NCT03467321

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

March 5, 2018

Last Update Submit

March 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Balance

    Balance with the one leg balance test was assessed

    through study completion, an average of 6 months

Secondary Outcomes (2)

  • Pulmonary function

    through study completion, an average of 6 months

  • Low back pain

    through study completion, an average of 6 months

Study Arms (2)

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

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

Non-pregnant groupPregnant group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant and non pregnant women

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR
  • Yasemin Karaaslan

    Beykent University

    PRINCIPAL INVESTIGATOR
  • Mete Gurol Ugur

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asist. Prof, PT, PhD

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 16, 2018

Study Start

August 1, 2017

Primary Completion

November 1, 2017

Study Completion

December 29, 2017

Last Updated

March 16, 2018

Record last verified: 2018-03

Locations