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NCT Number: NCT07305454

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

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.

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Key information

Conditions

Chronic Inflammatory Bowel Disease Behavior Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Motor Activity

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Gastro-Entérologie, CHU Toulouse, Hôpital Rangueil, 1 avenue Jean Poulhès

Toulouse, 31059, France

Location status: Recruiting

Location contact

Emeline Muller

CONTACT

[email protected]

05 61 77 87 07 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inflammatory Bowek Disk Questionnaires

Diagnostic 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 Questionnaries

Other

Patients will be asked to complete the physical activity questionnaire 6 months later and 12 months later.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cyrielle GILLETTA, MD

CONTACT

[email protected]

05 61 31 22 31 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: ETAP-MICI

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Dec 26, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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