Heart Defects, CongenitalQUALIREHABNCT03690518
Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases
A study testing Cardiac rehabilitation in people with Heart Defects, Congenital and Adolescent, run by University Hospital, Montpellier at 17 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Heart Defects, Congenital, Adolescent, Young Adult
- What is being tested?
- Cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 17 sitesFrance
- Study dates
- 27 Jul 2018to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- All medical contraindications to perform a cardiorespiratory stress test.
- Uncontrolled heart failure (NYHA IV)
- Obesity (BMI > 30)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Haut Lévêques - Bordeaux University Hospital
Bordeaux, 33000
Brest University Hospital
Brest
Gabriel Montpied Hospital- Clermont Ferrand University Hospital
Clermont-Ferrand, 63000
Grenoble Alpes University Hospital
Grenoble, 38000
Marie Lannelongue Hospital
Le Plessis-Robinson, 92350
Children and Mother Hospital - Limoges University Hospital
Limoges, 87000
La Timone- Public Assistance - Marseille hospitals
Marseille, 13000
Liberal Cabinet Massy
Massy, 91300
Arnaud de Villeneuve - University Hospital
Montpellier, 34 000
Nice University Hospital
Nice
Caremeau - Nimes University Hospital
Nîmes, 30000
Saint-Pierre Institute
Palavas-les-Flots, 34250
Necker - Sick Children Hospital - Paris
Paris, 75015
La Miletrie -Poitier University Hospital
Poitiers, 86000
Children Hospital - Toulouse University Hospital
Toulouse, 31000
Pasteur Clinic
Toulouse, 31000
Barbois Hospital - Nancy University Hospital
Vandœuvre-lès-Nancy, 54500
About this study
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
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.
Read the 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 .
- Conditions
- Heart Defects, Congenital, Adolescent, Young Adult
- Being tested
- Cardiac rehabilitation
- 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
- Medical subject headings
- Heart Defects, Congenital, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
Educational/Counseling/Training : Rehabilitation, , cardiovascular rehabilitation in congenital heart disease
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Controls will have a regular follow-up without any intervention (no rehabilitation program) |
| Rehabilitaiton | Active comparator | Cardiac rehabilitation: Rehabilitation will have a regular follow-up with intervention (rehabilitation program) Receives: Other: Cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: follow up of patients over 12 months
Secondary outcomes (7)
Peak oxygen uptake (VO2max, ml/kg/min)
Measured: Month 0 and Month 12
ventilatory anaerobic threshold (VAT, ml/kg/min)
Measured: Month 0 and Month 12
knowledge of the disease
Disease knowledge questionnaire (Leuven questionnaire, 34 items, total range score from 0 to 100, a higher score indicating better knowledge)
Measured: Month 0 and Month 12
cardiac events
number of consultation in cardiology, number of hospitalization in cardiology, number of cardiovascular events
Measured: Month 0 and Month 12
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)
Measured: Month 0 and Month 12
functional NYHA class
NYHA functional class= New York Association functional class from the World Health Organization
Measured: Month 0 and Month 12
Cardiac output during exercise
Variation of cardiac output during exercise tests measured by impedance measurement (Physioflow)
Measured: Month 0 and Month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start27 Jul 2018
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cardiac rehabilitation
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690518
- Sponsor's protocol ID
- RECHMPL18_0039
- Other IDs
- 7576
- Acronym
- QUALIREHAB
- Status last verified
- Jan 2023
- First submitted
- 7 Aug 2018
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30616811Andrianoely M, Desir A, Huguet H, Picot MC, Audie M, Lagorce S, Venna A, Rheault M, Batterton MK, Weissland T, Marguin G, Auer A, Guillaumont S, Amedro P; QUALIREHAB Study Group *. Determinants and Implementation of Hybrid Cardiac Rehabilitation in Adolescents and Young Adults With Congenital Heart Disease: Insight From the QUALIREHAB Study. J Am Heart Assoc. 2026 Jul 21;15(14):e049698. doi: 10.1161/JAHA.126.049698. Epub 2026 Jul 10.
PubMed 42432442
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03690518
- Acronym / sponsor ID
- QUALIREHAB / RECHMPL18_0039
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cardiac rehabilitation
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Controls will have a regular follow-up without any intervention (no rehabilitation program) |
| Rehabilitaiton | Active comparator | Other: Cardiac rehabilitationCardiac rehabilitation: Rehabilitation will have a regular follow-up with intervention (rehabilitation program) |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationEducational/Counseling/Training : Rehabilitation, , cardiovascular rehabilitation in congenital heart disease | Other | Rehabilitaiton |
Primary outcome
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
7 secondary outcomes
Peak oxygen uptake (VO2max, ml/kg/min)
Time frame: Month 0 and Month 12
ventilatory anaerobic threshold (VAT, ml/kg/min)
Time frame: Month 0 and Month 12
knowledge of the disease
Time frame: Month 0 and Month 12
cardiac events
Time frame: Month 0 and Month 12
physical activity scoring
Time frame: Month 0 and Month 12
functional NYHA class
Time frame: Month 0 and Month 12
Cardiac output during exercise
Time frame: Month 0 and Month12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 30616811Amedro 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.
- Derived from this study: PubMed 42432442Andrianoely M, Desir A, Huguet H, Picot MC, Audie M, Lagorce S, Venna A, Rheault M, Batterton MK, Weissland T, Marguin G, Auer A, Guillaumont S, Amedro P; QUALIREHAB Study Group *. Determinants and Implementation of Hybrid Cardiac Rehabilitation in Adolescents and Young Adults With Congenital Heart Disease: Insight From the QUALIREHAB Study. J Am Heart Assoc. 2026 Jul 21;15(14):e049698. doi: 10.1161/JAHA.126.049698. Epub 2026 Jul 10.
Related trials for Heart Defects, Congenital
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Not yet recruitingObservational study
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Cardiac Abnormalities, Nutrient Intake
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation in people with Heart Defects, Congenital and Adolescent, run by University Hospital, Montpellier at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690518, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.