The Impact Of A Physician-led Exercise Programme On Quality Of Life, Muscle Mass And Clinical Response In Inflammatory Bowel Disease Patients During Induction With Medical Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The recruitment rates in both IBD arms.
研究概览
简要总结
The investigators propose the use of a 20 week physician-derived exercise programme will lead to an improvement in physical fitness which will in turn lead to an increase in muscle mass, a reduction in visceral obesity resulting in an improvement in biologic response, disease biomarkers (including a reduction in circulating pro-inflammatory cytokines), fatigue scores and quality of life.
详细描述
After completion, the investigators expect to describe the significant impact that exercise has on IBD disease control, response to biologics, modification of pro-inflammatory cytokine levels, quality of life and fatigue scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •18 years of age or above.
- •Confirmed moderate to severe inflammatory bowel disease based on endoscopic evaluation, clinical scoring tools and faecal calprotectin.
- •Be able to provide written informed consent.
- •Stable dose of steroids.
- •Physically able to complete an exercise programme.
- •Healthy controls.
排除标准
- •Inability to participate in the exercise program (unable to perform 6MWT, unable to attend for assessment of parameters at any time point).
- •An uncontrolled cardiovascular condition such as unstable angina, uncontrolled cardiac arrhythmias, uncontrolled symptomatic heart failure or symptomatic severe aortic stenosis.
- •A significant musculoskeletal condition, neurological condition, mental illness or intellectual disability that restricts participation in a physical exercise program.
- •Pregnancy.
- •Healthy controls with underlying inflammatory conditions.
研究组 & 干预措施
Inflammatory Bowel Disease Exercise Group
The exercise group will be randomized to a 20-week physician-prescribed exercise programme following the principles of Frequency, Intensity, Time, and Type (FITT) in addition to best medical therapy with the aim of increasing physical fitness levels, inflammatory response, quality of life/fatigue improvements and favorable body composition changes.
干预措施: Physician-prescribed Exercise Programme (Behavioral)
Inflammatory Bowel Disease Exercise Group
The exercise group will be randomized to a 20-week physician-prescribed exercise programme following the principles of Frequency, Intensity, Time, and Type (FITT) in addition to best medical therapy with the aim of increasing physical fitness levels, inflammatory response, quality of life/fatigue improvements and favorable body composition changes.
干预措施: Best Medical Therapy (Drug)
Inflammatory Bowel Disease Control Group
The IBD control group will be randomized to best medical therapy alone.
干预措施: Best Medical Therapy (Drug)
结局指标
主要结局
The recruitment rates in both IBD arms.
时间窗: 26 weeks
A calculation of the percentage of people approached who participate in the intervention (recruitment).
The retention rate in both IBD arms.
时间窗: 26 weeks
A calculation of the percentage of people approached who complete the intervention.
The adherence rate in both IBD arms.
时间窗: 26 weeks
A calculation of the percentage of people approached who adhered to the intervention.
次要结局
- Change in muscle mass measured by bioelectrical impedance analysis(26 weeks)
- Change in muscle mass measured by ultrasound(26 weeks)
- Change in visceral fat measured by bioelectrical impedance analysis(26 weeks)
- Change in fatigue score between the IBD groups in response to exercise(12 and 26 weeks)
- Inflammatory response between IBD groups measured using C-Reactive protein(12 and 26 weeks)
- Inflammatory response between IBD groups measured using pro-inflammatory cytokines(12 and 26 weeks)
- Clinical remission in response to exercise intervention(12 and 26 weeks)
- Change in Quality of Life in response to exercise(12 and 26 weeks)
- Change in handgrip strength(12 and 26 weeks)
- Change in endoscopic disease activity between IBD groups(26 weeks)
- Inflammatory response between IBD groups measured using faecal calprotectin(12 and 26 weeks)
- A change in physical fitness between the IBD patient arms(26 weeks)