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CompletedNCT03467321Updated Mar 16, 2018

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

An observational study in Pregnancy Related, sponsored by Seyda TOPRAK CELENAY. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-16.

Sponsored by Seyda TOPRAK CELENAY · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
75
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Pregnancy Related
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

pregnant and non pregnant women

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

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
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
75 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • OtherPhysical characteristic assessment

    Physical characteristics related to balance, pulmonary function and low back pain were evaluated

05

What researchers measure

Primary outcomes

  1. Balance

    Balance with the one leg balance test was assessed

    Time frame: through study completion, an average of 6 months

Secondary outcomes

  1. Pulmonary function

    Pulmonary function with a spirometer was assessed

    Time frame: through study completion, an average of 6 months

  2. Low back pain

    Low back pain with the Visual Analogue Scale was assessed

    Time frame: through study completion, an average of 6 months

06

Study locations

1 site
  • Ankara Yildirim Beyazit University
    Ankara, Turkey
07

Registry details

Key details

Study ID
NCT03467321
Lead sponsor
Seyda TOPRAK CELENAY
Responsible party
Seyda TOPRAK CELENAY (Asist. Prof, PT, PhD, Ataturk Training and Research Hospital) — Sponsor-investigator
First posted
Mar 16, 2018
Start date
Aug 1, 2017
Primary completion
Nov 1, 2017
Completion
Dec 29, 2017
Last update
Mar 16, 2018

Study contacts

Seyda Toprak Celenay
study director · Ankara Yildirim Beyazıt University
Yasemin Karaaslan
principal investigator · Beykent University
Mete Gurol Ugur
principal investigator · University of Gaziantep

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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