Exercise Training in Postmenopausal Patients With Breast Cancer
Randomized Trial of Exercise Training in Postmenopausal Patients With Hormone-receptor Positive Breast Cancer Undergoing Treatment With Aromatase Inhibitors
This randomized trial aims to assess if a well defined subgroup of breast cancer patients benefit from a controlled physical activity program.
All patients will be screened for their physical ability to complete the interventional exercise program. Only patients capable and willing to take part in this study and meeting all inclusion and exclusion criteria will be randomized.
All patients are to receive identical counseling for ideal nutritional, life-style and physical activity.
Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Salzburg、奥地利、5020
- Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Signed informed consent
- Postmenopausal women with hormone receptor positive breast cancer (as defined by HR >= ++ and/or PR >= ++) who are treated with aromatase inhibitors
- ECOG performance status <= 2
- all age groups
Exclusion Criteria:
- Pathologic ergometry
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- COPD > II
- Active opportunistic infection
- NYHA heart failure III or IV
学习计划
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Counseling
Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity.
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Nutritional, lifestyle and sports counseling
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实验性的：Controlled physical activity
All patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity. Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home. |
counseling and controlled physical activity
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.
大体时间：after 6 months
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after 6 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis
大体时间：after 6 and 12 months
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after 6 and 12 months
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Evaluation of the influence of controlled/observed physical activity versus lifestyle counseling only on Fitness level, Quality of Life, rate of infections, weight, body mass index BMI, Body fat percentage
大体时间：after 6 and 12 months
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after 6 and 12 months
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合作者和调查者
合作者
调查人员
- 研究主任：Richard Greil, Prof.Dr.、Arbeitsgemeinschaft medikamentoese Tumortherapie
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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