Cardiac Rehabilitation to Improve Breast Cancer Outcomes (CRIBCO)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in cardiovascular fitness (as assessed using VO2max) between baseline and after 12 weeks of participation in a tapered 12-week cardiac rehabilitation program.
研究概览
简要总结
To develop a novel, proactive cardiac rehabilitation program for breast cancer survivors at enhanced risk of cardiovascular disease. Considering this program is secondary to the Michigan Medicine Cardiac Rehabilitation program's goal to manage cardiac patients, the hybrid program has been designed that limits utilization of cardiac rehabilitation to 12 visits over the first eight weeks of the intervention compared to 32 visits for cardiovascular patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer diagnosis stage I-III
- •Within 18-months of treatment completion (defined as completion of all oncologic treatments expect oral maintenance therapy)
- •Age 18 years or older
- •At increased risk for cardiovascular disease based on one of the following; a.Treatment with either anthracycline-based or anti-HER2 therapy-based treatment regimen plus the presence of: >2 cardiovascular heart disease risk factors (smoking, hypertension, diabetes mellitus, obesity, dyslipidemia), OR Age (>60 years) at cancer treatment, OR Left ventricular ejection fraction <50%as determined with a clinically ordered echo scan within 6 months of enrollment, b.Treatment with anthracycline followed by trastuzumab
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Planned surgery during the study period.
- •Under cardiology care for known high-risk cardiovascular disease defined as the presence of any of the following: severe, unrevascularized coronary artery disease, severe valvular heart disease, advanced heart failure with a left ventricular ejection fraction <35%)
- •Metastatic cancer
- •Unable to exercise (e.g., inability to complete a modified stress test or musculoskeletal condition that prevents adequate participation in exercise)
- •Adults unable to give consent, pregnant or lactating women, and prisoners are excluded from this study.
研究组 & 干预措施
Cardiac Rehabilitation to Improve Breast Cancer Outcomes
12 weeks of Cardiac Rehab
干预措施: Cardiac Rehab (Other)
结局指标
主要结局
Change in cardiovascular fitness (as assessed using VO2max) between baseline and after 12 weeks of participation in a tapered 12-week cardiac rehabilitation program.
时间窗: up to 12 weeks after enrollment
Change in cardiovascular fitness will be based on endpoints related to aerobic and anaerobic thresholds, including an increase in post maximal oxygen consumption (VO2max). VO2max will be assessed by indirect calorimetry (COSMED) during a graded exercise stress test using the Bruce protocol.
次要结局
- changes in upper body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.(up to 12 weeks after enrollment)
- changes in lower body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.(up to 12 weeks after enrollment)