Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Brachial artery flow-mediated dilation
研究概览
简要总结
The purpose of this study is to determine the effect of regular aerobic exercise on endothelial function in pregnancy.
详细描述
Preeclampsia is a common maternal disease that complicates 5% to 10% of pregnancies and remains as the major cause of maternal and neonatal mortality, especially in developing countries. Cost-effective interventions aimed to prevent the development of preeclampsia are urgently needed. Ethiopathogenesis of preeclampsia involves multiple mechanisms as oxidative stress, endothelial dysfunction, infections, maternal constitutional factors, and others. Regular aerobic exercise recovers endothelial function, decreases oxidative stress and improves maternal constitutional factors.
The purpose of this Controlled Clinical Trial is to determine the effect of regular aerobic exercise on endothelium-dependent brachial artery flow-mediated dilatation. Furthermore, the effect of exercise on biomarkers on vascular function and perinatal outcomes will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past four months are eligible for the trial.
- •Live foetus at the routine ultrasound scan and a normal pregnancy.
- •Gestational age 16 to 20 weeks
- •Written informed consent will be obtained from each woman prior to the inclusion in the study.
排除标准
- •History of high blood pressure
- •Chronic medical illnesses (cancer, renal, endocrinologic, psychiatric, neurologic, infectious and cardiovascular diseases)
- •Persistent bleeding after week 12 of gestation
- •Poorly controlled thyroid disease
- •Placenta praevia, incompetent cervix, polyhydramnios, oligohydramnios
- •History of miscarriage in the last twelve months
- •Diseases that could interfere with participation (following recommendations from ACSM 2000, ACOG 2003).
结局指标
主要结局
Brachial artery flow-mediated dilation
时间窗: Baseline, 8 weeks, 16 weeks
次要结局
- high sensitivity C-Reactive Protein(Baseline, 16 weeks)
- Nitrates, Nitrites and cyclic GMP(Baseline, 16 weeks)
- Blood lipid profile(Baseline, 16 weeks)
- Anthropometric indicators(Baseline, 8 weeks, 16 weeks)
- Functional capacity (VO2 Max)(Baseline, 8 weeks, 16 weeks)
- Maternal and neonatal outcomes(At delivery)