Balance, Pulmonary Function, and Low Back Pain in Pregnant and Non-pregnant Women

March 9, 2018 updated by: Seyda TOPRAK CELENAY

Assistant Professor, Physioterapist, PhD

The aims of this study were to investigate balance and pulmonary functions in pregnant and non-pregnant women and to determine their relationship with LBP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Yildirim Beyazit University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant and non pregnant women

Description

Inclusion Criteria:

  • pregnant women (in the second and third trimester), non-pregnant women, aged between 18 and 40 years, volunteering to participate in the study

Exclusion Criteria:

  • Having a high-risk pregnancy, preeclampsia, multiple pregnancies, gestational diabetes mellitus, hypertension, any physical disability, prior history of surgery related to spine or abdominal, spinal deformity, serious neurological, rheumatologic, cardiopulmonary or psychiatric diseases, malignancy, fracture history, or those having any exercise program or sportive activity in the last 3 months for pregnant women
  • Having any physical disability, spinal or abdominal surgery, spinal deformity, serious neurological, rheumatologic, cardiopulmonary or psychiatric diseases, malignancy, or fracture history, or those having any exercise program or sportive activity in the last 3 months for non-pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant group
Balance with the one leg balance test with the eyes open and closed, pulmonary functions with a spirometer, and LBP with the Visual Analogue Scale (VAS) were assessed.
Other: Physical characteristic assessment
Physical characteristics related to balance, pulmonary function and low back pain were evaluated
Non-pregnant group
Balance with the one leg balance test with the eyes open and closed, pulmonary functions with a spirometer, and LBP with the Visual Analogue Scale (VAS) were assessed.
Other: Physical characteristic assessment
Physical characteristics related to balance, pulmonary function and low back pain were evaluated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: through study completion, an average of 6 months
Balance with the one leg balance test was assessed
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function
Time Frame: through study completion, an average of 6 months
Pulmonary function with a spirometer was assessed
through study completion, an average of 6 months
Low back pain
Time Frame: through study completion, an average of 6 months
Low back pain with the Visual Analogue Scale was assessed
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seyda TOPRAK CELENAY

Investigators

  • Principal Investigator: Yasemin Karaaslan, Beykent University
  • Principal Investigator: Mete Gurol Ugur, University of Gaziantep

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

December 29, 2017

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 16, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2017/176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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