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临床试验/NCT02189356
NCT02189356已完成不适用

Evaluation of the Efficacy of an Exercise Program for Pregnant Women With Low Back and Pelvic Pain: A Prospective Randomized Controlled Trial

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi0 个研究点目标入组 96 人开始时间: 2011年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
主要终点
pain intensity

研究概览

简要总结

The aim of this study was to evaluate the effect of exercise programs on pregnant women with pregnancy-related Low Back and Pelvic Pain (LBPP). Hypotheses of the study were: 1) Exercise programs relieve the intensity of LBPP in pregnant women and 2) Exercise programs promote functional capacity for pregnant women with LBPP.

详细描述

Design The study was a prospective randomized trial with a control group (standard care group) and an intervention group, using a repeated measures design. Forty-eight pregnant participants with pregnancy-related LBPP were included in the control group and 48 pregnant participants with pregnancy-related LBPP were included in the intervention (exercise) group.

Participants This research was performed between December 2011 and May 2012 at the Department of Obstetrics and Gynecology, Gulhane Military Medical Education and Research Hospital in Ankara, Turkey. Approximately 3,000 births occur annually at this clinic. Participants were pregnant women who presented to the obstetrics department for routine pregnancy examinations, had pregnancy-related LBPP and fulfilled the eligibility criteria. Eligibility criteria of the research were determined following a literature review. The eligibility criteria were;

  • Age over 18 years old
  • Ability to read and write in Turkish,
  • Volunteering to participate in the study,
  • Being between 20-35 weeks of gestation,
  • Having no complications for any reason during the study,
  • No diagnosis of low back and/or pelvic disease prior to pregnancy,
  • Not performing exercise for half an hour at least three days a week during pregnancy,
  • Not using analgesics for low back and pelvis pain,
  • Not using other methods for the treatment low back and pelvic pain,
  • Giving birth before the completion of the study Interventions Participants diagnosed with pregnancy-related LBPP by a doctor and with no medical obstacles to participation in the study were directed to nurse. The nurse invited the pregnant women to the research room for a discussion about low back and pelvic pain. After the eligibility criteria of the pregnant women were reviewed, initial assessments were completed and the participants were subsequently randomized.

The nurse gave health counseling to the participants in the intervention group about the prevention of pregnancy-related LBPP and initiated an exercise program that included exercise training. The health counseling and exercise training booklets provided were prepared based on the literature. Each counseling session lasted an average of 45 minutes. Sessions were completed in a positive education atmosphere and were face-to-face as consistent with the principles of adult education. The structure and function of the vertebrae, physical changes occurring during pregnancy, causes of pregnancy-related LBPP, the problems that the pain causes, methods of pain management, correct posture development, body mechanics during activities of daily life and ergonomics were explained to the pregnant women using illustrated booklets given during the trainings. During the counseling, the nurse received information from the participants regarding their daily activities and educated the participants about the behaviors that might damage the low back and pelvic regions. Participants were given practical demonstrations of how to move and how to protect the low back and pelvic regions during daily life. For example, the nurse demonstrated how to retrieve an object from the ground, how to reach shelves, how to sit and stand up and how to lie down, guiding the participants through these activities as well. The participants' questions were answered, and they were given educational booklets. Following the health consultation, exercise education was given. The participants were given illustrated booklets explaining the effects of pregnancy exercises on maternal and fetal health, situations that need attention before starting and during exercises, signs of danger, what should be done in potentially dangerous situations, how to breathe during exercise and the method, frequency and amount of the exercise. The exercises given to the intervention group were based on the guidelines from "Exercise in Pregnancy" by the Royal College of Obstetricians and Gynaecologists (RCOG) and the guidelines from "Pregnancy and Exercise" by Hacettepe University in Turkey. It was emphasized that pregnant women should complete their exercises as shown at least three days a week for 30 minutes. The duration of the exercise program was four weeks. Participants were offered a choice of two types of exercise according to the weather conditions. The first option comprised exercises performed on a mattress, including stretching, tightening and loosening movements that targeted large muscle groups from the neck to the vertebrae. The nurse explained that the mattress exercises would start with a 5 minute warm up, continue for at least 15-20 minutes at mid-tempo and end with a 5 minute cool down. The second option was a walking exercise. The participants were expected to warm up for 5 minutes, increase their speed for 5 minutes, continue at mid-tempo for 15 minutes and complete a 5 minute cool down. It was emphasized that the pulse rate should be between 120-160/min when the participants reached mid-tempo. In this exercise program, we assumed that both the walking exercise and the mattress exercises had equal effects on the low back and pelvic pain. Pregnant women were able to choose the type of exercise according to their wishes and requirements and could use either or both of the exercise options. The nurse determined the exercise plan with the pregnant women, creating an individual exercise program according to the patient's personal characteristics. The participants were asked to record the type and the duration of the completed exercises during the program on the data collection form and were asked to note if they encountered any problems during the program. The nurse taught the participants how to fill out the forms and answered any questions about the programs. The nurse spoke with the pregnant women on the phone three times a week and gave counseling according to their needs. During interviews, pregnant women were reminded to complete the data collection forms. After four weeks, the researchers made a final assessment of the pregnant women and collected the forms during a face-to-face interview. The exercise programs were terminated at this point, though the pregnant women were able to continue the counseling if they wished.

The pregnant women in the control group received usual care, comprised of routine clinical practice for pregnancy-related LBPP. The control group participants were recommended bed rest and analgesics for LBPP and were not given any treatment for LBPP in addition to standard care. Pregnant women in the control group did not exercise before the study or during the study. The nurse spoke with the women in the control group on the phone once a week and asked them to assess their LBPP and complete the data collection form. The final assessments of the participants were made during a face-to-face interview four weeks later. Willing pregnant women in the control group were advised on pain management strategies after completion of the four weeks of the study.

研究设计

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

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age over 18 years old
  • Ability to read and write in Turkish,
  • Volunteering to participate in the study,
  • Being between 20-35 weeks of gestation,
  • Having no complications for any reason during the study,
  • No diagnosis of low back and/or pelvic disease prior to pregnancy,
  • Not performing exercise for half an hour at least three days a week during pregnancy,
  • Not using analgesics for low back and pelvis pain,
  • Not using other methods for the treatment low back and pelvic pain,
  • Giving birth before the completion of the study

排除标准

  • 未提供

结局指标

主要结局

pain intensity

时间窗: 4 weeks

We used the Visual Analogue Scale (VAS) to measure the intensity of the participants' pain. The VAS is a reliable and valid scale that widely used all over the world for the assessment of pain intensity (Wewers \& Lowe 1990, Lindseth \& Vari 2005, Kalus et al. 2008, Potter 2013, Murphy et al. 2009).

次要结局

  • The Oswestry Disability Index(4 weeks)

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serpil Ozdemir, PhD, RN

PhD, RN

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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