Respiratory Muscle StrengthNCT06677346
Parity and Respiratory Muscle Strength in Women
An observational study of Respiratory Muscle Strength and Parity, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the relationship between parity and respiratory muscle strength in women. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscle Strength, Parity, Core Stability
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2023to Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Being between 20-45 years old
- Being female
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Kultur University
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Muscle Strength, Parity, Core Stability, Woman
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nulliparous | Women who have never given birth | |
| Primiparous | Women who have given birth once | |
| Multiparous | Women who have given birth multiple times |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength/ maximal inspiratory pressure (MIP)
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.
Measured: On the day of enrollment
Respiratory Muscle Strength/maximal expiratory pressure (MEP)
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.
Measured: On the day of enrollment
Secondary outcomes (3)
Pressure Biofeedback Unite
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.
Measured: On the day of enrollment
Trunk Muscle Endurance Tests
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.
Measured: On the day of enrollment
Physical Activity Level
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.
Measured: On the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start14 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Muscle StrengthStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Istanbul Kültür University
- Responsible party
- Principal investigator, Imge NAS, Istanbul Kültür University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677346
- Sponsor's protocol ID
- İK-2023-02
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Parity and Respiratory Muscle Strength in Women.
- ClinicalTrials.gov ID
- NCT06677346
- Acronym / sponsor ID
- İK-2023-02
- Conditions
- Respiratory Muscle Strength, Parity, Core Stability, Woman
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Istanbul Kültür University
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Nov 2024 (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 aim of this study is to investigate the relationship between parity and respiratory muscle strength in women.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nulliparous | – | –Women who have never given birth |
| Primiparous | – | –Women who have given birth once |
| Multiparous | – | –Women who have given birth multiple times |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Being between 20-45 years old
- Being female
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Pressure Biofeedback Unite
Time frame: On the day of enrollment
Trunk Muscle Endurance Tests
Time frame: On the day of enrollment
Physical Activity Level
Time frame: On the day of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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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.
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 Respiratory Muscle Strength and Parity, run by Medipol University 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imge NAS (+902124984141, i.nas@iku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength/ maximal inspiratory pressure (MIP) (time frame: On the day of enrollment). The study lists 2 primary outcomes in all. 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 6 Nov 2024.