Effect of Physical Exercise Program on Fetoplacental Growth
2019年6月24日 更新者：Marina Vargas Terrones、Universidad Politecnica de Madrid
Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial
The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.
研究概览
研究类型
介入性
注册 (实际的)
124
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Madrid、西班牙、28040
- Universidad Politécnica de Madrid
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Torrejón, Hospital Universitario de Puerta de Hierro or Hospital Universitario Severo Ochoa (Madrid)
Exclusion Criteria:
- Multiparity
- Obstetrician complications
- Being interested in the study after 18 weeks
- Not having availability to attend to the physical exercise program
- Younger than 18 years old
- Older than 45 years old
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control Group
Pregnant women not participating in supervised physical exercise program.
The subjects in this group will be monitored during pregnancy to know if they make any kind of exercise on your own, to know which are really sedentary pregnant women.
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实验性的：Exercise Group
Pregnant women participating in supervised physical exercise program.
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Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (before week 16 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training. Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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胎盘重量
大体时间：交货时
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交货时
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Fetal birth weight
大体时间：At delivery
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At delivery
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Change from baseline in maternal gestational weight
大体时间：38-42 weeks of gestation
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Maternal weight gain during pregnancy.
Weight will be measured at the beginning and at the end of the pregnancy
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38-42 weeks of gestation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pregestational weight and Body Mass Index (BMI)
大体时间：Before pregnancy
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Before pregnancy
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pH umbilical cord
大体时间：At delivery
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At delivery
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Fetal size outcomes
大体时间：At delivery
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Size and height, head circumference and body mass index of the baby
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At delivery
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Fetal glycemia level
大体时间：At delivery
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At delivery
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Apgar score
大体时间：At delivery
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Apgar score will be valued 1 and 5 minutes after delivery
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At delivery
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Maternal delivery outcomes (composite)
大体时间：At delivery
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Type of labor, stage and duration of labor
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At delivery
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Postpartum depression
大体时间：0-12 postpartum months
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The level of maternal depression after delivery will be measured with the Edinburgh Postnatal Depression Scale (EPDS)
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0-12 postpartum months
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Changes from baseline in prenatal depression
大体时间：Up to 36 weeks
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The level of maternal depression during pregnancy will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the Center for Epidemiologic Studies Depression Scale (CES-D)
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Up to 36 weeks
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Changes from baseline in maternal quality of life
大体时间：Up to 36 weeks
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Maternal quality of life will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the Short Form-36 Health Survey (SF-36)
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Up to 36 weeks
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Changes from baseline in urinary incontinence
大体时间：Up to 36 weeks
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Urinary incontinence will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)
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Up to 36 weeks
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Gestational diabetes
大体时间：24-28 weeks
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Gestational diabetes will be measured with the O' Sullivan's test
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24-28 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Rubén Barakat Carballo, PhD、Universidad Politécnica de Madrid.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
- Vargas-Terrones M, Barakat R, Santacruz B, Fernandez-Buhigas I, Mottola MF. Physical exercise programme during pregnancy decreases perinatal depression risk: a randomised controlled trial. Br J Sports Med. 2019 Mar;53(6):348-353. doi: 10.1136/bjsports-2017-098926. Epub 2018 Jun 13.
- Barakat R, Vargas M, Brik M, Fernandez I, Gil J, Coteron J, Santacruz B. Does Exercise During Pregnancy Affect Placental Weight?: A Randomized Clinical Trial. Eval Health Prof. 2018 Sep;41(3):400-414. doi: 10.1177/0163278717706235. Epub 2017 Apr 25.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年11月1日
初级完成 (实际的)
2016年12月1日
研究完成 (预期的)
2021年12月1日
研究注册日期
首次提交
2015年4月8日
首先提交符合 QC 标准的
2015年4月16日
首次发布 (估计)
2015年4月17日
研究记录更新
最后更新发布 (实际的)
2019年6月25日
上次提交的符合 QC 标准的更新
2019年6月24日
最后验证
2019年6月1日
更多信息
与本研究相关的术语
其他研究编号
- INEF-001
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.