Pregnancy RelatedNCT03467321
Balance, Pulmonary Function, and Low Back Pain in Pregnant and Non-pregnant Women
An observational study of Pregnancy Related, run by Seyda TOPRAK CELENAY at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Physical characteristic assessment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2017to 29 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant and non pregnant women
Who may be able to join
- pregnant women (in the second and third trimester), non-pregnant women, aged between 18 and 40 years, volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pregnancy Related
- Being tested
- Physical characteristic assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical characteristic assessmentOther
Physical characteristics related to balance, pulmonary function and low back pain were evaluated
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical characteristic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance with the one leg balance test was assessed
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
Pulmonary function
Pulmonary function with a spirometer was assessed
Measured: through study completion, an average of 6 months
Low back pain
Low back pain with the Visual Analogue Scale was assessed
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Aug 2017
- Primary completion1 Nov 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seyda TOPRAK CELENAY
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- Seyda Toprak Celenay, Study director, Ankara Yildirim Beyazıt UniversityYasemin Karaaslan, Principal investigator, Beykent UniversityMete Gurol Ugur, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467321
- Sponsor's protocol ID
- 2017/176
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Professor, Physioterapist, PhD
- ClinicalTrials.gov ID
- NCT03467321
- Acronym / sponsor ID
- 2017/176
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Seyda TOPRAK CELENAYUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant group | – | Other: Physical characteristic assessmentBalance 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. |
| Non-pregnant group | – | Other: Physical characteristic assessmentBalance 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant and non pregnant women
Key inclusion criteria (1 listed)
- pregnant women (in the second and third trimester), non-pregnant women, aged between 18 and 40 years, volunteering to participate in the study
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical characteristic assessmentPhysical characteristics related to balance, pulmonary function and low back pain were evaluated | Other | Non-pregnant group, Pregnant group |
Primary outcome
Balance
Time frame: through study completion, an average of 6 months
Balance with the one leg balance test was assessed
2 secondary outcomes
Pulmonary function
Time frame: through study completion, an average of 6 months
Low back pain
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyda Toprak Celenay study director
Ankara Yildirim Beyazıt University
Yasemin Karaaslan principal investigator
Beykent University
Mete Gurol Ugur principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Seyda TOPRAK CELENAY at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.