Chronic Inflammatory Bowel DiseaseETAP-MICINCT07305454
Impact of a Structured Therapeutic Education Session on the Practice of Adapted Physical Activity in Chronic Inflammatory Bowel Diseases
An observational study of Chronic Inflammatory Bowel Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Inflammatory Bowel Disease
- What is being tested?
- Inflammatory Bowek Disk Questionnaires and Short-International Physical Activity Questionnaries
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2026to 10 Feb 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic inflammatory bowel disease in clinical remission (Crohn's disease or ulcerative colitis)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Gastro-Entérologie, CHU Toulouse, Hôpital Rangueil, 1 avenue Jean Poulhès
Toulouse, 31059
Emeline Muller, 05 61 77 87 07 ext. +33, muller.e@chu-toulouse.Fr
About this study
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.
Read more
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.
- Conditions
- Chronic Inflammatory Bowel Disease
- Being tested
- Inflammatory Bowek Disk Questionnaires, Short-International Physical Activity Questionnaries
- Keywords
- crohn disease, ulcerative colitis, physical activity
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory Bowek Disk QuestionnairesDiagnostic test
Patients will be asked to complete the questionnaires regarding bowel inflammation at enrollment, 6 months later, and 12 months later.
Short-International Physical Activity QuestionnariesOther
Patients will be asked to complete the physical activity questionnaire 6 months later and 12 months later.
| Study group | Role | What they receive |
|---|---|---|
| patients with chronic inflammatory bowel disease | patients with chronic inflammatory bowel disease in clinical remission Receives: Diagnostic Test: Inflammatory Bowek Disk Questionnaires; Other: Short-International Physical Activity Questionnaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of therapeutic education intervention on physical activity practice
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.
Measured: 12 months after the inclusion
Secondary outcomes (8)
study the impact on quality of life at 6 months
measure of quality of life with the IBD disk questionnaires answers at 6 months
Measured: 6 months after the inclusion
Study the impact on quality of life in 12 months
measure of quality of life with the IBD disk questionnaires answers at 12 months
Measured: 12 months after the inclusion
study the impact on fatigue reported at 6 months
Measure of fatigue reported according to one of the items of the IBD Disk questionnaire at 6 months
Measured: 6 months after the inclusion
study the impact on fatigue reported at 12 months
Measure of fatigue reported according to one of the items of the IBD Disk questionnaire at 12 months
Measured: 12 months after the inclusion
study the correlation between increased overall muscle strength and improved quality of life
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
Measured: 12 months after the inclusion
Study of the impact on the evolution of IBD activity at 6 months
measurement of clinical activity in chronic inflammatory bowel disease at 6 months
Measured: 6 months after the inclusion
Study of the impact on the evolution of IBD activity at 12 months
measurement of clinical activity in chronic inflammatory bowel disease at 12 months
Measured: 12 months after the inclusion
study the impact on the monitoring of the prescription of adapted physical activity
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.
Measured: 12 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start10 Feb 2026
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 71 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305454
- Sponsor's protocol ID
- RC31/25/0588
- Other IDs
- ID-RCB
- Acronym
- ETAP-MICI
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Structured Therapeutic Education Session on the Practice of Adapted Physical Activity in Chronic Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT07305454
- Acronym / sponsor ID
- ETAP-MICI / RC31/25/0588
- Conditions
- Chronic Inflammatory Bowel Disease
- Keywords
- crohn disease, ulcerative colitis, physical activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Feb 2029 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with chronic inflammatory bowel disease | – | Diagnostic Test: Inflammatory Bowek Disk Questionnaires, Other: Short-International Physical Activity Questionnariespatients with chronic inflammatory bowel disease in clinical remission |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic inflammatory bowel disease in clinical remission (Crohn's disease or ulcerative colitis)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflammatory Bowek Disk QuestionnairesPatients will be asked to complete the questionnaires regarding bowel inflammation at enrollment, 6 months later, and 12 months later. | Diagnostic test | patients with chronic inflammatory bowel disease |
| Short-International Physical Activity QuestionnariesPatients will be asked to complete the physical activity questionnaire 6 months later and 12 months later. | Other | patients with chronic inflammatory bowel disease |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Bowel Disease, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyrielle GILLETTA, MD (05 61 31 22 31 ext. +33, gilletta.c@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of therapeutic education intervention on physical activity practice (time frame: 12 months after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.