Acute Effects of Exercise on Breast Cancer Biomarkers (ACE) Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in Plasminogen activator inhibitor type-1 (PAI-1) level
研究概览
简要总结
This trial studies how a 45-minute bout of acute exercise in women with a history of breast cancer can affect factors associated with breast cancer and help doctors learn more about how exercise can help prevent breast cancer.
In an earlier part of the study, investigators looked at the effects of the same intervention in women without a history of cancer.
详细描述
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo a moderate-intensity acute exercise bout over 45 minutes.
ARM II: Participants rest by sitting for 45 minutes.
EXTENSION: After completion of initial study recruitment and data collection, an extension was approved in 2023.
EXTENSION OUTLINE: Participants are randomized to 1 of 2 arms.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
All study personnel other than the statisticians and exercise physiologist will be masked to participant study arm
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Plasminogen activator inhibitor type-1 (PAI-1) level
时间窗: Baseline up to 45 minutes
Will compare changes in PAI-1 level from baseline to 45 minutes between the exercisers and controls.
Change in PAI-1 level
时间窗: Baseline up to 105 minutes
Will compare changes in PAI-1 level from baseline to 105 minutes between the exercisers and controls.
Change in Vascular Endothelial Growth Factor (VEGF) level
时间窗: Baseline up to 45 minutes
Will compare changes in VEGF level from baseline to 45 minutes between the exercisers and controls.
Mean change in homeostatic model assessment of insulin resistance (HOMA-IR)
时间窗: Baseline up to 45 minutes
Will compare the average changes in HOMA-IR from baseline to 45 minutes between the exercisers and controls.
Mean change in HOMA-IR
时间窗: Baseline up to 105 minutes
Will compare the average changes in HOMA-IR from baseline to 105 minutes between the exercisers and controls.
Change in insulin level
时间窗: Baseline up to 105 minutes
Will compare changes in insulin level from baseline to 105 minutes between the exercisers and controls.
Change in glucose level
时间窗: Baseline up to 105 minutes
Will compare changes in glucose level from baseline to 105 minutes between the exercisers and controls.
Change in VEGF level
时间窗: Baseline up to 105 minutes
Will compare changes in VEGF level from baseline to 105 minutes between the exercisers and controls.
Change in Irisin level
时间窗: Baseline up to 105 minutes
Will compare changes in Irisin level from baseline to 105 minutes between the exercisers and controls.
次要结局
- Effects of exercise on HOMA-IR in normal-weight participants(At 45 minutes)
- Effects of exercise on HOMA-IR in overweight/obese participants(At 45 minutes)
- Change in C-reactive protein (CRP)(Baseline up to 105 minutes)
- Change in Monocyte chemotactic protein (MCP)-1(Baseline up to 105 minutes)
- Change in Interleukin (IL)-6(Baseline up to 105 minutes)