Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Peak arterio-venous oxygen content difference
研究概览
简要总结
The chemotherapy medications used for breast cancer treatment are important for achieving a cure, but a potential side effect is that they can cause a decline in functional capacity (reduced exercise tolerance and impaired physical function) and increase the risk of cardiovascular disease. The risks of decreased functional capacity and cardiovascular disease are highest in breast cancer survivors as they grow older. The factors causing the decline in functional capacity are not well understood, however they may be related to a reduction in cardiac function (e.g. decreased pumping ability of the heart) or skeletal muscle function (reduced muscle blood flow and oxygenation). Exercise training is used for other populations at risk for cardiovascular disease (such as cardiac rehabilitation), but is not routinely offered to breast cancer survivors. Therefore this research study wants to test whether exercise training can improve heart and muscle health, and increase functional capacity in up to 60 older breast cancer survivors aged >60 years old who previously received chemotherapy drugs that can affect the heart.
The purpose of this study is to compare two rehabilitation approaches: a 12-week structured exercise training program or a 12-week stretching-yoga program. The investigators want to compare whether these programs can improve functional capacity, and heart and skeletal muscle function. To do this, some of the participants in this study will be randomly enrolled in the structured exercise training program and others will be randomly enrolled in the stretching-yoga program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
All MRI outcomes will be performed blinded to group allocation. Outcome assessors for post-outcome assessments will be blinded to baseline values.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years
- •Previously diagnosed with early-stage (I-III) BC
- •Completed (≥1 year post) primary cardiotoxic treatment (anthracycline-based chemotherapy or trastuzumab-based biological therapy).
排除标准
- •Have a history of coronary artery disease, heart failure, persistent and permanent arrhythmia (e.g. currently in atrial fibrillation), stroke, or chronic obstructive pulmonary disease
- •Develop signs or symptoms of myocardial ischemia (≥1mm horizontal or down-sloping ST segment depression on electrocardiogram) during the cardiopulmonary (VO2peak) test
- •Have any research MRI contraindications (e.g. any type of pacemaker), or any orthopedic limitation preventing exercise testing
- •Currently performing structured exercise training (defined as ≥30 mins/day of moderate-to-vigorous aerobic and/or resistance exercise training on ≥4 days/week)
- •Are unwilling to be randomized to either ExT or STRETCH
结局指标
主要结局
Peak arterio-venous oxygen content difference
时间窗: 12 Weeks
Peak exercise arterio-venous oxygen content difference assessed using whole-body exercise MRI
Peak cardiac output
时间窗: 12 Weeks
Peak exercise cardiac output assessed using whole-body exercise MRI
次要结局
- Physical Function(12 Weeks)
- Peak volume of oxygen uptake(12 Weeks)
- Peak diffusive muscle oxygen conductance(12 Weeks)
- Peak stroke volume(12 Weeks)
- Aerobic endurance(12 Weeks)
- Skeletal muscle volume(12 Weeks)
- Skeletal muscle myosteatosis(12 Weeks)
- Skeletal muscle fibrosis(12 Weeks)
- Calf muscle aerobic capacity(12 Weeks)
- Calf muscle oxygen extraction(12 Weeks)
- Calf muscle oxygen diffusive conductance(12 Weeks)
- Calf muscle metabolism(12 Weeks)
- 10-year Framingham Risk Score(12 Weeks)