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临床试验/NCT02354430
NCT02354430已完成不适用

AquaMama - Testing the Effect of a Public Water-exercise Program on Low Back Pain and Sick Leave Among Healthy Pregnant Women

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
516
试验地点
2
主要终点
Low back pain Rating Scale

研究概览

简要总结

To investigate the possible effect of an unsupervised water-exercise program, on the intensity of low back pain and the number of days spent on sick leave, among healthy pregnant women Our hypothesis is, that 45 minutes of water exercise twice a week for a period of 12 weeks during pregnancy, will reduce the intensity of low back pain and the days spent on sick leave.

详细描述

Low back pain occurs frequently during pregnancy. Studies show prevalence from 50 to 70% of all pregnant women indicating a general problem. Low back pain increases with gestational age and has been shown to be an important contributing factor to sick leave during pregnancy. Low back pain also has a negative impact on the ability to perform daily chores. It is therefore important to focus on how to prevent or reduce low back pain in pregnant women. Some studies suggest that exercise decreases the pain intensity of low back pain during pregnancy.

However, most women reduce the intensity of exercise and time spent exercising during pregnancy, and many women do not exercise, despite both national and international recommendation advising pregnant women to be physically active at a moderate intensity level for at least 30 minutes per day. The reason for this reduction in physical exercise level can be attributed to the growing body, pregnancy complications or a sense of insecurity while exercising. Exercise such as swimming and exercising in water have been shown to be increasingly used during pregnancy, because pregnant women feel comfortable and safe performing exercises in water. Two randomized intervention studies found that water-exercise during pregnancy can diminish low back pain and reduce the number of days spent on sick leave. In both studies, the intervention was supervised in groups and took place during the day at a scheduled time. These results indicate that supervised water-exercise may have a beneficial effect on healthy pregnant women.

In Denmark, an unsupervised water exercise program for healthy pregnant women, AquaMama, was implemented in public swimming pools in 2011. However, there is no evidence on the effect of unsupervised water exercise programs on the intensity of low back pain and the number of days spent on sick leave. We therefore developed an unsupervised individual water exercise program on the basis of AquaMama supplemented with supportive components to be tested in a randomized controlled trial.

Recruitment Pregnant women are recruited from the Department of Obstetrics, Rigshospitalet, Copenhagen, Denmark. The women are selected on the basis of their due date to time the water exercise intervention from the 20th to 32nd weeks of gestation. The women eligible for participation are invited to participate by a mailed invitation send by post with an enclosed description of the project. After one week the women are contacted by telephone or email and invited to an interview, a physical examination of the pelvic and to fill out a baseline questionnaire.

Intervention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy, pregnant women giving birth at Rigshospitalet, Copenhagen
  • With a single foetus.
  • Gestational weeks 16-17.

排除标准

  • Medical or obstetrical conditions contraindicating physical activity.
  • Women who are diagnosed in the present pregnancy or have formerly been diagnosed with pelvic girdle syndrome.
  • BMI > 29 kg/m
  • Non-Danish speaking.
  • Women with substance abuse problems.

结局指标

主要结局

Low back pain Rating Scale

时间窗: At 12 weeks, after initiating the exercise-program

three numeric 11 point box scales (pain now, worst pain in the past two weeks, average pain in the past two weeks), 0 indicating no pain to 10 indicating worst pain imaginable.

次要结局

  • Sick leave (Number of days spend on leak leave, due to pregnancy-related complications, sickness with no relation to the pregnancy, or due to the work environment)(At 12 weeks, after initiating the exercise-program)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanne Kristine Hegaard

Ph.D

Rigshospitalet, Denmark

研究点 (2)

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