- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06677346
Parity and Respiratory Muscle Strength in Women
Investigating the Relationship Between Parity and Respiratory Muscle Strength in Women.
Study Overview
Status
Conditions
Detailed Description
In normal anatomical structure, there is myofascial continuity between the diaphragm, abdominal muscles and pelvic floor muscles. In addition to this anatomical unity, when the diaphragm muscle descends with inhalation, the pelvic floor muscle moves caudally, allowing breathing to encounter less resistance; the opposite occurs during exhalation.
Pregnancy and childbirth create anatomical and physiological changes in the female body. As a result of the growing uterus, the diaphragm moves upwards, while the pelvic floor muscles become depressed as intra-abdominal weight increases. On the other hand, it is thought that increased ligament laxity is responsible for changes in the body's muscle structure, especially in the lower body. Considering these pregnancy-related changes, the functions of these interrelated muscle groups may be affected and synergistic movements in the woman's body may be disrupted after pregnancy.
The aim of this study is to examine whether the anatomical structures affected during pregnancy have permanent effects on respiratory muscle strength and core muscles after birth. Volunteers who agree to participate in the study will be divided into groups according to their birth counts and respiratory and core muscles will be evaluated using objective methods.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Imge NAS
- Phone Number: +902124984141
- Email: i.nas@iku.edu.tr
Study Locations
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Istanbul, Turkey
- Recruiting
- Istanbul Kultur University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being between 20-45 years old
- Being female
Exclusion Criteria:
- Having a body mass index of ≥30 kg/m2
- History of cardiovascular, neurological, pulmonary disease
- Being receiving active cancer treatment
- Having a history of lumbar surgery
- History of smoking
- Being a licensed athlete
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Nulliparous
Women who have never given birth
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Primiparous
Women who have given birth once
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Multiparous
Women who have given birth multiple times
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory Muscle Strength/ maximal inspiratory pressure (MIP)
Time Frame: On the day of enrollment
|
Participants' maximal inspiratory pressure (MIP) measurements will be evaluated using the COSMED Pony FX spirometry device according to American Thoracic Society/European Respiratory Society standards.
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On the day of enrollment
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Respiratory Muscle Strength/maximal expiratory pressure (MEP)
Time Frame: On the day of enrollment
|
Participants' maximal expiratory pressure (MEP) measurements will be evaluated using the COSMED Pony FX spirometry device according to American Thoracic Society/European Respiratory Society standards.
|
On the day of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Biofeedback Unite
Time Frame: On the day of enrollment
|
Core muscle stabilization will be measured with The Stabilizer Pressure Biofeedback Unit.
Individuals are asked to lie down in the supine and prone positions.
After the pressure cell of the instrument is placed with reference to the Anterior superior iliac spines (ASIS) and Posterior superior iliac spines (PSIS), the subjects are asked to perform a drawing-in maneuver.
The contraction that can be sustained for 10 seconds is recorded in mmHg.
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On the day of enrollment
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Trunk Muscle Endurance Tests
Time Frame: On the day of enrollment
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The endurance of the trunk flexor, trunk extensor and lateral flexor muscles is evaluated by recording the maximum time that the person can maintain the test position.
|
On the day of enrollment
|
|
Physical Activity Level
Time Frame: On the day of enrollment
|
Individuals' physical activity levels will be questioned with the International Physical Activity Questionnaire (IPAQ) Short Form.
It is a 7-item scale.
Physical activity levels are classified into 3 categories according to the scores obtained by multiplying the duration, frequency and MET values of the physical activities that the participants participated in within 7 days and for at least 10 minutes.
Accordingly, <600 MET - min/week is defined as inactive, 600 - 3000 MET - min/week low, and >3000 MET - min/week is defined as sufficient physical activity level.
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On the day of enrollment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- İK-2023-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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