Assessing the Effect of an Aerobic Exercise Program on Vascular Function in Women With Non-Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Enrollment (Recruitment rate)
研究概览
简要总结
The goal of this clinical trial is to assess the feasibility of an 8-week aerobic exercise program and its effect on arterial function in breast cancer survivors.
The main questions it aims to answer are:
- Is an 8-week aerobic exercise program feasible in breast cancer survivors after the completion of chemotherapy, immunotherapy and/or anti-HER2 agents?
- Is this 8-week aerobic exercise program beneficial for vascular function in breast cancer survivors?
Participants will:
- Begin an 8-week aerobic exercise program, three days per week, after the completion of chemotherapy, immunotherapy and/or anti-HER2 agents.
- Visit our facility three times: before the exercise program, 1 month after, and after the completion of the program.
- Complete questionnaires, physical functional tests, and body composition and vascular measurements at every visit.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women (18-70 years) with a stage I-III breast cancer diagnosis who have completed chemotherapy, immunotherapy and/or anti-HER2 agents.
- •Able to begin aerobic exercise within 12 weeks of the final chemotherapy, immunotherapy and/or anti-HER2 agents.
- •Sedentary by self-reporting inactivity (<90 min of moderate or vigorous exercise per week)
- •Weight ≤154 kg
- •Willing to complete all study activities
- •Able to safely participate in moderate aerobic exercise.
排除标准
- •Current pregnant and lactating patients. Must have completed lactation prior to study start.
- •Metastatic disease.
- •Diagnosed cardiovascular disease prior to the initiation of cancer therapy, as evidenced by cardiomyopathy (reduced regional or global left ventricular contractility), diastolic dysfunction grade 2 or above, symptomatic coronary artery disease, ejection fraction below 50%.
- •Non-English speaking
研究组 & 干预措施
Exercise Intervention
干预措施: Aerobic Exercise (Other)
结局指标
主要结局
Enrollment (Recruitment rate)
时间窗: From enrollment to immediately after first visit
Enrollment will be measured by the proportion of eligible breast cancer survivors who provide informed consent to participate in the study. The proportion of enrolled participants will be reported.
Participant adherence - Proportion of people considered adherent
时间窗: From enrollment to the end of intervention at 8 weeks
Adherence will be measured as the proportion of exercise sessions completed by consented survivors out of the total of 24 prescribed training sessions. Completion of at least 18 of the 24 training sessions will be considered adherent.
Retention - Proportion of survivors who completed the study
时间窗: From enrollment to the end of intervention at 8 weeks
Retention will be measured by the percentage of consented survivors that completed the research study compared to the total number initially enrolled. The proportion of survivors who completed the study will be reported.
Pulse Wave Velocity
时间窗: From enrollment to the end of intervention at 8 weeks"
This test measures how stiff your arteries are (called pulse wave velocity). Pulse wave velocity is an important measure that can help predict the risk of heart and blood vessel disease. It is a simple, non-invasive test, which means it does not involve needles or anything that goes inside your body. We will use a device called the SphygmoCor XCEL to do the test. To measure this, we will place a small sensor on your neck (over the carotid artery) and a blood pressure cuff on your upper thigh (over the femoral artery). The cuff will inflate slightly while we record your pulse waves. We will also use a tape measure to find the distance between the two spots. This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention.
Aortic Blood Pressure
时间窗: From enrollment to the end of intervention at 8 weeks
We will use a simple, non-invasive test to estimate the aortic blood pressure with a device called the SphygmoCor XCEL. The device measures your blood pressure using a cuff placed on your upper arm. Aortic blood pressure is another test we use to check the health of the heart and blood vessels. This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention.
次要结局
- Blood Pressure(From enrollment to the end of intervention at 8 weeks)
研究者
Georgios Grigoriadis
Assistant Professor
Loyola University