Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases
QUALIREHAB
Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial
2 other identifiers
interventional
142
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 27, 2018
CompletedFirst Submitted
Initial submission to the registry
August 7, 2018
CompletedFirst Posted
Study publicly available on registry
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2022
CompletedJanuary 31, 2023
January 1, 2023
4.1 years
August 7, 2018
January 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
follow up of patients over 12 months
Secondary Outcomes (7)
Peak oxygen uptake (VO2max, ml/kg/min)
Month 0 and Month 12
ventilatory anaerobic threshold (VAT, ml/kg/min)
Month 0 and Month 12
knowledge of the disease
Month 0 and Month 12
cardiac events
Month 0 and Month 12
physical activity scoring
Month 0 and Month 12
- +2 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONControls will have a regular follow-up without any intervention (no rehabilitation program)
Rehabilitaiton
ACTIVE COMPARATORCardiac rehabilitation: Rehabilitation will have a regular follow-up with intervention (rehabilitation program)
Interventions
Educational/Counseling/Training : Rehabilitation, , cardiovascular rehabilitation in congenital heart disease
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Haut Lévêques - Bordeaux University Hospital
Bordeaux, 33000, France
Brest University Hospital
Brest, France
Gabriel Montpied Hospital- Clermont Ferrand University Hospital
Clermont-Ferrand, 63000, France
Grenoble Alpes University Hospital
Grenoble, 38000, France
Marie Lannelongue Hospital
Le Plessis-Robinson, 92350, France
Children and Mother Hospital - Limoges University Hospital
Limoges, 87000, France
La Timone- Public Assistance - Marseille hospitals
Marseille, 13000, France
Liberal Cabinet Massy
Massy, 91300, France
Arnaud de Villeneuve - University Hospital
Montpellier, 34 000, France
Nice University Hospital
Nice, France
Caremeau - Nimes University Hospital
Nîmes, 30000, France
Saint-Pierre Institute
Palavas-les-Flots, 34250, France
Necker - Sick Children Hospital - Paris
Paris, 75015, France
La Miletrie -Poitier University Hospital
Poitiers, 86000, France
Children Hospital - Toulouse University Hospital
Toulouse, 31000, France
Pasteur Clinic
Toulouse, 31000, France
Barbois Hospital - Nancy University Hospital
Vandœuvre-lès-Nancy, 54500, France
Related Publications (1)
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.
PMID: 30616811BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2018
First Posted
October 1, 2018
Study Start
July 27, 2018
Primary Completion
September 12, 2022
Study Completion
September 12, 2022
Last Updated
January 31, 2023
Record last verified: 2023-01