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Effects of Regular Exercise During Pregnancy

Training During Pregnancy - Effects of Regular Exercise During Pregnancy in Prevention of Pregnancy-related Diseases and Complications During Labour. A Randomised Clinical Trial

There is a great lack of results from randomized clinical trials with high methodological quality, assessing the effects of exercise during pregnancy. The main aims of this trial is to study the effects of exercise during pregnancy in the prevention and treatment of disease and complications which may arise during pregnancy:

  • Does regular exercise during pregnancy aid in preventing gestational diabetes?
  • Does regular exercise during pregnancy prevent low back and/or pelvic girdle pain?
  • Does regular exercise during pregnancy prevent urine and/or fecal incontinence?
  • Does regular exercise during pregnancy have an effect on labour and delivery?
  • Does regular exercise during pregnancy prevent maternal excessive weight gain and fetal macrosomatia?

研究概览

详细说明

Pregnancy is regarded as a period of high risk when it comes to development of e.g. excessive weight gain, gestational diabetes and musculoskeletal problems such as low back pain and pelvic girdle pain, and urinary and fecal incontinence. While pregnancy and labor imply these and other risks, exercise is regarded as advantageous during pregnancy. Today's knowledge about the importance of exercise during pregnancy is mainly based on observational data from epidemiological studies, and the scientific strength of the clinical recommendations given is open to question. There is a great lack of results from randomized clinical trials with high methodological quality, assessing the effects of exercise during pregnancy. As a result of this, many important questions are still not answered. One of these is the effect exercise during pregnancy has in the prevention and treatment of disease and complications which may arise during pregnancy. Another question is the consequences that exercise during pregnancy has for labor and delivery. This study is designed as a randomized clinical trial using validated measurement tools to find answers to the mentioned questions.

In both national and international literature the importance of physical activity is highlighted. WHO has recently presented a global strategy for nutrition, physical activity and health. In Norway physical activity and exercise have been strongly addressed, and is an issue of high priority also in pregnant and postpartum women (St.meld.nr.16). Nevertheless, few trials evaluating the effects of regular exercise have been published. There is a need for evidence based knowledge to be implemented in education of health professionals, and in the development of health promotion strategies aiming at the general population.

研究类型

介入性

注册 (实际的)

855

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

      • Trondheim、挪威、7489
        • Department of Community Medicine and General Practice, Norwegian University of Science and Technology and Clinical Service, St Olavs Hospital, Trondheim University Hospital

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 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Pregnant 18 weeks
  • attend the routine ultrasound control at the three hospitals
  • healthy
  • age 18 years or more
  • singleton live foetus at the routine ultrasound scan
  • normal pregnancy.

Exclusion Criteria:

  • pregnancy complications
  • high risk for preterm labour
  • pain during pelvic floor muscle contractions
  • ongoing urinary tract infection
  • diseases that could interfere with participation (following recommendations from SEF 2000, ACOG 2003)
  • living too far from the hospitals to be able to attend weekly exercise groups

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:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:exercise
Regular exercise 45-60 minutes minimum three times per week
a specific training program 12 weeks between pregnancy week 20 and 36. regular exercise 45-60 minutes minimum three times per week.
其他名称:
  • 理疗
  • regular training
  • specific exercises
有源比较器:control
standard antenatal care
standard antenatal care

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
Gestational diabetes
大体时间:20 and 36 weeks pregnancy and 3 months post partum
insulin resistance
20 and 36 weeks pregnancy and 3 months post partum
Gestational diabetes
大体时间:18 months postpartum
Insulin resistance
18 months postpartum

次要结果测量

结果测量
措施说明
大体时间
incontinence
大体时间:20 and 36 weeks of pregnancy, 3 months post partum
Fecal- and urinary incontinence (incontinence scores)
20 and 36 weeks of pregnancy, 3 months post partum
lumbopelvic pain
大体时间:20 and 36 weeks pregnancy and 3 months post partum
Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
20 and 36 weeks pregnancy and 3 months post partum
disability
大体时间:20 and 36 weeks pregnancy and 3 months post partum
Disability Rating Index (Salèn et al. 1994)
20 and 36 weeks pregnancy and 3 months post partum
incontinence
大体时间:18 months postpartum
Fecal- and urinary incontinence (incontinence scores)
18 months postpartum
lumbopelvic pain
大体时间:18 months postpartum
Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
18 months postpartum
disability
大体时间:18 months postpartum
Disability Rating Index (Salèn et al. 1994)
18 months postpartum
Gestational diabetes
大体时间:5 years
insulin resistance
5 years

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

  • 学习椅:Siv Mørkved, PhD、Norwegian University of Science and Technology

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

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

2007年5月1日

初级完成 (实际的)

2011年6月1日

研究完成 (实际的)

2015年6月1日

研究注册日期

首次提交

2007年5月21日

首先提交符合 QC 标准的

2007年5月21日

首次发布 (估计)

2007年5月22日

研究记录更新

最后更新发布 (实际的)

2020年10月5日

上次提交的符合 QC 标准的更新

2020年10月1日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • REK4.2007.81

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.

specific training program的临床试验

3
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