Physical Activity in Children With Inherited Cardiac Diseases
1 other identifier
observational
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 24, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedMay 26, 2022
May 1, 2022
8 months
November 24, 2020
May 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Qualitative analysis evaluating the psychological and emotional impact of physical activity restriction on daily life.
1 day
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Presence of extra cardiac co-morbidity with motor or psychological repercussions hingering physical activity
- Refusal from children or parent to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uh Montpellier
Montpellier, 34295, France
Related 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.
PMID: 34756533BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pascal AMEDRO, MD-PhD
UH MONTPELLIER
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2020
First Posted
December 2, 2020
Study Start
May 1, 2020
Primary Completion
December 30, 2020
Study Completion
February 1, 2021
Last Updated
May 26, 2022
Record last verified: 2022-05