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Completed

NCT Number: NCT03690518

Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases

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.

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Key information

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haut Lévêques - Bordeaux University Hospital, Bordeaux, France

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cardiac rehabilitation

Other

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

Primary outcomes

  1. Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.

    Time frame: follow up of patients over 12 months

    Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12

Secondary outcomes

  1. Peak oxygen uptake (VO2max, ml/kg/min)

    Time frame: Month 0 and Month 12

  2. ventilatory anaerobic threshold (VAT, ml/kg/min)

    Time frame: Month 0 and Month 12

  3. knowledge of the disease

    Time frame: Month 0 and Month 12

    Disease knowledge questionnaire (Leuven questionnaire, 34 items, total range score from 0 to 100, a higher score indicating better knowledge)

  4. cardiac events

    Time frame: Month 0 and Month 12

    number of consultation in cardiology, number of hospitalization in cardiology, number of cardiovascular events

  5. physical activity scoring

    Time frame: Month 0 and Month 12

    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)

  6. functional NYHA class

    Time frame: Month 0 and Month 12

    NYHA functional class= New York Association functional class from the World Health Organization

  7. Cardiac output during exercise

    Time frame: Month 0 and Month12

    Variation of cardiac output during exercise tests measured by impedance measurement (Physioflow)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: QUALIREHAB

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2018
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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