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NCT Number: NCT05666986

Engagement in Physical Activities and Sports in Adolescents With 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.

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Key information

Conditions

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

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Self-questionnaire (for the subjects)

    Time frame: 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)

  2. Self-questionnaire (for the subject's parents)

    Time frame: At the time of inclusion

    to collect the subject's level of involvement in their sport (from the subject's parents' point of view

  3. semi-directive interview of the subject

    Time frame: 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)

  4. semi-directive interview of the subject's parents

    Time frame: 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 outcomes

  1. study of the diaphragmatic kinetics by cardiac MRI

    Time frame: 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.

  2. Self-questionnaire and interviews (for the subjects)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sébastien MUR, MD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • APEHDia, a french CDH patient association
  • Rare Disease Foundation, France

Registry information

Official study 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

Acronym: CHASAM

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 28, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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