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Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases (QUALIREHAB)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Heart Defects, Congenital
Young Adult
Adolescent

Treatments

Other: Cardiac rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT03690518
RECHMPL18_0039
7576 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 .

Enrollment

142 patients

Sex

All

Ages

13 to 25 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

142 participants in 2 patient groups

Control
No Intervention group
Description:
Controls will have a regular follow-up without any intervention (no rehabilitation program)
Rehabilitaiton
Active Comparator group
Description:
Cardiac rehabilitation: Rehabilitation will have a regular follow-up with intervention (rehabilitation program)
Treatment:
Other: Cardiac rehabilitation

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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