- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07305454
Impact of a Structured Therapeutic Education Session on the Practice of Adapted Physical Activity in Chronic Inflammatory Bowel Diseases (ETAP-MICI)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Cyrielle GILLETTA, MD
- Phone Number: +33 05 61 31 22 31
- Email: gilletta.c@chu-toulouse.fr
Study Locations
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-
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Toulouse, France, 31059
- Recruiting
- Service de Gastro-Entérologie, CHU Toulouse, Hôpital Rangueil, 1 avenue Jean Poulhès
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Contact:
- Emeline Muller
- Phone Number: +33 05 61 77 87 07
- Email: muller.E@chu-toulouse.Fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients with chronic inflammatory bowel disease
patients with chronic inflammatory bowel disease in clinical remission
|
Patients will be asked to complete the questionnaires regarding bowel inflammation at enrollment, 6 months later, and 12 months later.
Patients will be asked to complete the physical activity questionnaire 6 months later and 12 months later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of therapeutic education intervention on physical activity practice
Time Frame: 12 months after the inclusion
|
Measure the amount of metabolic equivalent or MET/Week (Metabolic Equivalent Task) at 12 months, based on the short-IPAQ questionnaire assessing physical activities reported by the patient over the last 7 days.
|
12 months after the inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
study the impact on quality of life at 6 months
Time Frame: 6 months after the inclusion
|
measure of quality of life with the IBD disk questionnaires answers at 6 months
|
6 months after the inclusion
|
|
Study the impact on quality of life in 12 months
Time Frame: 12 months after the inclusion
|
measure of quality of life with the IBD disk questionnaires answers at 12 months
|
12 months after the inclusion
|
|
study the impact on fatigue reported at 6 months
Time Frame: 6 months after the inclusion
|
Measure of fatigue reported according to one of the items of the IBD Disk questionnaire at 6 months
|
6 months after the inclusion
|
|
study the impact on fatigue reported at 12 months
Time Frame: 12 months after the inclusion
|
Measure of fatigue reported according to one of the items of the IBD Disk questionnaire at 12 months
|
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
|
Measurement of estimated muscle strength using a hand grip test before and after intervention as part of annual malnutrition screening and response to the quality of life questionnaire
|
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
|
measurement of clinical activity in chronic inflammatory bowel disease at 6 months
|
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
|
measurement of clinical activity in chronic inflammatory bowel disease at 12 months
|
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
|
Monitoring of the APA prescription estimated according to the proportion of patients who completed at least 12 APA sessions (i.e. 1 weekly session for 3 months) and the average number of APA sessions completed.
|
12 months after the inclusion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/25/0588
- ID-RCB (Other Identifier: 2023-A01756-39)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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