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临床试验/NCT01048762
NCT01048762已完成2 期

Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial

Aalborg University Hospital2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
78
试验地点
2
主要终点
Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT

研究概览

简要总结

The purpose of this investigation is to determine the effects of exercise training on quality of life and physical capacity, 3 months and 1 year after radical operation for pulmonary cancer.

详细描述

Patients who are radically operated for pulmonary cancer report suffering from respiratory problems, mostly dyspnoea, 5 years after operation. Dyspnoea restricts their physical capability and leads to poorer physical, social and mental wellbeing. The effects of training programs on physical and mental wellbeing for cancer patients are well documented. Most of the studies are though performed on patients suffering from breast, colon and prostate cancer. There are only few studies addressing patients with pulmonary cancer. They are mostly focused on short term effects of exercise training on quality of life, with no control group included in the trials. These studies target patients after different forms for treatment, including surgery, chemotherapy and radiation. There is no data referring to quality of life of patients who are radically operated for pulmonary cancer.

Comparison: multidisciplinary group intervention consisting of exercise training and dyspnoea counseling, 10 times, once a week, compared with one instruction in exercise training and dyspnoea counseling. Exercise training is given by a physiotherapist. Both groups receive in addition standard treatment, which is up to 3 counseling sessions with a nurse.

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
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

入选标准

  • patients who are radically operated for pulmonary cancer at Aalbor Hospital, Aarhus University Hospital

排除标准

  • not radically operated
  • cannot speak and read Danish
  • cannot cooperate in tests due to poor mental health
  • patients who undergo rehabilitation at other centres
  • cannot perform walking test due to physical impairment

结局指标

主要结局

Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT

时间窗: 4 months after inclusion

次要结局

  • Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC)(4 months and 1 year after inclusion)
  • Changes in selv reported quality of life and physical capacity 1 year after inclusion, measured by SF-36 and 6MWT(1 year after inclusion)

研究者

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

Barbara C. Brocki

Physiotherapist

Aalborg University Hospital

研究点 (2)

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