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临床试验/NCT03689634
NCT03689634已完成3 期

Move For Surgery - A Novel Preconditioning Program to Optimize Health Before Thoracic Surgery: A Randomized Controlled Trial

St. Joseph's Healthcare Hamilton1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年10月15日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
102
试验地点
1
主要终点
The primary outcome of the comparative trial will be length of stay (LOS) in hospital after surgery, which will also be used to measure speed of recovery from surgery and postoperative complications.

研究概览

简要总结

Lung cancer is the leading cause of cancer death in Canada. Most patients with this cancer will undergo treatment with major chest surgery that is associated with serious complications. As many as 50% of patients will suffer respiratory complications after surgery, keeping them in the hospital for extended periods of time. These long hospitalizations have a dramatic negative effect on the lives of those people, in addition to a large cost burden on our healthcare system. Traditionally, patients who suffer from complications are treated with rehabilitation AFTER the complications have occurred. But what if complications can be prevented BEFORE they happen? Having major chest surgery imposes great stress on the human body, one that is equivalent to running a marathon. Analogous to training before completing a marathon, the investigator designed Move For Surgery (MFS), a novel preconditioning program that encourages and empowers patients to improve their health prior to surgery. The investigator aims to demonstrate that patients who train with Move For Surgery will have lower respiratory complication rates, will recover better, and will leave the hospital sooner than their counterparts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, 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

  • •Age ≥ 18 years
  • •Clinical stage I, II, or IIIa non-small cell lung cancer (NSCLC)
  • •Candidates for thoracic surgery, as determined by the operating surgeon

排除标准

  • •Clinical stage IIIb or IV NSCLC
  • •Patients with affected mobility (wheelchair, walker)
  • •Patients who use oxygen at home

研究组 & 干预措施

Standard Preoperative Care Group

No Intervention

Move For Surgery Preconditioning Program Intervention Group

Experimental

干预措施: Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group (Device)

结局指标

主要结局

The primary outcome of the comparative trial will be length of stay (LOS) in hospital after surgery, which will also be used to measure speed of recovery from surgery and postoperative complications.

时间窗: 24 months

LOS is a good surrogate measure for the speed of recovery from surgery (patients who recover faster leave hospital earlier) and postoperative complications (patients who do not suffer complications leave the hospital earlier).

次要结局

  • Secondary outcome will include differences in the 36-Item Short Form Health Survey (SF-36) scores before and after the intervention.(24 months)

研究者

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

Wael Hanna

Associate Professor of Surgery

McMaster University

研究点 (1)

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