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临床试验/NCT03336229
NCT03336229Unknown不适用

The Effect of Home-based Prehabilitation on the Cardiorespiratory Fitness of High-risk Colorectal Cancer Patients Awaiting Surgery

NHS Greater Glasgow and Clyde4 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
72
试验地点
4
主要终点
Change in cardiorespiratory fitness

研究概览

简要总结

This study examines whether a home-based telephone-guided preoperative exercise programme is feasible and effective in improving cardiorespiratory fitness in patients with colorectal cancer who are high risk due to their existing co-morbidity.

详细描述

Preoperative exercise, also know as prehabilitation, has been shown to improve physical fitness and potentially reduce postoperative complications in patients undergoing surgery. Patients are often labelled high risk for surgery due to their existing ill-health e.g. heart and lung disease. High risk patients comprise approximately 12% of all elective cancer cases, but account for 80% of all post-operative mortality. Complications significantly affect the quality of life of each CRC patient, both in the short and long-term, and can also impact on survival. It is critical that patients who are deemed at high risk of complications are optimised in the preoperative period. Exercise in the period before surgery is therefore one potential method of improving high risk patients' physical fitness levels while potentially reducing their risk of postoperative complications and subsequent mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (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
否

入选标准

  • •Primary operable colorectal cancer;
  • •Awaiting surgery with curative intent;
  • •Deemed high risk by the responsible clinical team;
  • •Ability to mobilise independently

排除标准

  • •Patients with primary or recurrent inoperable colorectal cancer.
  • •Patients undergoing preoperative chemo- and/or radiotherapy.
  • •Patients who decline or are deemed unfit for operative management.
  • •Patients who lack capacity to consent.

研究组 & 干预措施

Control

No Intervention

Intervention

Active Comparator

干预措施: Exercise intervention (Behavioral)

结局指标

主要结局

Change in cardiorespiratory fitness

时间窗: Preoperative period: 4 weeks

Anaerobic threshold as measured by CPET

次要结局

  • Hospital length of stay(Postoperative period: within 30 days.)
  • Survival(3 years post-operatively.)
  • Health-related quality of life(Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).)
  • Readmission rate(Within 30 days of discharge.)
  • Post-operative morbidity(Post-operative period: at 30 days post-surgery (week 8).)
  • Psychological health(Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).)
  • Frailty(Baseline (week 0) and repeat testing (week 4).)
  • Length of stay in high dependency and intensive care(Postoperative period: up to 8 weeks)
  • Readmission to critical care(Postoperative period: up to 8 weeks (within index admission))
  • Time to medical discharge(Postoperative period: up to 8 weeks.)
  • Redox blood samples(Baseline (week 0) and repeat CPET (week 4).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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