Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia

Congenital Diaphragmatic Hernia Clinical Trial

— CHASAM  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666986
• Other study ID #: 2021_0342
• Secondary ID: 2021-A02518-33
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: March 2024

Study information

• Verified date: December 2022
• Source: University Hospital, Lille
• Contact: Sébastien MUR, MD
• Phone: 0320445962
• Email: sebastien.mur[@]chu-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	APEHDia, a french CDH patient association, Rare Disease Foundation, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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