Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study
研究概览
详细说明
Participants will be randomised into one of two groups. One group of participants will be asked to increase their level of activity by gradually walking further (the exercise group) and the other group will carry on with their usual level of activity (the usual activity group) .
Assessments People in both groups will have an assessment on 3 occasions: when they join the study, just before surgery and 3 months after surgery.
This assessment involves:
Walking for 6 minutes up and down a corridor to see how far they can walk. Asking them for some information about their medical history Completing three questionnaires about how they are feeling and their quality of life.
People who are randomised to the exercise group will be advised about how many steps to take based on how they did in the initial walking assessment. The number of days or weeks they will be asked to take a daily walk will depend on how much time there is between them joining the study and the date of their surgery. We think this will be about 2 weeks.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Yorkshire
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Scarborough、Yorkshire、英国
- Scarborough General Hospital
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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:
- Aged 18 years or older
- Requiring elective resectional bowel surgery
- Gives consent to participate in the study
Exclusion Criteria:
- Younger than 18 years of age.
- A history of unstable angina/unstable coronary artery disease or a heart attack in the previous month.
- Any heart related disease including but not limited to aortic stenosis, pericarditis or any thromboembolic disease.
- Severe Infections and fever.
- Uncontrolled metabolic diseases.
- Resting heart rate of more than 120 BPM.
- Systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg.
- Recent cerebrovascular accident.
- Pregnancy
- Pre-existing severe physical disability.
- Unwilling to allow their GP to be informed of their participation in the study.
- Not able or unwilling to consent to take part in the study
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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 |
|---|---|
|
无干预：控制
无干预
|
|
|
实验性的：Monitored walking based exercise
Participants will be given a personalised daily exercise target.
Participants will be given an activity tracker (a Fitbit ZipTM).
The participants will be asked to wear the device all day to monitor their activity.
Once a day the participants will be asked to complete the walking target they have been given at completion of their baseline assessment.
This target should be completed in one go.
The walking programme will last a minimum of 2 weeks and a maximum duration of 4 weeks.
The length of time will depend on the length of time between recruitment and when the participant is scheduled to have their surgery.
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Monitored walking based exercise
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in fitness as assessed by Six Minute Walk Test
大体时间：Will be done at recruitment, prior to surgery and 3 months post operatively
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Fitness assessment
|
Will be done at recruitment, prior to surgery and 3 months post operatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The EQ-5D
大体时间：Will be done at recruitment, prior to surgery and 3 months post operatively
|
Quality of life assessment
|
Will be done at recruitment, prior to surgery and 3 months post operatively
|
|
EORTC QLC-C30
大体时间：Will be done at recruitment, prior to surgery and 3 months post operatively
|
Quality of life assessment
|
Will be done at recruitment, prior to surgery and 3 months post operatively
|
合作者和调查者
调查人员
- 研究主任：John Macfie, MBChB, MD、York Teaching Hospitals NHS Foundation Trust
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- SNE 2447
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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.