Vibration Exercise for Crohn's to Observe Response
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Inflammatory Bowel Disease Questionnaire (IBDQ)
研究概览
简要总结
Background: Crohn's disease (CD) is a long-term inflammatory condition of the digestive system. People with CD often have unpredictable and debilitating symptoms, including abdominal pain, diarrhoea and fatigue. In addition, they require long-term treatment with frequent negative effects and often need surgery and hospitalisations. Therefore, people with CD report a lower health-related quality of life (HRQOL) compared with other people. Doctors are constantly trying to find new treatments to improve HRQOL and control symptoms and whole body vibration exercise could be a potential treatment.
Exercise might be a simple, safe, and low-cost intervention for improving HRQOL in people with CD. This is because it has the potential to improve several aspects of physical, mental and social well-being simultaneously. Adults with CD have been shown to be less active than the general population and do not meet the recommended daily physical activity guidelines. One barrier to exercise is lack of time, however whole-body vibration exercise (where you stand and squat on a vibrating plate) can be done over a much shorter duration and at a lower intensity to gain potentially similar or at times greater benefits. More research is needed to understand the effects, both positive and negative of vibration exercise in people with CD.
Aim: This study begins to understand whether undertaking a supervised 6-week vibration exercise programme for adults with mild to moderately active Crohn's disease improves HRQoL and other symptoms such as fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 18-65 years old
- •Clinical diagnosis of CD for at least 4 weeks before randomization
- •Mild to moderate active CD (150-220 CDAI)
- •Stable medication for at least 4 weeks before randomization
- •Able to provide written consent, complete the study questionnaires and travel to the research centre for study assessment visits and exercise sessions
- •Be doing less than 60 minutes of purposeful exercise per week
排除标准
- •Over 65 years old Severe or uncontrolled medical conditions that make it undesirable for the patient to participate
- •Coexistent serious autoimmune disease such as rheumatoid arthritis or systemic sclerosis
- •Planned major surgery within the first 3 months after randomization
- •Are pregnant, or are planning pregnancy within the first 3 months after randomization
- •Poor tolerability to venepuncture or lack of adequate venous access for required blood sampling
- •Current participation in >60 min/week of purposeful exercise, such as jogging or cycling
- •Participation in another clinical trial for which concurrent participation is deemed inappropriate
- •Any orthopaedic implants (hip, knee, spine)
结局指标
主要结局
Inflammatory Bowel Disease Questionnaire (IBDQ)
时间窗: change in IBDQ from baseline to 6 weeks
The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health).
次要结局
- Concentration of Faecal Calprotectin (FC)(change in FC from baseline to 6 weeks)
- Concentration of Interleukin 12 (IL12)(change from baseline to 6 weeks)
- Concentration of Interleukin 23 (IL23)(change from baseline to 6 weeks)
- Crohn's disease activity index (CDAI)(change in CDAI from baseline to 6 weeks)
- Inflammatory Bowel Disease Fatigue (IBD Fatigue)(change in IBD fatigue from baseline to 6 weeks)
- Hospital Anxiety and Depression (HADS)(change in HADS from baseline to 6 weeks)
- Perceived pain(change in pain from baseline to 6 weeks)
- Estimated Cardiorespiratory fitness(change in estimated maximal oxygen consumption from baseline to 6 weeks)
- Concentration of Tnf-alpha(change from baseline to 6 weeks)
- Concentration of Interleukin-6 (IL6)(change from baseline to 6 weeks)
- Concentration of Interleuken-10 (IL10)(change from baseline to 6 weeks)
- Concentration of Interleukin 17a (IL17a)(change from baseline to 6 weeks)
- Concentration of Transforming Growth Factor Beta (TGF-Beta)(change from baseline to 6 weeks)