NCT04650009

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

November 24, 2020

Last Update Submit

May 19, 2022

Conditions

Keywords

Arrythmogenic right ventricular cardiomyopathyPhysical activityInherited cardiac diseasePeadiarics

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

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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

Long QT SyndromeBrugada SyndromePolymorphic Catecholaminergic Ventricular TachycardiaCardiomyopathy, HypertrophicCardiomyopathy, DilatedMotor Activity

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsGenetic Diseases, InbornTachycardia, VentricularTachycardiaCardiomyopathiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesCardiomegalyLaminopathiesBehavior

Study Officials

  • Pascal AMEDRO, MD-PhD

    UH MONTPELLIER

    STUDY DIRECTOR

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

Locations