NCT06677346

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 14, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

November 4, 2024

Last Update Submit

November 5, 2024

Conditions

Respiratory Muscle StrengthParityCore StabilityWoman

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    On the day of enrollment

Secondary Outcomes (3)

  • Pressure Biofeedback Unite

    On the day of enrollment

  • Trunk Muscle Endurance Tests

    On the day of enrollment

  • Physical Activity Level

    On the day of enrollment

Study Arms (3)

Nulliparous

Women who have never given birth

Primiparous

Women who have given birth once

Multiparous

Women who have given birth multiple times

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Being between 20-45 years old
  • Being female

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Kultur University

Istanbul, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Imge NAS

CONTACT

+902124984141i.nas@iku.edu.tr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 6, 2024

Study Start

June 14, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)