Sponsor study identifier
observational
28
1 country
1
Study Start
May 1, 2020
Actual (reported)Primary Completion
December 30, 2020
Actual (reported)Study Completion
February 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2020
Actual (reported)November 24, 2020
Actual (reported)December 2, 2020
Actual (reported)December 30, 2020
Actual (reported)February 1, 2021
Actual (reported)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
Qualitative analysis evaluating the psychological and emotional impact of physical activity restriction on daily life.
1 day
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
Uh Montpellier
Montpellier, 34295, France
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.
Pascal AMEDRO, MD-PhD
UH MONTPELLIER
28 participants (actual enrollment reported by the registry).
First Submitted
November 24, 2020
First Posted
December 2, 2020
Study Start
May 1, 2020
Actual (reported)Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
Contact the study team to confirm eligibility.
Primary Completion
December 30, 2020
Actual (reported)Study Completion
February 1, 2021
Actual (reported)Last Updated
May 26, 2022
Record last verified: 2022-05
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