Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Janssen Cilag S.A.S. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 | 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 |
| 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 | 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 |
Not provided
Inclusion Criteria:
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):
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephane NAHON, Professor | Contact | +33141708000 | stephane.nahon@ght-gpne.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHI Le Raincy Montfermeil | Recruiting | Montfermeil | 93370 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21560190 | Result | 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. | |
| 39478988 | Result |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Assess the feasibility of the Remote Adapted Physical Activity Program |
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 | 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 | HADS score | From baseline (Month 0) to Month 3 |
| impact of APA on fatigue level | FACIT fatigue score | From baseline (Month 0) to Month 3 |
| Impact of APA on IBD activity_ crohn's disease | variation of Harvey-Bradshaw Index (HBI) | From baseline (Month 0) to Month 3 |
| Impact of APA on IBD activity_ ulcerative colitis | variation of partial mayo score | From baseline (Month 0) to Month 3 |
| evaluation of Persistence of physical activity | International Physical Activity Questionnaire (IPAQ ) | From baseline (Month 0) to Month 3 |
| Change in Biological Markers of Disease Activity (CRP and Fecal Calprotectin) | 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. | Evaluation of Satisfaction with a Remote Adapted Physical Activity Program Delivered via MOOV+ (from "1:Very dissatisfied" to "5 : very satisfied") | month 3 |
| CHU Nantes | Not yet recruiting | Nantes | 44093 | France |
|
| 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. |
| 27914657 | Result | 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. |
| 27914655 | Result | 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. |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
Not provided
Not provided