: RECHMPL18_0039
• Secondary ID: 7576
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Adolescent
• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Diseases
• Young Adult

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	Vandœuvre-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