Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of whole body vibration on insulin resistance in females with polycystic ovarian syndrome

Detailed Description
-----------------
polycystic ovarian syndrome is a complex endocrine condition characterized by metabolic abnormalities such as insulin resistance, excess weight or obesity, diabetes, and an increased risk of cardiovascular disease.Despite previous studies reported that physical exercise improves insulin resistance in females with polycystic ovarian syndrome, there is no study yet investigate the effect of whole body vibration on insulin resistance

Official Title
-----------------
Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome

Conditions
-----------------
Polycystic Ovarian Syndrome, Insulin Resistance

Intervention / Treatment
-----------------
* Device: whole body vibration
* Device: Treadmill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females with polycystic ovarian syndrome. Their ages will range from 20 to 35 years. Exclusion Criteria: 1-Smoking. 2-History of chronic disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whole body vibration<br>the patient will be received whole body vibration for three times/ week in addition to aerobic exercise for 3 times per week, 45 minutes per session for eight weeks | Device: whole body vibration<br>* the patients will stand on whole body vibration device with maintaining squatting position while keeping their trunk extended. The first training session will be consisted of three sets of 1 min and will be separated by a 1-min of standing rest. intensity will 1 mm. Then one set will be added every session<br>Device: Treadmill<br>* Females will be asked to perform moderate intensity aerobic exercise for 45 minutes for 3 times per week for 8 weeks<br>|
| Active Comparator: Aerboic exercise<br>Moderate intensity aerobic exercise in form of walking on treadmill for 3 times per week, 45 minutes per session for eight weeks | Device: Treadmill<br>* Females will be asked to perform moderate intensity aerobic exercise for 45 minutes for 3 times per week for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostasis Model Assessment (HOMA-IR) | Estimate insulin resistance (IR), it will be calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | by a tape measurement around the waist | eight weeks | 
| waist hip ratio | The formula = waist circumference / hip circumference. | eight weeks | 
| LH/FSH ratio | To assess the severity of PCOS | Eight weeks |