Physical Activity in Children With Inherited Cardiac Diseases

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04650009
Collaborator
Paediatric Cardiology and Rehabilitation Unit, St-Pierre Institute (Other)
28
1
9.1
3.1

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
28 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Physical Activity in Children With Inherited Cardiac Diseases : a Qualitative
Actual Study Start Date :
May 1, 2020
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Feb 1, 2021

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uh Montpellier Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier
  • Paediatric Cardiology and Rehabilitation Unit, St-Pierre Institute

Investigators

  • Study Director: Pascal AMEDRO, MD-PhD, UH MONTPELLIER

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04650009
Other Study ID Numbers:
  • RECHMPL20_0118
First Posted:
Dec 2, 2020
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022