NCT07305454

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
34mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026Feb 2029

First Submitted

Initial submission to the registry

December 12, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2029

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

December 12, 2025

Last Update Submit

February 10, 2026

Conditions

Keywords

crohn diseaseulcerative colitisphysical activity

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months after the inclusion

Secondary Outcomes (8)

  • study the impact on quality of life at 6 months

    6 months after the inclusion

  • Study the impact on quality of life in 12 months

    12 months after the inclusion

  • study the impact on fatigue reported at 6 months

    6 months after the inclusion

  • study the impact on fatigue reported at 12 months

    12 months after the inclusion

  • study the correlation between increased overall muscle strength and improved quality of life

    12 months after the inclusion

  • +3 more secondary outcomes

Study Arms (1)

patients with chronic inflammatory bowel disease

patients with chronic inflammatory bowel disease in clinical remission

Diagnostic Test: Inflammatory Bowek Disk QuestionnairesOther: Short-International Physical Activity Questionnaries

Interventions

Patients will be asked to complete the questionnaires regarding bowel inflammation at enrollment, 6 months later, and 12 months later.

patients with chronic inflammatory bowel disease

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

patients with chronic inflammatory bowel disease

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic inflammatory bowel disease in clinical remission (Crohn's disease or ulcerative colitis)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeMotor Activity

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesBehavior

Central Study Contacts

Cyrielle GILLETTA, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 26, 2025

Study Start

February 10, 2026

Primary Completion (Estimated)

August 10, 2027

Study Completion (Estimated)

February 10, 2029

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations