Physical Activity in Children With Inherited Cardiac Diseases

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

Physical Activity in Children With Inherited Cardiac Diseases : a Qualitative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650009
• Other study ID #: RECHMPL20_0118
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 1, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brugada Syndrome
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cardiomyopathy, Hypertrophic
• Catecholaminergic Polymorphic Ventricular Tachycardia
• Dilated Cardiomyopathy
• Heart Diseases
• Hypertrophic Cardiomyopathy
• Long QT Syndrome
• Syndrome
• Tachycardia
• Tachycardia, Ventricular

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Paediatric Cardiology and Rehabilitation Unit, St-Pierre Institute

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children with inheritec cardiac disorders respecting the current European guidelines on sports cardiology and exercise (ESC 2020).	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).	1 day
Secondary	Qualitative analysis evaluating the psychological and emotional impact of physical activity restriction on daily life.	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.	1 day