The Effects of Exercise on Outcomes in Patients Undergoing Surgery for Colorectal Cancer: a Pilot Prospective Randomised Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Length of stay
研究概览
简要总结
Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the mainstay of curative therapy. With the screening program enabling early detection, surgery plays an important role in treatment strategies. Surgery imparts a significant physiological and psychological stress on cancer patients.Recent research has demonstrated that a fast-track approach utilising regional anaesthesia, early mobilisation and good oral intake can improve outcomes by reducing the physiological stress response to surgery. The primary objective of this study is to determine whether a defined exercise programme can improve recovery and reduce complications after surgery.
详细描述
Study Design
This will be a prospective and randomised pilot clinical trial. For purposes of pragmatism, subjects and investigators will not be blinded to treatment allocation. The study is not blinded because it is impossible to blind investigators or patients to the exercise programme.
Patients undergoing major resectional surgery for colorectal cancer will be recruited from the Academic Surgical unit (ASU), Castle Hill Hospital. In total, 60 participants will be recruited for this pilot study and randomly allocated into 2 groups as outlined below.
The study will necessitate all participants being involved in a baseline assessment which will take on average 60 minutes with patients attending Castle Hill Hospital. Travel costs will be met.
All participants will be asked for a 15 ml blood samples on entry into the study and at 24-48 hrs prior to surgery. Regardless of recruitment, blood samples are necessary for clinical purposes at these stages in all patients as part of routine preoperative assessment prior to colorectal surgery. The aim of this is to permit an analysis of possible changes in antioxidant status prior to surgery but after preconditioning. This would be in addition to routine blood samples required.
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
- 否
入选标准
- •Adult patients with colorectal cancer listed for elective resection surgery who have consented to participate in the study.
排除标准
- •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
- •Uncontrolled asthma
- •Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
- •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
- •Preexisting severe physical disability
- •Age <18 years
- •Unwilling to allow their GP to be informed of their participation in the study
结局指标
主要结局
Length of stay
时间窗: Up to 3 months
Post-operative hospital length of stay until medically fit for discharge.
次要结局
- Antioxidant capacity(Up to 4 weeks)
- Quality of Life Questionnaires(Up to 3 months)
- Exercise capacity(Up to 3 months)
- Complications(Up to 3 months)