Pilot Feasibility and Impact Study of a Remote Adapted Physical Activity Program on the Quality of Life of Patients With Inflammatory Bowel Disease (IBD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: adapted physical activity (Procedure)
结局指标
主要结局
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
时间窗: From baseline (Month 0) to Month 3
Change in total Inflammatory Bowel Disease Questionnaire (IBDQ-32) score between baseline and the end of the program at Month 3 (M3)
次要结局
- 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)
- impact of APA on psychological status(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 fatigue level(From baseline (Month 0) to Month 3)
- Impact of APA on IBD activity_ crohn's disease(From baseline (Month 0) to Month 3)
- Impact of APA on IBD activity_ ulcerative colitis(From baseline (Month 0) to Month 3)
- evaluation of Persistence of physical activity(From baseline (Month 0) to Month 3)
- Change in Biological Markers of Disease Activity (CRP and Fecal Calprotectin)(From baseline (Month 0) to Month 3)
- Evaluation of satisfaction level assessed using a 5-point Likert scale.(month 3)