Pelvic Floor Muscle Function Among Running Women

Study Overview
=================
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.

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.

Official Title
-----------------
Pelvic Floor Muscle Function Among Running Women

Conditions
-----------------
Urinary Stress Incontinence

Intervention / Treatment
-----------------
* Other: runnin training program


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: running group<br>women who run on a regular basis | Other: runnin training program<br>* gradual training program<br>* Other names: running;|
| Experimental: control<br>women who do not run | Other: runnin training program<br>* gradual training program<br>* Other names: running;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary incontinence, pelvic diaphragm, women's health