NCT00393172已完成2 期
Women in Steady Exercise Research (WISER)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Changes in urine levels of F2-isoprostanes
研究概览
简要总结
RATIONALE: Exercising regularly may lower the risk of breast cancer.
PURPOSE: This randomized clinical trial is studying how well exercise prevents breast cancer in healthy young women.
详细描述
OBJECTIVES:
Primary
- Compare the changes in urine levels of a stable marker of oxidative stress (F_2-isoprostanes) in healthy young women who undergo exercise training during 4 menstrual cycles vs no exercise.
Secondary
- Assess the changes in other metabolic factors that explain the association between physical activity and breast cancer, including:
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women
- •Self-reported menstrual cycle length of 25-35 days within the past 2 months
- •Nonsmoker
- •Sedentary (exercise < 3 times weekly within the past 6 months)
- •Intact ovaries and uterus
- •No history of gynecological problems (e.g., fibroids, endometriosis, polycystic ovary syndrome)
- •Premenopausal
- •Body mass index 18.5 to 40
- •Stable weight (no changes ≥ 10% within the past year)
排除标准
- •No pregnancy or breast feeding within the past 6 months
- •No plans to become pregnant during study treatment
- •No cancer within the past 5 years except for nonmelanoma skin cancers
- •No medical condition that would prohibit participation in a vigorous program of weight-bearing aerobic exercise including, but not limited to, any of the following:
- •Fibromyalgia
- •Chronic fatigue syndrome
- •Metabolic disorders
- •Recent cardiovascular event
- •Orthopedic limitations
- •Psychiatric disorders requiring antipsychotic drugs
- •No uncontrolled hypertension (systolic blood pressure [BP] > 160 mm Hg and/or diastolic BP > 99 mm Hg)
- •No more than 7 alcoholic beverages per week
- •No injected hormonal contraceptive use within the past year
- •More than 6 months since prior use of intrauterine device
- •More than 3 months since prior oral or patch hormone contraceptives
- •No medication that would prohibit participation in a vigorous program of weight-bearing aerobic exercise
研究组 & 干预措施
exercise
Experimental
5 days per week exercise for 4 months
干预措施: exercise (Behavioral)
no exercise
No Intervention
结局指标
主要结局
Changes in urine levels of F2-isoprostanes
时间窗: Before and after study
次要结局
- Changes in levels of IGF-axis proteins(Before and after study)
- Changes in body composition(Before and after study)
- Changes in insulin and glucose(Before and after study)
- Changes in estrogen metabolites(Before and after study)
研究者
研究点 (2)
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