Fitness, Activity and Lung Cancer Study (FALC)
2019年2月9日 更新者：Elisabeth Edvardsen、Oslo University Hospital
Cardiorespiratory Fitness and Effect of Training After Lung Cancer Surgery. A Randomized Controlled Trial
The purpose of the study is to investigate the change in pulmonary function and exercise capacity in lung cancer patients after pulmonary resection.
Furthermore, to study the effect of training on aerobic capacity, muscular strength, morbidity and survival.
Physical activity level by accelerometers, body composition by DXA and quality of life will also be reported.
研究概览
详细说明
Five year after surgery, all included patients will be reinvited to undergo a fourth health excame to study the long-term effects of exercise training on physical fitness, morbidity and survival.
研究类型
介入性
注册 (实际的)
71
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Oslo、挪威、0450
- Oslo University Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 79年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Non smal cell lung cancer
- Patient living in Oslo or Akershus county and accepted for lung cancer surgery at Oslo University hospital and Akershus University hospital
- were able to read and speak Norwegian
Exclusion Criteria:
- Mental incompetence or physical disability that makes it difficult to walk on a treadmill
- Treatment or medical complications affecting ability to participate in an exercise group
- > 79 years
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Physical training
Exercise intervention.
|
Physical training three times a week for 20 week including endurance and strength training compare to the "as usual" group as controls
|
|
其他：As usual
Controls
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Controls, not training
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Maximal oxygen uptake (VO2max) from baseline
大体时间：An expected average of two weeks before surgery (baseline), four to six weeks after surgery, after six months and after 5 years
|
Change in VO2max from before to after surgery to measure the effect of surgery, and after six months to measure the effect of high-intensity training intervention, and after five years to study long-term effects
|
An expected average of two weeks before surgery (baseline), four to six weeks after surgery, after six months and after 5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Pulmonary function from baseline
大体时间：Pulmonary function is measured three times; an expected average of two weeks before surgery, four to six weeks after surgery, after after six months and after five years.
|
Change in pulmonary function from before to after surgery and after the intervention
|
Pulmonary function is measured three times; an expected average of two weeks before surgery, four to six weeks after surgery, after after six months and after five years.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
DXA scan
大体时间：An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years
|
Change in body composition from before to after surgery and after the intervention
|
An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years
|
|
Quality of life
大体时间：Measured three times: An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years
|
Change in quality of life from before to after surgery and after the intervention
|
Measured three times: An expected average of two weeks before surgery, four to six weeks after surgery, after six months and after five years
|
|
Physical activity
大体时间：Measured three times: six weeks after surgery, after six months and after five years
|
Physical activity will be objectively measured by accelerometers for seven consecutive days to determine change in activity level after surgery
|
Measured three times: six weeks after surgery, after six months and after five years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Elisabeth Edvardsen, PhD、Oslo University Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Edvardsen E, Skjonsberg OH, Holme I, Nordsletten L, Borchsenius F, Anderssen SA. High-intensity training following lung cancer surgery: a randomised controlled trial. Thorax. 2015 Mar;70(3):244-50. doi: 10.1136/thoraxjnl-2014-205944. Epub 2014 Oct 16.
- Edvardsen E, Anderssen SA, Borchsenius F, Skjonsberg OH. Reduction in cardiorespiratory fitness after lung resection is not related to the number of lung segments removed. BMJ Open Sport Exerc Med. 2015 Oct 5;1(1):e000032. doi: 10.1136/bmjsem-2015-000032. eCollection 2015.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年11月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2018年6月20日
研究注册日期
首次提交
2011年8月8日
首先提交符合 QC 标准的
2012年12月11日
首次发布 (估计)
2012年12月13日
研究记录更新
最后更新发布 (实际的)
2019年2月12日
上次提交的符合 QC 标准的更新
2019年2月9日
最后验证
2019年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.