Clinical trial NCT05666986: Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Diaphragmatic Hernia
Keywords: CDH
physical activity and sports
childhood and adolescence
environment sociological
psychological clinical
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: APEHDia, a french CDH patient association
name: Rare Disease Foundation, France
First posted: 2022-12-28
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-questionnaire (for the subjects)
timeFrame: At the time of inclusion
measure: Self-questionnaire (for the subject's parents)
timeFrame: At the time of inclusion
measure: semi-directive interview of the subject
timeFrame: At the time of inclusion
measure: semi-directive interview of the subject's parents
timeFrame: At the time of inclusion
Secondary outcomes:
measure: study of the diaphragmatic kinetics by cardiac MRI
timeFrame: At the time of inclusion
measure: Self-questionnaire and interviews (for the subjects)
timeFrame: At the time of inclusion
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Sébastien MUR, MD
role: PRINCIPAL_INVESTIGATOR
References: