Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy
2020年3月16日 更新者：Caty Gilles、Cliniques universitaires Saint-Luc- Université Catholique de Louvain
The aim of this study is to assess the impact of a high-intensity aerobic training and resistance training on fatigue in prostate, head and neck and rectum cancer patients undergoing radiotherapy.
A three-arm randomized controlled trial will be conducted. Patients will be randomised into either a high-intensity aerobic training group or a resistance training group or a control group. Participants in the training groups will exercised for five to eight weeks. Exercise sessions will be take place 3 days per week under the supervision of an experienced therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence syndrome, insomnia, depression symptoms.
研究概览
研究类型
介入性
注册 (实际的)
78
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
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-
-
Brussels、比利时、1200
- Cliniques Universitaires Saint-Luc
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-
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
18年 及以上 (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 :
- a primary diagnosis of prostate cancer, head and neck cancer (oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland) or rectum cancer;
- age over 18 years;
- no distant metastases and/or disease progression;
- at least 25 scheduled radiation treatments (5 weeks);
- ability to read, write, and speak French.
Exclusion criteria :
- uncontrolled cardiac, hypertensive or pulmonary diseases,
- uncontrolled insulin-dependent diabetes mellitus,
- neuropsychiatric disorders or orthopaedic conditions that would impair exercise participation
- abnormal electrocardiogram.
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：治疗
- 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 |
|---|---|
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无干预：控制组
日常护理
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实验性的：High-intensity aerobic training group
High intensity interval training
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High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.
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有源比较器：Resistance training group
Muscle strengthening
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Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).
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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 fatigue
大体时间：Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Fatigue is measured by FACIT-fatigue questionnaire
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Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in functional capacity
大体时间：Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Functional capacity is measured by 6-minute walk test
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Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Change in quality of life
大体时间：Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Quality of life is measured by Functional Assessment of Cancer Therapy-General
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Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Change in sleep disturbances
大体时间：Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Sleep disturbances are measured by Pittsburgh Sleep Quality Index
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Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Change in somnolence syndrome
大体时间：Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Somnolence syndrome is measured by Epworth Sleepiness Scale
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Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Change in insomnia
大体时间：Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Insomnia is measured by Insomnia Severity Index
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Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Change in depression symptoms
大体时间：Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Depression symptoms are measured by Center for Epidemiologic Studies Depression Scale
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Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Change in executive functions
大体时间：Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Executive functions is measured by the Trail Making Test
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Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Change in dyspnea
大体时间：Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Dyspnea is measured by Multidimensional Dyspnea Profile
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Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
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Adherence
大体时间：Weekly through the intervention (during 8 weeks)
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Percentage of completed sessions
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Weekly through the intervention (during 8 weeks)
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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。
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。
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)
2017年8月15日
初级完成 (实际的)
2019年9月1日
研究完成 (实际的)
2019年9月20日
研究注册日期
首次提交
2017年7月31日
首先提交符合 QC 标准的
2017年8月16日
首次发布 (实际的)
2017年8月17日
研究记录更新
最后更新发布 (实际的)
2020年3月17日
上次提交的符合 QC 标准的更新
2020年3月16日
最后验证
2020年3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.