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: 6539394
• 负责人: SEONAE YEO
• 金额: $ 30.78万
• 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/6539394
• 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 妊娠期高血压和蛋白尿，是一种严重的 几乎每20个孕妇中就有一个有并发症。这是主要原因。 世界范围内孕产妇死亡的影响，并影响到所有种族和社会经济的妇女 组。不幸的是，目前还没有明确的预防性治疗方法。 可用于这种不祥的疾病。科学家现在认为先兆子痫是 氧化应激一种部分由氧化应激引起的内皮疾病因此，定期的 运动已经成为一种潜在的预防措施。这与《每日》形成了鲜明对比。 小剂量阿司匹林或补钙未能证明 影响显著，并可能产生不利影响。本研究的目的是 确定在怀孕期间进行中等强度的运动是否会减少 先兆子痫的发生率和评估过程(包括氧化应激 和抗氧化过程)来解释运动对 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。合格的受试者将进入磨合期 (即资格期)在怀孕14至18周时。基准数据将为 获得的信息包括人口统计信息、健康史、日常体检 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 歧化酶。在18周后，符合条件的受试者将被随机分配到 运动(40min，70%最大摄氧量，5次/周)或假运动(对照组 组：10min。伸展运动，5次/周)条件。对于这两组人，都是 基线测量将在28周时重复(结果一)。研究对象将 在28周后继续锻炼，直到她的任期结束 既安全又舒适。分娩期间将再次采集血样 (结果二)。因产科原因接受剖宫产的受试者 会在切开时提供少量的皮下组织 测定内皮细胞超氧化物歧化酶。医疗记录将被审查，以 其他结果数据(妊娠/出生结果和诊断 先兆子痫)。关联性卡方检验与Logistic回归分析 将被应用于解决运动的影响，预测先兆子痫， 和其他妊娠结局。重复测量方差分析将应用于评估 运动对各种生物标志物的影响。ANCOVA将应用于 控制混杂因素。