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Recruiting NCT07383844

Analysis of Barriers and Facilitators to Adapted Physical Activity for Pediatric Patients With Chronic Inflammatory Bowel Diseases

Observational Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IMPACT-III questionnaires, Data collection: CAPAS-Q, semi-structured interview.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis). Basic parameters: 10 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to identify perceived barriers and facilitators to regular physical activity among children and adolescents with inflammatory bowel disease (IBD) followed in pediatric gastroenterology. Approximately 60 participants aged 10-17 years will complete two self-administered questionnaires (CAPAS-Q for physical activity/sedentary behavior and IMPACT-III for health-related quality of life) and take part in a single semi-structured interview exploring experiences, obstacles, and levers to support sustainable physical activity. Relevant clinical data (disease characteristics, treatment and selected routine clinical parameters) will be extracted from the medical record. Participation is limited to one visit (about 45-60 minutes) during a routine hospital appointment, with no additional intervention or follow-up required.

Interventions

  • Other IMPACT-III questionnaires
    Participants complete the self-administered questionnaires IMPACT-III)
  • Other Data collection: CAPAS-Q
    Participants complete the self-administered questionnaires CAPAS-Q.
  • Other semi-structured interview
    participate in a semi-structured interview about perceived barriers and facilitators to physical activity. No counseling, training, or treatment is provided.

Primary outcome measures

  • Perceived barriers and facilitators to regular physical activity [Time frame: at the inclusion]
Secondary outcome measures (2)
  • Physical activity level and sedentary behavior (CAPAS-Q) [Time frame: at the inclusion]
  • Health-related quality of life (IMPACT-III) [Time frame: at the inclusion]

Eligibility criteria

Inclusion criteria

  • Aged 10 to 17 years at inclusion.
  • Diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis) confirmed and diagnosed for at least 6 months.
  • Followed in the pediatric gastroenterology department at Hôpital Lenval (CHU de Nice).
  • Sufficient cognitive and language abilities to understand questionnaires and participate in an individual interview.
  • Affiliated to, or beneficiary of, a social security scheme.
  • no parental objection to participation (non-opposition).

Exclusion criteria

  • Younger than 10 years or older than 17 years.
  • No IBD diagnosis, or IBD diagnosed less than 6 months ago.
  • Associated chronic condition (neurological, metabolic, psychiatric, or other) likely to interfere with questionnaire completion or interview participation.
  • Major language or cognitive impairment preventing adequate understanding or interview participation.
  • Not affiliated to, or not beneficiary of, a social security scheme.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 1 center
  • Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval — Nice

Identifiers

NCT: NCT07383844 · 25-HPNCL-08 Feels-MICI · 2025-A02019-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗