NCT02189356

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

July 10, 2014

Last Update Submit

July 12, 2014

Conditions

PregnantPregnancy-related Low Back and Pelvic Pain

Keywords

Pregnancy-related low back and pelvic painexercise programnurse

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    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).

    4 weeks

Secondary Outcomes (1)

  • The Oswestry Disability Index

    4 weeks

Study Arms (2)

exercise programme

EXPERIMENTAL

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

contol group

OTHER

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

Interventions

exercise programmeBEHAVIORAL

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

exercise programme
standard careBEHAVIORAL

standard pregnancy follow up

contol group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Ozdemir S, Bebis H, Ortabag T, Acikel C. Evaluation of the efficacy of an exercise program for pregnant women with low back and pelvic pain: a prospective randomized controlled trial. J Adv Nurs. 2015 Aug;71(8):1926-39. doi: 10.1111/jan.12659. Epub 2015 Mar 31.

    PMID: 25823561DERIVED

MeSH Terms

Conditions

Pelvic Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, RN

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 14, 2014

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 15, 2014

Record last verified: 2014-07