Pelvic Floor Muscle Function Among Running Women

February 17, 2024 updated by: Gali Dar, University of Haifa
This study will examine pelvic floor muscles function amongst women who run on a regular basis compared to controls. Women who do not run, will begin running protocol, and second evaluation will be performed following 2 months of training. Urinary incontinence will also be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will include women who have been running on a regular basis over two years, at least 3 times a week for half an hour (research group) and women who do not run at all (control group). The participants will answer a personal information questionnaire (including birth and exercise background), and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). Outcome measures will include an evaluation of the PFM function using Vaginal palpation and abdominal ultrasound examination.

Women who do not run at all, will begin running training protocol, and second evaluation will be performed following 2 months of training.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Israel
      • Haifa, Israel
        • Haifa University, Department of PHysical Therapy

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

Description

Inclusion Criteria:

  • at least six months after giving birth or who have not given birth at all, The running group will recruit healthy women who run at least 3 times a week, 30 minutes, for two consecutive years.

The control group will recruit healthy women who do not physical active on a daily basis

Exclusion Criteria:

  • pregnancy
  • grade 3 or higher of pelvic organ prolapse.

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: running group
women who run on a regular basis
Other: runnin training program
gradual training program
Other Names:
  • running
Experimental: control
women who do not run
Other: runnin training program
gradual training program
Other Names:
  • running

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
direction of urinary bladder displacement during contraction
Time Frame: baseline
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
baseline
urinary bladder displacement in millimeters
Time Frame: baseline
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
baseline
pelvic floor muscles endurance of contraction in seconds
Time Frame: baseline
time of muscle contraction will be measured during the last contraction
baseline
urinary incontinence
Time Frame: baseline
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).
baseline

Collaborators and Investigators

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

Sponsor

University of Haifa

Investigators

  • Principal Investigator: Gali Dar, Prof., University of Haifa

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)

January 1, 2023

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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