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)

NCT ID: NCT07191106

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease (IBD) Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot, multicenter, before-and-after study designed to assess the feasibility and preliminary effectiveness of a remotely delivered Adapted Physical Activity (APA) intervention via a mobile application. This is a low-risk, minimal constraint interventional study involving human participants.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

adapted physical activity

Intervention Type PROCEDURE

Comparative before-and-after study over a 3-month period of remote Adapted Physical Activity (APA) delivered through the MOOV+ application

Interventions

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adapted physical activity

Comparative before-and-after study over a 3-month period of remote Adapted Physical Activity (APA) delivered through the MOOV+ application

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Cilag S.A.S.

INDUSTRY

Sponsor Role collaborator

Raincy Montfermeil Hospital Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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GHI Le Raincy Montfermeil

Montfermeil, , France

Site Status RECRUITING

CHU Nantes

Nantes, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Stephane NAHON, Professor

Role: CONTACT

+33141708000

Facility Contacts

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Stephane NAHON, Professor

Role: primary

0033141708000

Catherine LE BERRE, Doctor

Role: primary

0033.2.40.08.33.33

References

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Nahon S, Lahmek P, Saas C, Durance C, Olympie A, Lesgourgues B, Gendre JP. Socioeconomic and psychological factors associated with nonadherence to treatment in inflammatory bowel disease patients: results of the ISSEO survey. Inflamm Bowel Dis. 2011 Jun;17(6):1270-6. doi: 10.1002/ibd.21482. Epub 2010 Oct 25.

Reference Type BACKGROUND
PMID: 21560190 (View on PubMed)

Sarter H, Cretin T, Savoye G, Fumery M, Leroyer A, Dauchet L, Paupard T, Coevoet H, Wils P, Richard N, Turck D, Ley D, Gower-Rousseau C; EPIMAD study Group. Incidence, prevalence and clinical presentation of inflammatory bowel diseases in Northern France: a 30-year population-based study. Lancet Reg Health Eur. 2024 Oct 18;47:101097. doi: 10.1016/j.lanepe.2024.101097. eCollection 2024 Dec.

Reference Type BACKGROUND
PMID: 39478988 (View on PubMed)

Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1.

Reference Type BACKGROUND
PMID: 27914657 (View on PubMed)

Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1. Epub 2016 Dec 1.

Reference Type BACKGROUND
PMID: 27914655 (View on PubMed)

Other Identifiers

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GHIRM_RIRCM20241122

Identifier Type: -

Identifier Source: org_study_id

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