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)

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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 [Срок оценки: From baseline (Month 0) to Month 3]

Вторичные конечные точки (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 [Срок оценки: From baseline (Month 0) to Month 3]
• Assess the feasibility of the Remote Adapted Physical Activity Program [Срок оценки: From baseline (Month 0) to Month 3]
• Assess the feasibility of the of the Remote Adapted Physical Activity Program [Срок оценки: From baseline (Month 0) to Month 3]
• impact of APA on psychological status [Срок оценки: From baseline (Month 0) to Month 3]
• impact of APA on fatigue level [Срок оценки: From baseline (Month 0) to Month 3]
• Impact of APA on IBD activity_ crohn's disease [Срок оценки: From baseline (Month 0) to Month 3]
• Impact of APA on IBD activity_ ulcerative colitis [Срок оценки: From baseline (Month 0) to Month 3]
• evaluation of Persistence of physical activity [Срок оценки: From baseline (Month 0) to Month 3]
• Change in Biological Markers of Disease Activity (CRP and Fecal Calprotectin) [Срок оценки: From baseline (Month 0) to Month 3]
• Evaluation of satisfaction level assessed using a 5-point Likert scale. [Срок оценки: month 3]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 2 центра

• GHI Le Raincy Montfermeil — Montfermeil
• CHU Nantes — Nantes

Публикации

• 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

Идентификаторы

NCT: NCT07191106 · GHIRM_RIRCM20241122

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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