Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Difference from baseline in the evaluation of fatigue
研究概览
简要总结
The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The beneficial role of a regular physical activity on the quality of life of patients having an IBD was demonstrated in 5 studies including only 1 controlled one [Bilski, on 2013]. The mechanism by which the physical activity could improve the quality of life of the patients remains unknown (stress decreased, reduction of the inflammatory process) [Bilski, on 2014]. Several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated the beneficial effect of a regular physical exercise to reduce the fatigue of patients. It was recently demonstrated that the chronic fatigue observed in patients with IBD came along with a physical reduction in the performances during the exercise test and a reduction in the physical activity of the patients [Vogelaar, 2015].
Our hypothesis is that a regular moderate physical activity could improve physical performance during an effort et could reduce the chronic fatigue and improve their quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old
- •Patients suffering from IBD
- •Patients with a FACIT score < 30
- •Patients with BD in remission with a C-reactiv protein dose < 5
- •Patients with Hemoglobin dosage > 10g/dl
- •Patients with 18<BMI<30 kg/m2
- •Informed consent given by the patients
- •Patients affiliated to the social security
- •Patients living not far from the centre where the rehabilitation program will be performed
- •Women with no risk of pregnancy (menopausal women or with contraceptive drugs).
排除标准
- •Patients ≥ 45 years old
- •Inability to walk or to ride a bike
- •Contraindication to practice physical exercise
- •Contraindication to exercise test
- •Participation to another research study within the week preceding the beginning of the protocol
- •Patients unstable smokers
- •Patients unable to keep their medical treatment stable along the study
- •Patients with a regular intensive physical practice
- •Patients with depression (HAD>11/21)
- •Patients with bad sleep quality (PSQI score >5)
- •Pregnant or breast-feeding patients
- •Patients under legal protection
研究组 & 干预措施
chronic quiet inflammatory bowel disease patient (IBD)
Patient with chronic quiet inflammatory bowel disease patient (IBD) with regular and moderate physical activity
干预措施: regular and moderate physical activity (Other)
chronic quiet inflammatory bowel disease patient (IBD)
Patient with chronic quiet inflammatory bowel disease patient (IBD) with regular and moderate physical activity
干预措施: No regular and moderate physical activity more than usual (Other)
chronic quiet inflammatory bowel disease Patient (IBD)
Patient with chronic quiet inflammatory bowel disease patient (IBD) with no regular and moderate physical activity more than usual
干预措施: regular and moderate physical activity (Other)
chronic quiet inflammatory bowel disease Patient (IBD)
Patient with chronic quiet inflammatory bowel disease patient (IBD) with no regular and moderate physical activity more than usual
干预措施: No regular and moderate physical activity more than usual (Other)
结局指标
主要结局
Difference from baseline in the evaluation of fatigue
时间窗: 3 Month
Evaluation of fatigue using FACIT questionnaire
次要结局
- Difference from baseline in the Evaluation of the Quality of life(3 Month)