Parity and Respiratory Muscle Strength in Women

November 5, 2024 updated by: Imge NAS, Medipol University

Investigating the Relationship Between Parity and Respiratory Muscle Strength in Women.

The aim of this study is to investigate the relationship between parity and respiratory muscle strength in women.

Study Overview

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

Observational

Enrollment (Estimated)

60

Contacts and Locations

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

Study Contact

Study Locations

      • Istanbul, Turkey
        • Recruiting
        • Istanbul Kultur 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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The participant group of the research will consist of women between the ages of 20-45 and participation will be based on volunteering.

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

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
Nulliparous
Women who have never given birth
Primiparous
Women who have given birth once
Multiparous
Women who have given birth multiple times

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.
On the day of enrollment
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.
On the day of enrollment
Trunk Muscle Endurance Tests
Time Frame: On the day of enrollment
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.
On the day of enrollment

Collaborators and Investigators

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

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)

June 14, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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