An Investigation Into the Role of Cardiopulmonary Exercise Testing and Pre-operative Exercise Training in Patients Undergoing Major Surgery for Colorectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- postoperative morbidity
研究概览
简要总结
Colorectal Surgery Preoperative Exercise Training is a study being run by the colorectal surgery team at the Norfolk and Norwich University Hospital and the University of East Anglia to look at the role of exercise before surgery to improve recovery following an operation.
Having an operation to remove part of the bowel puts physical stress on the body. We know that training can help the body cope with physical stress in the same way that an athlete trains before a competition. We hypothesise that the body may recover more quickly if it is trained prior to an operation with regular and simple exercises.
Cardiopulmonary exercise testing (CPET) is used to evaluate the function of the lungs, heart and muscles at rest and during exercise. CPET testing is often done as part of standard pre-operative assessment in many hospitals for patients before undergoing major surgery. Some studies have demonstrated that CPET can be used to predict outcomes following surgery (such as time taken till discharge, complication rates).
The study consists of two parts:
Study 1) CPET variables to predict outcomes in surgery - patients will undergo a CPET test to determine baseline fitness. Blood tests will be taken around the time of surgery to examine whether biochemical markers in the bloodstream (when used in combination with results from the CPET test) can predict outcomes and recovery following colorectal surgery. Patients will then be monitored to assess their speed of recovery and rate of complications following surgery.
This will enable us to determine which CPET variables or combination of variables are most useful in the prediction of post-operative complications following colorectal surgery.
- The second study will consist of an exercise intervention involving several sessions of supervised exercise in a laboratory. Before and at the end the exercise training regime, CPET measurements will be taken to see if fitness has improved with exercise.
This part of of the study is to determine if it is feasible to implement a structured, supervised exercise programme for patients awaiting elective colorectal cancer surgery. The results of this study will be used to inform a larger randomised controlled trial to examine the influence of exercise on CPET variables and postoperative outcomes.
详细描述
The study will be conducted in two parts:
Part 1. Study to examine the ability of CPET to predict outcomes in patients undergoing colorectal surgery:
Objectives
To identify which CPET variables or combination of variables are most useful in the prediction of post-operative complications following colorectal surgery. In addition, to examine whether CPET variables can be used in combination with other scoring systems or blood tests to increase accuracy of prediction. The aim of this investigation is to develop an accurate prediction model from key clinically relevant predictor variables, including CPET variables, blood tests and risk scoring systems. Such a model could be used in clinical practice to predict pre-operative outcome and thus help risk stratify patients for post-operative surveillance or management.
Study Population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •Written informed consent
- •Colorectal malignancy suitable for curative resection, no metastatic disease
- •Elective procedure, ability to undergo CPET testing
- •American Society of Anaesthesiologists (ASA) physical status I-III
排除标准
- •Emergency surgery
- •Unable to participate due to any of the following absolute contraindications to CPET testing: acute MI in past 3 - 5 days; Unstable angina; Uncontrolled arrhythmias; Syncope; Active endocarditis; Symptomatic severe aortic stenosis; Acute PE; DVT; Uncontrolled asthma; Pulmonary oedema; Room air desaturation at rest <85%; Respiratory failure; Cognitive impairment leading to inability to cooperate
- •Distant metastases on CT
- •American Society of Anaesthesiologists (ASA) physical status IV
研究组 & 干预措施
Exercise Training Arm
Patients randomised to exercise training will be offered three sessions of aerobic interval exercise per week over the subsequent 4 weeks prior to their procedure. Each session will comprise 6 x 5 min repetitions at 60-80% peak VO2, with 2.5 min rest intervals. The aim will be to quickly progress patients to exercise intensities that correspond to and exceed the individual AT. Heart rate, clinical signs, blood pressure and perceived exertion will be recorded regularly throughout exercise.
Repeat CPET testing will then take place 4 weeks from the baseline test in the exercise laboratory (on the day prior to surgery) to determine changes (if any) in AT, VO2, VE/VCO2.
干预措施: Exercise training (Behavioral)
No Exercise Training Arm
The patients in the non-exercise arm of the study will not undergo any exercise intervention but will be CPET tested in the exercise laboratory at the same time points as the exercise arm patients.
结局指标
主要结局
postoperative morbidity
时间窗: First 30 days following surgery
Patient notes will be reviewed on each postoperative day to identify incidence of postoperative complications according to the Post-Operative Morbidity Survey system (POMS), a validated 18-item scoring tool which assesses nine domains of morbidity relevant to the post-surgical patient according to precisely defined criteria (pulmonary, infection, renal, gastrointestinal, cardiovascular, wound complications, haematological and pain.
次要结局
- mortality(30 days)
- Admission to HDU/ITU(30 days)
- post-operative stay(30 days)