Clinical trial NCT04650009: Physical Activity in Children With Inherited Cardiac Diseases
Official title: Physical Activity in Children With Inherited Cardiac Diseases : a Qualitative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long QT Syndrome
Brugada Syndrome
Catecholaminergic Polymorphic Ventricular Tachycardia
Hypertrophic Cardiomyopathy
Dilated Cardiomyopathy
Keywords: Arrythmogenic right ventricular cardiomyopathy
Physical activity
Inherited cardiac disease
Peadiarics
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Paediatric Cardiology and Rehabilitation Unit, St-Pierre Institute
First posted: 2020-12-02
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will take place in two paediatric tertiaty hospitals : the paediatric and congenital cardiology department of Montpellier university hospital and the paediatric cardiology and rehabilitation unit of St-Pierre institute in Palavas-Les-Flots, France.

Children aged from 6 to 18 years old with genetic and/or clinical diagnosis of inherited cardiomyopathies (hypertrophic cardiomyopathy, dilated cardiomyopathy and arrythmogenic right ventricular cardiomyopathy) or inherited primary arrhythmia syndrome (long QT syndrome, brugada syndrome and catecholaminergic polymorphic ventricular tachycardia) are eligible to participate in this study. Each subject accepting to participate during the annual follow up consultation will be enrolled

Brief summary: Use lay language.

Current guidelines regarding physical activity in patients with inherited arrhythmia and cardiomyopathy are mostly dedicated to adult patients, with a special focus on sports competition. Their application to the pediatric population has been scarcely evaluated.

Physical activity is well known for its health benefits but may be dangerous in this population, which leads to confusion within the medical community and among patients. Actual physical activity of children with such inherited cardiac disorders is unknown.

This study aimed to assess the level of physical activity in children with inherited arrhythmia and cardiomyopathy, and the adherence to the current European guidelines on the subject. Secondary objectives aimed to assess through a qualitative analysis the impact of the disease on physical activity and daily life in this population.

The level of physical activity and adherence to current guidelines will be determined from interviews between the patient and the principal investigator. Each patient will be questioned in order to explore the experiences, motivations and feelings of participants regarding physical activity. The standardized questionnaire was created by the principal investigator and members of the clinical research team.

The investigators believe that many children practice physical activity outside the current guidelines and hope to identify the main determinants of physical activity in this population.


Eligibility criteria: Inclusion criteria:

Children from 6 to 18 years old with clinical and/or genetic diagnosis of :

* Long QT syndrome
* Brugada syndrome
* Catecholaminergic polymorphic ventricular tachycardia
* Hypertrophic cardiomyopathy
* Dilated cardiomyopathy
* Arrythmogenic right ventricular cardiomyopathy

Exclusion criteria:

* Presence of extra cardiac co-morbidity with motor or psychological repercussions hingering physical activity
* Refusal from children or parent to participate in the study

Primary outcomes:
measure: Proportion of children with inheritec cardiac disorders respecting the current European guidelines on sports cardiology and exercise (ESC 2020).
timeFrame: 1 day
Secondary outcomes:
measure: Qualitative analysis evaluating the psychological and emotional impact of physical activity restriction on daily life.
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Pascal AMEDRO, MD-PhD
role: STUDY_DIRECTOR
References:
citation: Boisson A, De La Villeon G, Huguet H, Abassi H, Pasquie JL, Lavastre K, Matecki S, Guillaumont S, Requirand A, Calderon J, Amedro P. Physical activity and aerobic fitness in children with inherited cardiac diseases. Arch Cardiovasc Dis. 2021 Nov;114(11):727-736. doi: 10.1016/j.acvd.2021.07.004. Epub 2021 Oct 27.