Randomized Trial of Exercise Training in Postmenopausal Patients With Hormone-receptor Positive Breast Cancer Undergoing Treatment With Aromatase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pathologic ergometry
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypertension
- •COPD > II
- •Active opportunistic infection
- •NYHA heart failure III or IV
结局指标
主要结局
Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.
时间窗: after 6 months
次要结局
- Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis(after 6 and 12 months)
- 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(after 6 and 12 months)