CHASAM: Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05666986

Collaborator

APEHDia, a french CDH patient association (Other), Rare Disease Foundation, France (Other)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Diaphragmatic Hernia

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

study of the diaphragmatic kinetics by cardiac MRI [At the time of inclusion]
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.
Self-questionnaire and interviews (for the subjects) [At the time of inclusion]
Analysis of the verbatim of the self-questionnaires and the interviews, with regard to the real physical capacities of the subjects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.