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Completed

NCT Number: NCT04650009

Physical Activity in Children With Inherited Cardiac Diseases

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.

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Key information

Conditions

Long QT Syndrome Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Arrhythmias, Cardiac Behavior Brugada Syndrome Cardiac Conduction System Disease Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiovascular Abnormalities Cardiovascular Diseases Catecholaminergic Polymorphic Ventricular Tachycardia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dilated Cardiomyopathy Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Heart Valve Diseases Hypertrophic Cardiomyopathy Laminopathies Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Polymorphic Catecholaminergic Ventricular Tachycardia Tachycardia Tachycardia, Ventricular

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of children with inheritec cardiac disorders respecting the current European guidelines on sports cardiology and exercise (ESC 2020).

    Time frame: 1 day

    Patient's physical activity will be analysed to evaluate the adherence to current European guidelines regarding physical activity. Patients will be categorized into 3 groups, upon the level of adherence to the guidelines (complete adherence, partial adherence et no adherence).

Secondary outcomes

  1. Qualitative analysis evaluating the psychological and emotional impact of physical activity restriction on daily life.

    Time frame: 1 day

    Patients will be interviewed by the principal investigator for 20 to 30 minutes with a focus on physical activity, in order to collect motivations, feelings and discourse of the patient, classified in main themes (positive, negative or neutral).

    No score is used in this study:

    The secondary outcome is a qualitative analysis.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Paediatric Cardiology and Rehabilitation Unit, St-Pierre Institute

Registry information

Official study title

Physical Activity in Children With Inherited Cardiac Diseases : a Qualitative

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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