The Impact of Different Physical Exercise Protocols on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 主要终点
- Improvement of cardio-vascular efficiency
研究概览
简要总结
To examine the effects of different physical exercise protocols (aerobic training and resistance training) on cardio-vascular efficiency and quality of life in a population of breast cancer survivors (BCS), not treated with chemotherapy.
详细描述
The present study enrolled a population of BCS women who underwent surgical treatment for breast cancer at the "Ospedale G. Bernabeo" of Ortona, Chieti, Italy. The participants were randomized to the following physical exercise protocols: aerobic training, walking or Nordic walking; resistance training.
All the participants have been examined utilizing transthoracic echocardiography, carotid ultrasound and photo-plethysmographic method for the analysis of arterial stiffness, before and after the physical exercise protocol (T0-T1). The two-dimensional speckle-tracking analysis was performed with an offline, dedicated software from the apical 4-chambers-view. Moreover, ventricular-arterial coupling, epicardial fat thickness and intima-media thickness were also analyzed.
Quality of life was assessed using SF-36 score at T0, T1 and at a mean follow-up of 34 months. Moreover, at follow-up, we evaluated spontaneous physical activity and cardiovascular quality of life using IPAQ and SAQ-7 scores.
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 (Investigator)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age < 65 years;
- •history of breast cancer surgery in the previous 12 months;
- •no history of chemotherapy;
- •no ongoing radiotherapy;
- •eventual hormonal therapy;
- •cardiovascular and orthopedic eligibility.
排除标准
- •adjuvant chemotherapy;
- •any history of cardiovascular disease;
- •abnormal exercise stress test at the screening;
- •any systemic inflammatory disease or any orthopedic condition potentially limiting the physical training.
结局指标
主要结局
Improvement of cardio-vascular efficiency
时间窗: 12-weeks (from the beginning of physical exercise training)
A composite of the improvement in the following parameters, from pre-treatment values: global longitudinal strain analysis, as assessed by speckle-traking echocardiography; ventricular-arterial coupling, as assessed by echocardiographic single beat method; arterial stiffness (pulse wave velocity, augmentation index), as assessed by photoplethysmographic method
次要结局
- Epicardial fat thickness reduction(12-weeks (from the beginning of physical exercise training))
- Intima-media thickness reduction(12-weeks (from the beginning of physical exercise training))
- Improvement of quality of life(12-weeks (from the beginning of physical exercise training); a mean of 34 months from the enrollment)
- Improvement of spontaneous physical activity(a mean of 34 months from the enrollment)
- Improvement of cardiovascular quality of life(a mean of 34 months from the enrollment)
研究者
Francesco Bianco
Researcher
ITAB - Institute for Advanced Biomedical Technologies