Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients
Exercise Intervention in Pregnancy for Reduction of Blood Pressure in Obese Gravidas
研究概览
详细说明
Hypertension affects 5-10 percent of pregnancies, and complications from hypertensive disorders of pregnancy are the third leading cause of maternal death in the United States. Hypertensive disorders of pregnancy, including preeclampsia, lead to preterm delivery, morbidity and mortality of mother, fetus, and neonate, and are a predictor of development of chronic maternal hypertension, cardiovascular disease, and renal disease. Maternal obesity is increasing dramatically in the patient population, and is an independent risk factor for hypertension and preeclampsia, increasing the risk by two- to four-fold. To date, no effective preventative measure has been found to reduce the risk of preeclampsia or hypertension in high risk pregnant patients. However, observational studies have shown that patients who exercise or who have increased physical activity before and during pregnancy have lower rates of preeclampsia, hypertension, and gestational diabetes. Exercise has been shown in numerous studies to be safe in pregnancy, and is recommended by the American College of Obstetrics and Gynecology as part of routine prenatal care. However, aerobic exercise can be viewed by patients to be difficult to perform during pregnancy, particularly when the patient is obese and at later gestations. Adherence to exercise regimens is therefore low in this patient group. Dynamic resistance training has been shown to lower mean blood pressure both acutely and long term in non-pregnant hypertensive patients, and can be performed more easily by patients with mobility issues. This intervention has not been studied in an obese pregnant population for its effects on blood pressure throughout pregnancy.
The long term goal is to develop an intervention that will reduce the barriers to exercise of obese pregnant women that will, in turn, reduce their risk of developing preeclampsia and other hypertensive disorders of pregnancy. The specific objective of this proposal is to study the effect of a structured resistance training exercise intervention on blood pressure in obese pregnant woman, who would be considered high risk for development of hypertensive disorders based on pre-pregnancy BMI. The central hypothesis is that obese pregnant patients who participate in a regular, structured resistance training exercise regimen will have a decrease in mean arterial blood pressure compared to obese pregnant patients who are strongly encouraged to do aerobic exercise (lifestyle intervention) or who participate in routine prenatal care. The investigators formulated this hypothesis, in part, based upon previous studies found in the literature performed in non-pregnant hypertensive patients. The investigators will extrapolate from the experience and methods of the collaborators, who have studied the effects of exercise on gestational diabetes.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- Penn State Milton S. Hershey Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient's BMI must be ≥ 30 and ≤ 40.
- Established viable singleton pregnancy <13 weeks
Exclusion Criteria:
- Multiple gestations.
- Maternal diabetes established pre-pregnancy by standard guidelines
- Congenital or acquired heart disease
- Use of antihypertensive medication
- Inability to exercise
- Restrictive lung disease
- History of shortened/incompetent cervix
- History of preterm labor
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:运动干预
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Group C (exercise intervention) will be given the ACOG pamphlet on exercise in pregnancy, a daily activity log, a pedometer, a resistance band, and a handout on specific exercises (type and frequency) to be performed.
The study coordinator will demonstrate each exercise and then observe the participant perform each exercise to assure full understanding.
In addition to wearing the pedometer for 7 days and completing the activity log, this group will also record compliance with the exercise regimen.
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无干预:Routine prenatal care
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实验性的:Exercise support
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Group B (exercise support) will be given the ACOG pamphlet on exercise in pregnancy, a daily activity log, and a pedometer.
This group will be asked to wear the pedometer for 7 consecutive days between Visits 1 and 2, and record daily activities.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change in mean arterial blood pressure
大体时间:<13 weeks gestation-postpartum visit
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<13 weeks gestation-postpartum visit
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次要结果测量
结果测量 |
措施说明 |
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蛋白尿
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Hypertension of pregnancy or preeclampsia
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Gestational weight gain
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Neonatal weight
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Serum markers for hypertension risk
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Activity level
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Measured with activity logos
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Number of steps per week
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Pedometer measurement
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Weight retention at postpartum visit
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Mode of delivery
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Vaginal versus cesarean
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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