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

Primary Purpose

Heart Defects, Congenital, Adolescent, Young Adult

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac rehabilitation
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Defects, Congenital focused on measuring 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

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Haut Lévêques - Bordeaux University Hospital
  • Brest University Hospital
  • Gabriel Montpied Hospital- Clermont Ferrand University Hospital
  • Grenoble Alpes University Hospital
  • Marie Lannelongue Hospital
  • Children and Mother Hospital - Limoges University Hospital
  • La Timone- Public Assistance - Marseille hospitals
  • Liberal Cabinet Massy
  • Arnaud de Villeneuve - University Hospital
  • Nice University Hospital
  • Caremeau - Nimes University Hospital
  • Saint-Pierre Institute
  • Necker - Sick Children Hospital - Paris
  • La Miletrie -Poitier University Hospital
  • Children Hospital - Toulouse University Hospital
  • Pasteur Clinic
  • Barbois Hospital - Nancy University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Rehabilitaiton

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Peak oxygen uptake (VO2max, ml/kg/min)
ventilatory anaerobic threshold (VAT, ml/kg/min)
knowledge of the disease
Disease knowledge questionnaire (Leuven questionnaire, 34 items, total range score from 0 to 100, a higher score indicating better knowledge)
cardiac events
number of consultation in cardiology, number of hospitalization in cardiology, number of cardiovascular events
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)
functional NYHA class
NYHA functional class= New York Association functional class from the World Health Organization
Cardiac output during exercise
Variation of cardiac output during exercise tests measured by impedance measurement (Physioflow)

Full Information

First Posted
August 7, 2018
Last Updated
January 30, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03690518
Brief Title
Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2018 (Actual)
Primary Completion Date
September 12, 2022 (Actual)
Study Completion Date
September 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital, Adolescent, 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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cardiac rehabilitation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Controls will have a regular follow-up without any intervention (no rehabilitation program)
Arm Title
Rehabilitaiton
Arm Type
Active Comparator
Arm Description
Cardiac rehabilitation: Rehabilitation will have a regular follow-up with intervention (rehabilitation program)
Intervention Type
Other
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
Educational/Counseling/Training : Rehabilitation, , cardiovascular rehabilitation in congenital heart disease
Primary Outcome Measure Information:
Title
Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.
Description
Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12
Time Frame
follow up of patients over 12 months
Secondary Outcome Measure Information:
Title
Peak oxygen uptake (VO2max, ml/kg/min)
Time Frame
Month 0 and Month 12
Title
ventilatory anaerobic threshold (VAT, ml/kg/min)
Time Frame
Month 0 and Month 12
Title
knowledge of the disease
Description
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
Title
cardiac events
Description
number of consultation in cardiology, number of hospitalization in cardiology, number of cardiovascular events
Time Frame
Month 0 and Month 12
Title
physical activity scoring
Description
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
Title
functional NYHA class
Description
NYHA functional class= New York Association functional class from the World Health Organization
Time Frame
Month 0 and Month 12
Title
Cardiac output during exercise
Description
Variation of cardiac output during exercise tests measured by impedance measurement (Physioflow)
Time Frame
Month 0 and Month12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Haut Lévêques - Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Brest University Hospital
City
Brest
Country
France
Facility Name
Gabriel Montpied Hospital- Clermont Ferrand University Hospital
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Grenoble Alpes University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Marie Lannelongue Hospital
City
Le Plessis-Robinson
ZIP/Postal Code
92350
Country
France
Facility Name
Children and Mother Hospital - Limoges University Hospital
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
La Timone- Public Assistance - Marseille hospitals
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Liberal Cabinet Massy
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Arnaud de Villeneuve - University Hospital
City
Montpellier
ZIP/Postal Code
34 000
Country
France
Facility Name
Nice University Hospital
City
Nice
Country
France
Facility Name
Caremeau - Nimes University Hospital
City
Nîmes
ZIP/Postal Code
30000
Country
France
Facility Name
Saint-Pierre Institute
City
Palavas-les-Flots
ZIP/Postal Code
34250
Country
France
Facility Name
Necker - Sick Children Hospital - Paris
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
La Miletrie -Poitier University Hospital
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Children Hospital - Toulouse University Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Pasteur Clinic
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Barbois Hospital - Nancy University Hospital
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30616811
Citation
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.
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Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases

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