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Gulhane Military Medical Academy Ethical Committee Exercise Program for Pregnant Women With Low Back and Pelvic Pain

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ClinicalTrials.gov Identifier: NCT02189356
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Serpil Ozdemir, PhD, RN, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnant Pregnancy-related Low Back and Pelvic Pain Behavioral: exercise programme Behavioral: standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Efficacy of an Exercise Program for Pregnant Women With Low Back and Pelvic Pain: A Prospective Randomized Controlled Trial
Study Start Date : September 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: exercise programme
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.
Behavioral: exercise programme
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

contol group
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.
Behavioral: standard care
standard pregnancy follow up




Primary Outcome Measures :
  1. pain intensity [ Time Frame: 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).


Secondary Outcome Measures :
  1. The Oswestry Disability Index [ Time Frame: 4 weeks ]
    The Oswestry Disability Index (ODI) was used to determine the participants' functional status. The ODI was developed in 1976 by O'Brien (Fairbank & Pynsent 2000) and is a condition-specific outcome measure used in the management of spinal disorders.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Serpil Ozdemir, PhD, RN, PhD, RN, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
ClinicalTrials.gov Identifier: NCT02189356    
Other Study ID Numbers: 1491-348-11/1539-227
GMMA ( Other Identifier: GMMA )
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014
Keywords provided by Serpil Ozdemir, PhD, RN, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi:
Pregnancy-related low back and pelvic pain
exercise program
nurse
Additional relevant MeSH terms:
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Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms