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Recruiting NCT07305454

Impact of a Structured Therapeutic Education Session on the Practice of Adapted Physical Activity in Chronic Inflammatory Bowel Diseases

Observational Chronic Inflammatory Bowel Disease

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: Inflammatory Bowek Disk Questionnaires, Short-International Physical Activity Questionnaries.
Who it may be relevant to
Registry conditions: Chronic Inflammatory Bowel Disease. Basic parameters: 18 years — 100 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

Chronic inflammatory bowel diseases (IBD; including Crohn's disease and ulcerative colitis) significantly impact patients' quality of life. Among non-pharmacological therapies, adapted physical activity (APA) has demonstrated its beneficial impact, particularly on fatigue, anxiety, digestive symptoms, and the overall quality of life of patients with IBD. The real-world implementation of APA remains insufficient, primarily due to limited patient adherence to this prescription. Patient therapeutic education (PTE) represents a potentially powerful lever for promoting engagement in APA by addressing barriers related to a lack of awareness (fear of symptom worsening) and lack of motivation. No dedicated study has specifically evaluated the effect of targeted PTE sessions on adherence to physical activity in IBD. The objective of the present feasibility study will be to determine whether a single therapeutic education session focused on the digestive and systemic benefits of APA has an impact on the rate of physical activity practice in the medium term among patients with IBD in clinical remission for at least 3 months.

Interventions

  • Diagnostic test Inflammatory Bowek Disk Questionnaires
    Patients will be asked to complete the questionnaires regarding bowel inflammation at enrollment, 6 months later, and 12 months later.
  • Other Short-International Physical Activity Questionnaries
    Patients will be asked to complete the physical activity questionnaire 6 months later and 12 months later.

Primary outcome measures

  • Effectiveness of therapeutic education intervention on physical activity practice [Time frame: 12 months after the inclusion]
Secondary outcome measures (8)
  • study the impact on quality of life at 6 months [Time frame: 6 months after the inclusion]
  • Study the impact on quality of life in 12 months [Time frame: 12 months after the inclusion]
  • study the impact on fatigue reported at 6 months [Time frame: 6 months after the inclusion]
  • study the impact on fatigue reported at 12 months [Time frame: 12 months after the inclusion]
  • study the correlation between increased overall muscle strength and improved quality of life [Time frame: 12 months after the inclusion]
  • Study of the impact on the evolution of IBD activity at 6 months [Time frame: 6 months after the inclusion]
  • Study of the impact on the evolution of IBD activity at 12 months [Time frame: 12 months after the inclusion]
  • study the impact on the monitoring of the prescription of adapted physical activity [Time frame: 12 months after the inclusion]

Eligibility criteria

Inclusion criteria

  • Confirmed diagnosis of Inflammatory Bowel Disease
  • Crohn's disease in clinical remission (defined by a Harvey Bradshaw Index ≤ 5) or ulcerative colitis in clinical remission (defined by a Mayo score < 3 and no subscore > 1) for at least 3 months
  • Social Security coverage

Exclusion criteria

  • Pregnant or breastfeeding woman
  • Patient under legal guardianship
  • Cardiovascular or rheumatic conditions contraindicating participation in sports
  • Neurological conditions with residual deficits contraindicating participation in sports
  • Refusal or inability to consent to participation

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
Case-only

Study locations

France · 1 center
  • Service de Gastro-Entérologie, CHU Toulouse, Hôpital Rangueil, 1 avenue Jean Poulhès — Toulouse

Identifiers

NCT: NCT07305454 · RC31/25/0588 · ID-RCB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗