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临床试验/NCT03452319
NCT03452319已完成不适用

Effekt av ökad Fysisk träning i Samband Med Thorakoabdominell Esofaguskirurgi

Göteborg University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
6 minutes walk test

研究概览

简要总结

Thoracoabdominal oesophageal resection for cancer is a procedure with high risks for complications, and patients' preoperative status is a crucial factor for outcome. There are only a few studies that evaluate the effect of preoperative intervention, including physical exercises and breathing exercises, after this type of surgery.

The aim of the study is therefore to evaluate the effect of a training intervention before resection of the oesophagus.

One hundred patients scheduled for oesophagus resection according to Ivor-Lewis from five different hospitals in Sweden will be included. The patients will be randomized to an intervention group or a control group. The training intervention starts directly after preoperative radiotherapy and chemotherapy are given and lasts until three months postoperatively.

Intervention includes increased physical activity, strength training and respiratory muscle training.

At inclusion and three months after discharge, the patients will undergo tests of physical function and lung function. In addition, they will fill in questionnaires concerning level of physical function, level of physical activity and quality of life. These questionnaires will also be answered one year after surgery.

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
Single (Investigator)

盲法说明

Assessor will not be aware of which group the patients are included in.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients scheduled to undergo thoracoabdominal oesophagus resection at one of the five included centra

排除标准

  • < two weeks between inclusion and surgery
  • benign reason for surgery
  • difficulties in speaking and reading Swedish
  • other injury or disease limiting the ability to perform the intervention.

结局指标

主要结局

6 minutes walk test

时间窗: From inclusion to 3 months postoperatively

Test of physical capacity

次要结局

未报告次要终点

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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