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Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases

Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03690518
Acronym
QUALIREHAB
Enrollment
142
Registered
2018-10-01
Start date
2018-07-27
Completion date
2022-09-12
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent, Heart Defects, Congenital, 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

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 .

Interventions

OTHERCardiac rehabilitation

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Cardiac rehabilitation

Eligibility

Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.follow up of patients over 12 monthsEvolution of the PedsQL 4.0 self-reported scores from month 0 to month 12

Secondary

MeasureTime frameDescription
ventilatory anaerobic threshold (VAT, ml/kg/min)Month 0 and Month 12
knowledge of the diseaseMonth 0 and Month 12Disease knowledge questionnaire (Leuven questionnaire, 34 items, total range score from 0 to 100, a higher score indicating better knowledge)
cardiac eventsMonth 0 and Month 12number of consultation in cardiology, number of hospitalization in cardiology, number of cardiovascular events
Peak oxygen uptake (VO2max, ml/kg/min)Month 0 and Month 12
functional NYHA classMonth 0 and Month 12NYHA functional class= New York Association functional class from the World Health Organization
Cardiac output during exerciseMonth 0 and Month12Variation of cardiac output during exercise tests measured by impedance measurement (Physioflow)
physical activity scoringMonth 0 and Month 12Score 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026