An interventional study of Cardiac rehabilitation in Heart Defects, Congenital, Adolescent and Young Adult, sponsored by University Hospital, Montpellier. Completed at 17 sites in France. Open to participants aged 13 Years to 25 Years. Per ClinicalTrials.gov, last updated 2023-01-31.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
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.
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 .
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 142 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 224 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Controls will have a regular follow-up without any intervention (no rehabilitation program)
Cardiac rehabilitation: Rehabilitation will have a regular follow-up with intervention (rehabilitation program)
Other: Cardiac rehabilitation
Educational/Counseling/Training : Rehabilitation, , cardiovascular rehabilitation in congenital heart disease
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
Time frame: follow up of patients over 12 months
Peak oxygen uptake (VO2max, ml/kg/min)
Time frame: Month 0 and Month 12
ventilatory anaerobic threshold (VAT, ml/kg/min)
Time frame: Month 0 and Month 12
knowledge of the disease
Disease knowledge questionnaire (Leuven questionnaire, 34 items, total range score from 0 to 100, a higher score indicating better knowledge)
Time frame: Month 0 and Month 12
cardiac events
number of consultation in cardiology, number of hospitalization in cardiology, number of cardiovascular events
Time frame: Month 0 and Month 12
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)
Time frame: Month 0 and Month 12
functional NYHA class
NYHA functional class= New York Association functional class from the World Health Organization
Time frame: Month 0 and Month 12
Cardiac output during exercise
Variation of cardiac output during exercise tests measured by impedance measurement (Physioflow)
Time frame: Month 0 and Month12
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier