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临床试验/NCT01523353
NCT01523353已完成1 期

Feasibility Study of Preoperative Exercise Intervention in the Resection of Colorectal Liver Metastasis.

Liverpool University Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
37
试验地点
2
主要终点
Anaerobic threshold prior to liver resection

研究概览

简要总结

Each year in the UK around 1500 patients undergo surgery for bowel cancer that has spread to the liver. This is major surgery that offers a chance of cure, but can be associated with complications. Fitter patients are less likely to have serious complications. We are interested in finding out whether a short exercise program can improve patient fitness before surgery and whether this can reduce surgical complications.

We plan to measure the fitness of patients who are going to have liver surgery. We will then give them an exercise programme for 4 weeks, after which we will assess their fitness again.

We are also interested in whether fitter people have better Liver function. To assess this we will take a small sample of liver tissue during the operation for laboratory analysis of its function.

Hypothesis

  1. A short period of exercise can significantly improve fitness prior to liver surgery
  2. Greater Fitness is associated with better liver function.

详细描述

Prehabilitation in Liver Surgery

Introduction Thirty per cent of patients with colorectal cancer have metastatic disease at time of presentation, and a further 20% will develop liver metastases after the primary colorectal malignancy has been resected. Liver resection offers the prospect of cure for a proportion of these patients and, with the increasing use of effective neo-adjuvant chemotherapy, this proportion is increasing. However, liver surgery is associated with significant morbidity and mortality and this may be higher in patients with comorbidity, poor cardiorespiratory fitness and in those who have received neo-adjuvant chemotherapy.

Cardiopulmonary exercise testing (CPET) is a non-invasive assessment of cardiovascular and pulmonary function, which can be quantified by measures such as anaerobic threshold (AT) and VO2peak. The anaerobic threshold is a measure of sustainable exercise, where the VO2peak is a measure of maximal exercise capacity. The AT has been assessed in different surgical groups and has been shown as a useful predictor of postoperative complications and survival. Early work has demonstrated that short periods of preoperative exercise intervention can improve AT and VO2peak. However, no work has to date been undertaken in patients prior to liver surgery.

Hepatic glucose metabolism provides much of the energy requirements of the postoperative period. Work has demonstrated that exercise training increases hepatic glucose production, and that its inhibition has a marked effect on endurance capability. This may be particularly relevant when surgical resections can involve resection of up to 80% of hepatic tissue. However, a link between hepatic gluconeogenic capacity and fitness as assessed by cardiopulmonary exercise testing has not been established.

A demonstrable link between gluconeogenic capacity and cardiopulmonary fitness and an explanation of its underpinning physiology would help explain some of the systemic effects of drug hepatotoxicity. It would also allow development of strategies to improve gluconeogenic capacity that may reduce complications and improve tolerance of many hepatoxic agents such as chemotherapy.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Planned resection of colorectal liver metastasis
  • Able to perform cycle based exercise program
  • Age over 18

排除标准

  • Unable to consent
  • Unable to perform cycle based exercise program
  • Age under 18

结局指标

主要结局

Anaerobic threshold prior to liver resection

时间窗: 4 weeks

This is a measure of cardiopulmonary fitness as detected by a cardiopulmonary exercise test.

次要结局

  • Hospital Length of stay(6 weeks)
  • Post operative morbidity(3 months)
  • Quality of Life(4 months)
  • Mortality(30 day and 90 day postoperative)
  • Attendance at exercise sessions(6 weeks)
  • Serious adverse events within exercise program(6 weeks)
  • other measures of cardiopulmonary function(6 weeks)
  • Recovery of fitness(6 and 12 weeks post operatively)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Declan Dunne

Surgical Research Fellow

Liverpool University Hospitals NHS Foundation Trust

研究点 (2)

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