High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Percent completed vs. planned exercise duration
研究概览
简要总结
Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients based on biological sex
- •18 to 85 years of age
- •diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer
- •completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy, and bisphosphonates are allowed within 6 months of study enrollment and during study participation
- •absence of contraindications to exercise or to participate in study
- •study clinician approval
排除标准
- •do not meet inclusion criteria
- •scheduled to receive surgery or radiation therapy during the intervention period
- •any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
- •lymphedema stage ≥2 prior to study enrollment
- •are pregnant
- •current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
研究组 & 干预措施
Usual Care (UC)
Research participants will continue their habitual physical activity for the duration of the study. Once they complete the study, they will have the opportunity to perform supervised HIIT or MICT at home for 3 days/week for 12 weeks (research participants can choose either type of exercise).
干预措施: 12-week Intervention Period (Behavioral)
Usual Care (UC)
Research participants will continue their habitual physical activity for the duration of the study. Once they complete the study, they will have the opportunity to perform supervised HIIT or MICT at home for 3 days/week for 12 weeks (research participants can choose either type of exercise).
干预措施: 12-week Observation Period (Behavioral)
High Intensity Interval Training (HIIT)
Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
干预措施: 12-week Intervention Period (Behavioral)
High Intensity Interval Training (HIIT)
Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
干预措施: 12-week Observation Period (Behavioral)
Moderate Intensity Continuous Training (MICT)
Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
干预措施: 12-week Intervention Period (Behavioral)
Moderate Intensity Continuous Training (MICT)
Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
干预措施: 12-week Observation Period (Behavioral)
结局指标
主要结局
Percent completed vs. planned exercise duration
时间窗: Throughout the 12 weeks of supervised home-based exercise training
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
Change in brachial FMD
时间窗: Baseline, Following a 12-week intervention period, Following a 12-week observation period
Flow-mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia.
Change in cardiac function (global longitudinal strain)
时间窗: Baseline, Following a 12-week intervention period, Following a 12-week observation period
Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction.
Percent completed vs. planned exercise frequency
时间窗: Throughout the 12 weeks of supervised home-based exercise training
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
Percent completed vs. planned exercise intensity
时间窗: Throughout the 12 weeks of supervised home-based exercise training
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.
Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention
时间窗: Throughout the 12 weeks of supervised home-based exercise training
To evaluate safety plans are in place for determination and monitoring of adverse events according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions.
次要结局
未报告次要终点