Regular Exercise Among Women at Risk for Preeclampsia

有先兆子痫风险的女性定期锻炼

• 批准号: 6640774
• 负责人: SEONAE YEO
• 金额: $ 30.7万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-01 至 2006-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6640774
• 关键词: antioxidants; cardiovascular disorder therapy; clinical trials; disease /disorder proneness /risk; erythrocytes; exercise; female; human subject; human therapy evaluation; lipid peroxides; low density lipoprotein; oxidative stress; patient oriented research; preeclampsia; superoxide dismutase; vascular endothelium; women's health

DESCRIPTION (Applicant's abstract): Preeclampsia, the sudden onset of high blood pressure along with proteinuria during pregnancy, is a serious complication affecting nearly one in every 20 pregnancies. It is the main cause of maternal death worldwide, and affects women of all races and socioeconomic groups. Unfortunately, no definitive preventive treatment is currently available for this ominous disease. Scientists now believe that preeclampsia is a disease of the endothelium, due in part to oxidative stress. As such, regular exercise has emerged as a potential preventive measure. This contrasts to daily low dose aspirin or calcium supplement which have failed to demonstrate a significant effect and may have adverse effects. The purpose of this study is to determine if moderate intensity exercise during pregnancy will reduce the incidence of preeclampsia and to assess the process (involving oxidative stress and antioxidant process) hypothesized to explain the effect of exercise on preeclampsia. This is a randomized clinical trial with a total of 250 pregnant subjects at risk for preeclampsia. Eligible subjects will enter a run-in period (i.e., qualifying period) at 14 to 18 weeks gestation. Baseline data to be obtained include demographic information, health history, daily physical activities, cardiovascular fitness level, blood pressure, blood sample for serum iron, transferrin, low density lipoprotein, malondialdehyde, superoxide dismutase. At 18 weeks, compliant subjects will be randomly assigned to either the exercise (40 min., 70 percent VO2max, 5x/week) or sham exercise (control group; 10 min. stretch exercise, 5x/week) condition. For both groups, all baseline measurements will be repeated at 28 weeks (Outcome I). Subjects will continue the exercise regimen after 28 weeks up to her term and as long as it is safe and comfortable. A blood sample will be collected again during labor (Outcome II). Subjects who undergo cesarean section for obstetrical reasons will provide a small amount of subcutaneous tissue at the time of incision to measure endothelial superoxide dismutase. Medical records will be reviewed for additional outcome data (pregnancy/birth outcomes and diagnosis of preeclampsia). Chi-square tests of association and logistic regression analysis will be applied to address the effect of exercise, prediction of preeclampsia, and other pregnancy outcomes. Repeated Measures ANOVA will be applied to assess the effect of exercise on various biological markers. ANCOVA will be applied to control confounding factors.

描述（申请人摘要）：先兆子痫，突然发作的高 怀孕期间的血压和蛋白尿是一个严重的问题 近每 20 次妊娠中就有 1 次出现并发症。这是主要原因 全世界孕产妇死亡的比例，并影响所有种族和社会经济地位的妇女 组。不幸的是，目前尚无明确的预防性治疗方法 可用于治疗这种不祥的疾病。科学家现在认为先兆子痫是 一种内皮疾病，部分原因是氧化应激。因此，定期 锻炼已成为一种潜在的预防措施。这与日常形成鲜明对比 低剂量阿司匹林或钙补充剂未能证明 显着影响并可能产生不良影响。本研究的目的是 确定怀孕期间中等强度的运动是否会减少 先兆子痫的发生率并评估该过程（涉及氧化应激） 和抗氧化过程）假设解释运动对 先兆子痫。这是一项随机临床试验，共有 250 名孕妇参加 有先兆子痫风险的受试者。符合条件的科目将进入磨合期 （即，合格期）在妊娠 14 至 18 周。基线数据为 获取的内容包括人口统计信息、健康史、每日体检 活动、心血管健康水平、血压、血液样本 血清铁、转铁蛋白、低密度脂蛋白、丙二醛、超氧化物 歧化酶。 18 周时，符合要求的受试者将被随机分配至 锻炼（40 分钟，70% 最大摄氧量，5 次/周）或假锻炼（对照 团体; 10分钟伸展运动，5 次/周）条件。对于这两个组，所有 基线测量将在 28 周时重复（结果 I）。受试者将 28 周后继续锻炼直至足月，只要 安全又舒适。分娩时将再次采集血样 （结果二）。因产科原因接受剖腹产的受试者 将在切口时提供少量皮下组织 测量内皮超氧化物歧化酶。医疗记录将被审查 额外的结果数据（怀孕/出生结果和诊断 先兆子痫）。关联卡方检验和逻辑回归分析 将用于解决运动的影响、先兆子痫的预测、 和其他妊娠结局。将应用重复测量方差分析来评估 运动对各种生物标志物的影响。 ANCOVA 将应用于 控制混杂因素。