NCT05961241

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

July 18, 2023

Last Update Submit

February 17, 2024

Conditions

Urinary Stress Incontinence

Keywords

Urinary incontinencepelvic diaphragmwomen's health

Outcome Measures

Primary Outcomes (4)

  • direction of urinary bladder displacement during contraction

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

    baseline

  • urinary bladder displacement in millimeters

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

    baseline

  • pelvic floor muscles endurance of contraction in seconds

    time of muscle contraction will be measured during the last contraction

    baseline

  • urinary incontinence

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

    baseline

Study Arms (2)

running group

ACTIVE COMPARATOR

women who run on a regular basis

Other: runnin training program

control

EXPERIMENTAL

women who do not run

Other: runnin training program

Interventions

runnin training programOTHER

gradual training program

Also known as: running
controlrunning group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study examines pelvic floor function among women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haifa University, Department of PHysical Therapy

Haifa, Israel

Location

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence

Interventions

Running

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Gali Dar, Prof.

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD, senior lecturer

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 27, 2023

Study Start

January 1, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

IL(1)