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Pelvic Floor Muscle Function Among Running Women

Sponsor
University of Haifa (Other)
Overall Status
Recruiting
CT.gov ID
NCT05961241
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: runnin training program
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups.Two groups.
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Pelvic Floor Muscle Function Among Running Women
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. direction of urinary bladder displacement during contraction [baseline]

      upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound

    2. urinary bladder displacement in millimeters [baseline]

      bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

    3. pelvic floor muscles endurance of contraction in seconds [baseline]

      time of muscle contraction will be measured during the last contraction

    4. urinary incontinence [baseline]

      International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haifa University, Department of PHysical Therapy Haifa Israel

    Sponsors and Collaborators

    • University of Haifa

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gali Dar, PHD, senior lecturer, University of Haifa
    ClinicalTrials.gov Identifier:
    NCT05961241
    Other Study ID Numbers:
    • 170/22
    First Posted:
    Jul 27, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gali Dar, PHD, senior lecturer, University of Haifa
    Urinary incontinence
    pelvic diaphragm
    women's health
    Additional relevant MeSH terms:
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Jul 27, 2023