Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
Patients with inflammatory bowel disease (IBD) suffer from a diminished quality of life compared to healthy adults. This is due to the chronic course of disease accompanied with diarrhea, stomach pains but also with psychological stress.
It is known that physical education may improve course of disease and quality of life in a multitude of diseases. These include coronary heart disease, malignancies and also depression. The investigators believe that sport is as effective supportive tool in improving quality of life in IBD patients. But data is lacking with regard to controlled randomized clinical trials. Because of the small amount of data available the investigators considered a feasibility study. Our hypothesis is that IBD patients will cope with moderate exercise. The investigators further suspect that these patients improve their quality of life compared with patients in the control group.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Bayern
-
München、Bayern、德国、81675
- Klinikum rechts der Isar
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- >18 years
- proven colitis ulcerosa (CU)
- proven crohns disease (CD)
- diagnosis >= 1 year before start of the study
- low or moderate disease activity
Exclusion Criteria:
- < 18 years
- high disease activity
- regular exercise > 2 hours per week
- diagnosis of CU oder CD < 1 year before start of the study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Intervention
Patients of the intervention arm receive a 10 week exercise program
|
10 weeks physical exercise; three times a week
|
|
无干预:Control
Patients of the control arm do not participate in exercise
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
生活质量
大体时间:10周
|
10周
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
disease activity
大体时间:10 weeks
|
10 weeks
|
合作者和调查者
调查人员
- 首席研究员:Peter Klare, MD、II. Medizinische Klinik, Klinikum rechts der Isar München, Germany
- 研究主任:Wolfgang Huber, MD、II Medizinische Klinik, Klinikum rechts der Isar München, Germany
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.