Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia (CHASAM)

Identification of Obstacles and Facilitators to the Engagement in Physical and Sports Activities in a Population of Adolescents Operated on for a Diaphragmatic Hernia

The objective is to understand how a population of adolescents - who have undergone diaphragm surgery within their first month of life (i.e. subjects who have been carriers of a rare impacting disease such as congenital diaphragmatic hernia (CDH)) - engages in physical and sports activities and what can be the hindering factors as well as the factors facilitating these practices.

Based on self-questionnaires and semi-structured interviews, this research is a qualitative research in the field of human and social sciences.

The qualitative survey will make it possible to report on the experience of the disease of children and parents; in parallel, a complete medical evaluation of the subjects (clinical and para-clinical) will be carried out.

The analysis of the verbatim of the self-questionnaires and interviews with regard to the real physical capacities of the subjects, will be discussed.

Study Overview

• Status: Recruiting
• Conditions: Congenital Diaphragmatic Hernia

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Sébastien MUR, MD; Phone Number: +33 0320445962; Email: sebastien.mur@chu-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • CHU de Lille
    • Contact: Sébastien MUR; Phone Number: 0033320445962; Email: sebastien.mur@chu-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All adolescents who had CDH surgery in the first month of life, without any other pathology, now aged 12-18 and followed up at the CDH Lille Reference Center, will be asked to take part in the study.

Description

Inclusion Criteria:

• Child/adolescent having undergone surgery for CDH in the first month of life, aged 12 to 18 years; absence of polypathology (i.e. diaphragmatic hernia not associated with another pathology); follow-up at the CDH reference centre, Lille site
• Written consent from both parents allowing the collection of data from the child/adolescent
• Written consent from the parent(s) agreeing to participate in the study by answering the questionnaires and the individual interview, for themselves and for their child
• Possibility of accessing equipment to conduct a video-conference interview if necessary.

Exclusion Criteria:

• Parents or child/adolescent not understanding French
• Parents under guardianship or child under legal protection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adolescents who had CDH surgery in the first month of life,; without any other pathology, now aged 12-18 and followed up at the CDH Lille Reference Center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-questionnaire (for the subjects)	to collect the level of investment of the subject in their sport participation (from the subject's point of view)	At the time of inclusion
Self-questionnaire (for the subject's parents)	to collect the subject's level of involvement in their sport (from the subject's parents' point of view	At the time of inclusion
semi-directive interview of the subject	allowing the identification of the dynamics of involvement in physical activities and sports practices, from the point of view of the subject (the adolescent)	At the time of inclusion
semi-directive interview of the subject's parents	allowing the identification of the dynamics of involvement in physical activities and sports practices, from the point of view of the subject's parents	At the time of inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
study of the diaphragmatic kinetics by cardiac MRI	Complete clinical examination of the subjects and detailed paraclinical evaluation according to the recommendations of the PNDS with the addition of a sequence during the cardiac MRI allowing the study of the diaphragmatic kinetics.	At the time of inclusion
Self-questionnaire and interviews (for the subjects)	Analysis of the verbatim of the self-questionnaires and the interviews, with regard to the real physical capacities of the subjects.	At the time of inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: APEHDia, a french CDH patient association; Rare Disease Foundation, France
• Investigators: Principal Investigator: Sébastien MUR, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: childhood and adolescence; CDH; physical activity and sports; environment sociological; psychological clinical
• Additional Relevant MeSH Terms: Internal Hernia; Pathological Conditions, Anatomical; Congenital Abnormalities; Hernia; Hernia, Diaphragmatic; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Behavior; Hernias, Diaphragmatic, Congenital; Motor Activity
• Other Study ID Numbers: 2021_0342; 2021-A02518-33 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No