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| Name | Class |
|---|---|
| Saint Pierre Institute - Palavas les Flots | UNKNOWN |
| University Hospital, Toulouse | OTHER |
| University Hospital, Bordeaux | OTHER |
| Hôpital Necker-Enfants Malades |
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The QUALIMYORYTHM trial is a multicentre controlled study, aiming to assess health-related quality of life (HRQoL) of 107 children aged 6 to 18 years old with inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or inherited cardiomyopathies (hypertrophic, dilated, or restrictive cardiomyopathy), and to compare the results to those of 107 age and gender-matched healthy subjects. The secondary objective is to assess, in this population, the HRQoL according to disease characteristics, level of physical activity, exercise capacity, and socio-demographic data. Participants will wear a fitness tracker for 2 weeks.
Advances in paediatric cardiology has improved the prognosis of children with inherited cardiac disorders. However, quality of life and physical activity have been scarcely analysed in children with inherited cardiac arrhythmia or inherited cardiomyopathies. Moreover, current guidelines on the eligibility of young athletes with inherited cardiac disorders for sports participation mainly rely on expert opinions and remain controversial.
The QUALIMYORYTHM trial is a multicentre controlled study. The main objective is to compare health-related quality of life (HRQoL) of children aged 6 to 18 years old with inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or inherited cardiomyopathies (hypertrophic, dilated, or restrictive cardiomyopathy), to that of age and gender-matched healthy subjects. The secondary objective is to assess, in this population, HRQoL according to the disease clinical and genetic characteristics, the level of physical activity and motivation for sports, the exercise capacity (VO2max), and the socio-demographic data. Participants will wear a fitness tracker (actimeter watch) for 2 weeks. A total of 214 children are required to observe a significant difference of 7 ± 15 points in the PedsQL, with a power of 90% and an alpha risk of 5%.
The QUALIMYORYTHM trial intends to improve the level of evidence for future guidelines on sports eligibility in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac disease | Experimental | Children aged of 6 to 18 years old with an inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or those with an inherited cardiomyopathy (hypertrophic, dilated, or restrictive cardiomyopathy). |
|
| Control group | Sham Comparator | Children aged 6 to 18 years old referred to the paediatric cardiology consultation who were classified in the control group after a completely normal check-up, including physical examination, electrocardiogram, and echocardiography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other | MRI cardiac |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total score of health-reported quality of life self questionnaire | PedsQL questionnaire | baseline (1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| The metabolic equivalent of task | measured by the wearable actimeter device. | during 14 days after inclusion |
| physical activity level | Ricci and Gagnon questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Arnaud de Villeneuve | Montpellier | Occitanie | 34090 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34321045 | Background | Amedro P, Werner O, Abassi H, Boisson A, Souilla L, Guillaumont S, Calderon J, Requirand A, Vincenti M, Pommier V, Matecki S, De La Villeon G, Lavastre K, Lacampagne A, Picot MC, Beyler C, Delclaux C, Dulac Y, Guitarte A, Charron P, Denjoy-Urbain I, Probst V, Baruteau AE, Chevalier P, Di Filippo S, Thambo JB, Bonnet D, Pasquie JL. Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods. Health Qual Life Outcomes. 2021 Jul 28;19(1):187. doi: 10.1186/s12955-021-01825-6. | |
| 36712265 |
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| OTHER |
| Hopital Lariboisière | OTHER |
| Nantes University Hospital | OTHER |
| Hospices Civils de Lyon | OTHER |
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| baseline (1 day) |
| Motivation towards health-oriented physical activity | EMAPS motivation scale | baseline (1 day) |
| Exercise capacity | Cardiopulmonary exercise test with VO2max assessment | baseline (1 day) |
| Myocardial morphologic assessment | cardiac MRI | baseline (1 day) |
| Background |
| Souilla L, Avesani M, Boisson A, Requirand A, Matecki S, Vincenti M, Werner O, De La Villeon G, Pommier V, Pasquie JL, Guillaumont S, Amedro P. Cardiorespiratory fitness, muscle fitness, and physical activity in children with long QT syndrome: A prospective controlled study. Front Cardiovasc Med. 2023 Jan 11;9:1081106. doi: 10.3389/fcvm.2022.1081106. eCollection 2022. |
| 38997778 | Background | Souilla L, Guillaumont S, Auer A, Metzler G, Requirand A, Vincenti M, De La Villeon G, Pasquie JL, Mottet D, Amedro P. Cardiac rehabilitation in children and adolescents with long QT syndrome: the RYTHMO'FIT pilot study. BMC Sports Sci Med Rehabil. 2024 Jul 12;16(1):152. doi: 10.1186/s13102-024-00941-2. |
| 39998828 | Result | Souilla L, Werner O, Huguet H, Gavotto A, Vincenti M, Pasquie JL, De La Villeon G, Guillaumont S, Pommier V, Matecki S, Baruteau AE, Beyler C, Delclaux C, Denjoy I, Charron P, Chevalier P, Deliniere A, Andrianoely M, Cornuault L, Besnard-Neyraud C, Sacher F, Reant P, Mottet D, Picot MC, Amedro P; Quality of Life in Children With Inherited Cardiomyopathy or Arrhythmia (QUALIMYORYTHM) Study Group. Cardiopulmonary Fitness and Physical Activity Among Children and Adolescents With Inherited Cardiac Disease. JAMA Netw Open. 2025 Feb 3;8(2):e2461795. doi: 10.1001/jamanetworkopen.2024.61795. |
| ID | Term |
|---|---|
| D008133 | Long QT Syndrome |
| D053840 | Brugada Syndrome |
| D000098850 | Polymorphic Catecholaminergic Ventricular Tachycardia |
| D019571 | Arrhythmogenic Right Ventricular Dysplasia |
| D002312 | Cardiomyopathy, Hypertrophic |
| D002311 | Cardiomyopathy, Dilated |
| D002313 | Cardiomyopathy, Restrictive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D030342 | Genetic Diseases, Inborn |
| D017180 | Tachycardia, Ventricular |
| D013610 | Tachycardia |
| D009202 | Cardiomyopathies |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006332 | Cardiomegaly |
| D000083083 | Laminopathies |
| D001519 | Behavior |
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