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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: adapted physical activity.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Disease (IBD), Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Feasibility and Impact Study of a Remote Adapted Physical Activity Program on the Quality of Life of Patients With Inflammatory Bowel Disease (IBD)
Overview
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.
Interventions
- 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
Primary outcome measures
- 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]
Secondary outcome measures (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 [Time frame: 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]
- Assess the feasibility of the of the Remote Adapted Physical Activity Program [Time frame: From baseline (Month 0) to Month 3]
- impact of APA on psychological status [Time frame: From baseline (Month 0) to Month 3]
- impact of APA on fatigue level [Time frame: 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]
- Impact of APA on IBD activity_ ulcerative colitis [Time frame: From baseline (Month 0) to Month 3]
- evaluation of Persistence of physical activity [Time frame: 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]
- Evaluation of satisfaction level assessed using a 5-point Likert scale. [Time frame: month 3]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 2 centers
- GHI Le Raincy Montfermeil — Montfermeil
- CHU Nantes — Nantes
Publications
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07191106 · GHIRM_RIRCM20241122