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
Abstract Background Advances in paediatric cardiology have improved the prognosis of children with inherited cardiac disorders. However, health-related quality of life (QoL) and physical activity have been scarcely analysed in children with inherited cardiac arrhythmia or inherited cardiomyopathy. M...
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2021-07-01
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Series: | Health and Quality of Life Outcomes |
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Online Access: | https://doi.org/10.1186/s12955-021-01825-6 |
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Article |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Pascal Amedro Oscar Werner Hamouda Abassi Aymeric Boisson Luc Souilla Sophie Guillaumont Johanna Calderon Anne Requirand Marie Vincenti Victor Pommier Stefan Matecki Gregoire De La Villeon Kathleen Lavastre Alain Lacampagne Marie-Christine Picot Constance Beyler Christophe Delclaux Yves Dulac Aitor Guitarte Philippe Charron Isabelle Denjoy-Urbain Vincent Probst Alban-Elouen Baruteau Philippe Chevalier Sylvie Di Filippo Jean-Benoit Thambo Damien Bonnet Jean-Luc Pasquie |
spellingShingle |
Pascal Amedro Oscar Werner Hamouda Abassi Aymeric Boisson Luc Souilla Sophie Guillaumont Johanna Calderon Anne Requirand Marie Vincenti Victor Pommier Stefan Matecki Gregoire De La Villeon Kathleen Lavastre Alain Lacampagne Marie-Christine Picot Constance Beyler Christophe Delclaux Yves Dulac Aitor Guitarte Philippe Charron Isabelle Denjoy-Urbain Vincent Probst Alban-Elouen Baruteau Philippe Chevalier Sylvie Di Filippo Jean-Benoit Thambo Damien Bonnet Jean-Luc Pasquie 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 and Quality of Life Outcomes Quality of life Physical activity Paediatrics Inherited cardiac arrhythmia Genetic cardiomyopathy |
author_facet |
Pascal Amedro Oscar Werner Hamouda Abassi Aymeric Boisson Luc Souilla Sophie Guillaumont Johanna Calderon Anne Requirand Marie Vincenti Victor Pommier Stefan Matecki Gregoire De La Villeon Kathleen Lavastre Alain Lacampagne Marie-Christine Picot Constance Beyler Christophe Delclaux Yves Dulac Aitor Guitarte Philippe Charron Isabelle Denjoy-Urbain Vincent Probst Alban-Elouen Baruteau Philippe Chevalier Sylvie Di Filippo Jean-Benoit Thambo Damien Bonnet Jean-Luc Pasquie |
author_sort |
Pascal Amedro |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
Health and Quality of Life Outcomes |
issn |
1477-7525 |
publishDate |
2021-07-01 |
description |
Abstract Background Advances in paediatric cardiology have improved the prognosis of children with inherited cardiac disorders. However, health-related quality of life (QoL) and physical activity have been scarcely analysed in children with inherited cardiac arrhythmia or inherited cardiomyopathy. Moreover, current guidelines on the eligibility of young athletes with inherited cardiac disorders for sports participation mainly rely on expert opinions and remain controversial. Methods The QUALIMYORYTHM trial is a multicentre observational controlled study. The main objective is to compare the QoL of children aged 6 to 17 years old with inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or inherited cardiomyopathy (hypertrophic, dilated, or restrictive cardiomyopathy), to that of age and gender-matched healthy subjects. The secondary objective is to assess their QoL according to the disease’s clinical and genetic characteristics, the level of physical activity and motivation for sports, the exercise capacity, and the socio-demographic data. Participants will wear a fitness tracker (ActiGraph GT3X accelerometer) 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%. Discussion After focusing on the survival in children with inherited cardiac disorders, current research is expanding to patient-reported outcomes and secondary prevention. The QUALIMYORYTHM trial intends to improve the level of evidence for future guidelines on sports eligibility in this population. Trial registration ClinicalTrials.gov Identifier: NCT04712136, registered on January 15th, 2021 ( https://clinicaltrials.gov/ct2/show/NCT04712136 ). |
topic |
Quality of life Physical activity Paediatrics Inherited cardiac arrhythmia Genetic cardiomyopathy |
url |
https://doi.org/10.1186/s12955-021-01825-6 |
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doaj-d56b3be256d042baaf62bc952e6d1f502021-08-01T11:31:14ZengBMCHealth and Quality of Life Outcomes1477-75252021-07-011911910.1186/s12955-021-01825-6Health-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 methodsPascal Amedro0Oscar Werner1Hamouda Abassi2Aymeric Boisson3Luc Souilla4Sophie Guillaumont5Johanna Calderon6Anne Requirand7Marie Vincenti8Victor Pommier9Stefan Matecki10Gregoire De La Villeon11Kathleen Lavastre12Alain Lacampagne13Marie-Christine Picot14Constance Beyler15Christophe Delclaux16Yves Dulac17Aitor Guitarte18Philippe Charron19Isabelle Denjoy-Urbain20Vincent Probst21Alban-Elouen Baruteau22Philippe Chevalier23Sylvie Di Filippo24Jean-Benoit Thambo25Damien Bonnet26Jean-Luc Pasquie27Department of Paediatric and Adult Congenital Cardiology, M3C National Reference Centre, Haut-Lévêque Cardiology Hospital, Bordeaux University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPaediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University HospitalPhyMedExp, INSERM, CNRS, University of MontpellierEpidemiology and Clinical Research Department, Montpellier University HospitalPaediatric Cardiology and Physiology Department, Robert Debré University Hospital, University of Paris, AP-HPPaediatric Cardiology and Physiology Department, Robert Debré University Hospital, University of Paris, AP-HPPaediatric Cardiology Department, M3C Regional Reference Centre, Toulouse University HospitalPaediatric Cardiology Department, M3C Regional Reference Centre, Toulouse University HospitalDepartment of Cardiology, National Reference Centre for Inherited Cardiomyopathy, University of Paris, AP-HPDepartment of Cardiology, National Reference Centre for Inherited Cardiomyopathy, University of Paris, AP-HPDepartment of Cardiology, National Reference Centre for Inherited Cardiac Arrhythmia, L’institut du thorax, INSERM, CNRS, University of Nantes, Nantes University HospitalDepartment of Pediatric Cardiology and Pediatric Cardiac Surgery, L’Institut du Thorax, INSERM, CNRS, University of Nantes, Nantes University HospitalDepartment of Congenital Cardiology, National Reference Centre for Inherited Cardiac Arrhythmia, University of Lyon, Lyon University HospitalDepartment of Congenital Cardiology, National Reference Centre for Inherited Cardiac Arrhythmia, University of Lyon, Lyon University HospitalDepartment of Paediatric and Adult Congenital Cardiology, M3C National Reference Centre, Haut-Lévêque Cardiology Hospital, Bordeaux University HospitalPaediatric Cardiology Department, Necker-Enfants malades, M3C National Reference Centre, University of Paris, AP-HPCardiology Department of Cardiology, Regional Reference Centre for Inherited Cardiac Arrhythmia, Montpellier University HospitalAbstract Background Advances in paediatric cardiology have improved the prognosis of children with inherited cardiac disorders. However, health-related quality of life (QoL) and physical activity have been scarcely analysed in children with inherited cardiac arrhythmia or inherited cardiomyopathy. Moreover, current guidelines on the eligibility of young athletes with inherited cardiac disorders for sports participation mainly rely on expert opinions and remain controversial. Methods The QUALIMYORYTHM trial is a multicentre observational controlled study. The main objective is to compare the QoL of children aged 6 to 17 years old with inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or inherited cardiomyopathy (hypertrophic, dilated, or restrictive cardiomyopathy), to that of age and gender-matched healthy subjects. The secondary objective is to assess their QoL according to the disease’s clinical and genetic characteristics, the level of physical activity and motivation for sports, the exercise capacity, and the socio-demographic data. Participants will wear a fitness tracker (ActiGraph GT3X accelerometer) 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%. Discussion After focusing on the survival in children with inherited cardiac disorders, current research is expanding to patient-reported outcomes and secondary prevention. The QUALIMYORYTHM trial intends to improve the level of evidence for future guidelines on sports eligibility in this population. Trial registration ClinicalTrials.gov Identifier: NCT04712136, registered on January 15th, 2021 ( https://clinicaltrials.gov/ct2/show/NCT04712136 ).https://doi.org/10.1186/s12955-021-01825-6Quality of lifePhysical activityPaediatricsInherited cardiac arrhythmiaGenetic cardiomyopathy |