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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2021

01-12-2021 | Cardiomyopathy | Study protocol

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

Authors: 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

Published in: Health and Quality of Life Outcomes | Issue 1/2021

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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).
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Metadata
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
Authors
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
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2021
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-021-01825-6

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