Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia

NCT05666986 | Recruiting

• 2 other identifiers: 2021_03422021-A02518-33
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Diaphragmatic Hernia

Keywords

CDH; physical activity and sports; childhood and adolescence; environment sociological; psychological clinical

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• study of the diaphragmatic kinetics by cardiac MRI

  At the time of inclusion

• Self-questionnaire and interviews (for the subjects)

  At the time of inclusion

Study Arms (1)

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

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead
• APEHDia, a french CDH patient association: collaborator
• Rare Disease Foundation, France: collaborator

Study Sites (1)

chu de Lille

Lille, France

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Motor Activity

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Sébastien MUR, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien MUR, MD

CONTACT

0320445962; sebastien.mur@chu-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 28, 2022
• Study Start: May 19, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

FR (1)