Pilot Study Assessing the Feasibility and Impact of a Remote Adapted Physical Activity Program on Quality of Life in Patients With Inflammatory Bowel Disease (IBD) (APIMICI)

September 22, 2025 updated by: Raincy Montfermeil Hospital Group

Pilot Feasibility and Impact Study of a Remote Adapted Physical Activity Program on the Quality of Life of Patients With Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Disease (IBD) is a chronic relapsing condition that affects the gastrointestinal tract and is increasingly diagnosed in adolescents and young adults. Although anti-TNFα therapies are effective in reducing disease activity and improving quality of life, they are frequently associated with side effects such as fatigue, weight gain, and joint pain, which may be mitigated by regular physical activity.

Emerging evidence suggests that light to moderate physical activity may help reduce systemic and intestinal inflammation and improve IBD-related outcomes. However, access to structured physical activity programs remains limited, and personal or professional constraints may hinder participation.

This pilot study aims to assess the feasibility and impact of a remotely delivered Adapted Physical Activity (APA) program on the quality of life of patients with Inflammatory Bowel Disease (IBD), including Crohn's disease and ulcerative colitis. This study evaluates the effects of a 12-weeks remote APA intervention on quality of life as the primary outcome.

Secondary objectives include assessing changes in anxiety and depression, fatigue levels, IBD activity, and smoking behavior. The findings from this study may inform the development of scalable, non-pharmacological strategies to support symptom management and well-being in individuals with IBD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Montfermeil, France, 93370
        • Recruiting
        • GHI Le Raincy Montfermeil
        • Contact:
      • Nantes, France, 44093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years and older
  • Diagnosis of Inflammatory Bowel Disease (IBD) established for at least 6 months
  • Patient is motivated to participate in the Adapted Physical Activity (APA) program
  • Medical certificate confirming fitness to engage in remote physical activity
  • Access to a digital device with internet connectivity enabling use of the MOOV+ application at home
  • Written informed consent freely given after appropriate information
  • Affiliation with, or beneficiary of, a national health insurance system

Exclusion Criteria:

  • Patients under 18 years of age
  • Medical contraindication to physical activity

  • High levels of physical activity as defined by the International Physical Activity Questionnaire (IPAQ):

    • Total >1500 MET-min/week of vigorous activity on at least 3 days, OR
    • Total physical activity >3000 MET-min/week, regardless of distribution
  • Presence of psychological disorders that may interfere with study participation
  • Lack of access to a device or internet connection enabling remote participation
  • Pregnant or breastfeeding women
  • Patients under legal guardianship or curatorship
  • Patients under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre- and post-intervention comparison following participation in the Adapted Physical Activity (APA)
There is no comparator group at this stage of the research. Patient data will be compared before and after participation in the Adapted Physical Activity (APA) program.
Procedure: adapted physical activity
Comparative before-and-after study over a 3-month period of remote Adapted Physical Activity (APA) delivered through the MOOV+ application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of a Remote Adapted Physical Activity Program Delivered via the MOOV+ Application on Quality of Life in Patients With Inflammatory Bowel Disease: A Pilot Before-and-After Study
Time Frame: From baseline (Month 0) to Month 3
Change in total Inflammatory Bowel Disease Questionnaire (IBDQ-32) score between baseline and the end of the program at Month 3 (M3)
From baseline (Month 0) to Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate the effect of the program on the different subdomains of health-related quality of life, including bowel symptoms, systemic symptoms, emotional function, and social function
Time Frame: From baseline (Month 0) to Month 3
Variation in the four IBDQ-32 subscale scores between baseline (Month 0) and the end of the program (Month 3)
From baseline (Month 0) to Month 3
Assess the feasibility of the Remote Adapted Physical Activity Program
Time Frame: From baseline (Month 0) to Month 3
Variation of participation rate (number of enrolled patients / number of eligible patients)
From baseline (Month 0) to Month 3
Assess the feasibility of the of the Remote Adapted Physical Activity Program
Time Frame: From baseline (Month 0) to Month 3
Adherence to the program measured by session attendance rate (sessions attended / sessions scheduled) and dropout rate (number and reasons for early withdrawal).
From baseline (Month 0) to Month 3
impact of APA on psychological status
Time Frame: From baseline (Month 0) to Month 3
HADS score
From baseline (Month 0) to Month 3
impact of APA on fatigue level
Time Frame: From baseline (Month 0) to Month 3
FACIT fatigue score
From baseline (Month 0) to Month 3
Impact of APA on IBD activity_ crohn's disease
Time Frame: From baseline (Month 0) to Month 3
variation of Harvey-Bradshaw Index (HBI)
From baseline (Month 0) to Month 3
Impact of APA on IBD activity_ ulcerative colitis
Time Frame: From baseline (Month 0) to Month 3
variation of partial mayo score
From baseline (Month 0) to Month 3
evaluation of Persistence of physical activity
Time Frame: From baseline (Month 0) to Month 3
International Physical Activity Questionnaire (IPAQ )
From baseline (Month 0) to Month 3
Change in Biological Markers of Disease Activity (CRP and Fecal Calprotectin)
Time Frame: From baseline (Month 0) to Month 3
The impact of Adapted Physical Activity (APA) on biological disease activity will be assessed through changes in C-reactive protein (CRP) levels and fecal calprotectin concentrations
From baseline (Month 0) to Month 3
Evaluation of satisfaction level assessed using a 5-point Likert scale.
Time Frame: month 3
Evaluation of Satisfaction with a Remote Adapted Physical Activity Program Delivered via MOOV+ (from "1:Very dissatisfied" to "5 : very satisfied")
month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Raincy Montfermeil Hospital Group

Collaborators

Janssen Cilag S.A.S.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

July 21, 2025

First Submitted That Met QC Criteria

September 22, 2025

First Posted (Estimated)

September 24, 2025

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHIRM_RIRCM20241122

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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