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)

NCT07191106 | Recruiting

• 1 other identifier: GHIRM_RIRCM20241122
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

IBD, crohn, ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (10)

• 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

  From baseline (Month 0) to Month 3

• Assess the feasibility of the Remote Adapted Physical Activity Program

  From baseline (Month 0) to Month 3

• Assess the feasibility of the of the Remote Adapted Physical Activity Program

  From baseline (Month 0) to Month 3

• impact of APA on psychological status

  From baseline (Month 0) to Month 3

• impact of APA on fatigue level

  From baseline (Month 0) to Month 3

Study Arms (1)

Pre- and post-intervention comparison following participation in the Adapted Physical Activity (APA)

EXPERIMENTAL

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

Interventions

adapted physical activity PROCEDURE

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

Pre- and post-intervention comparison following participation in the Adapted Physical Activity (APA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Raincy Montfermeil Hospital Group: lead
• Janssen Cilag S.A.S.: collaborator

Study Sites (2)

GHI Le Raincy Montfermeil

Montfermeil, 93370, France

RECRUITING

CHU Nantes

Nantes, 44093, France

NOT YET RECRUITING

Related Publications (4)

• 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.

  PMID: 21560190 BACKGROUND

• 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.

  PMID: 39478988 BACKGROUND

• 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.

  PMID: 27914657 BACKGROUND

• 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.

  PMID: 27914655 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Stephane NAHON, Professor

CONTACT

+33141708000; stephane.nahon@ght-gpne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: September 24, 2025
• Study Start: September 15, 2025
• Primary Completion: October 30, 2025
• Study Completion: March 31, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

FR (2)