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

October 14, 2023 updated by: Mai Mohamed Ali Shehata, Cairo University
The purpose of this study is to investigate the effect of whole body vibration on insulin resistance in females with polycystic ovarian syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

46

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

  • Egypt
      • Giza, Egypt
        • Faculty 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

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Females with polycystic ovarian syndrome.
  2. Their ages will range from 20 to 35 years.

Exclusion Criteria:

  • 1-Smoking. 2-History of chronic disease.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: whole body vibration
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
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
Device: Treadmill
Females will be asked to perform moderate intensity aerobic exercise for 45 minutes for 3 times per week for 8 weeks
Active Comparator: Aerboic exercise
Moderate intensity aerobic exercise in form of walking on treadmill for 3 times per week, 45 minutes per session for eight weeks
Device: Treadmill
Females will be asked to perform moderate intensity aerobic exercise for 45 minutes for 3 times per week for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homeostasis Model Assessment (HOMA-IR)
Time Frame: eight weeks
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
Time Frame: eight weeks
by a tape measurement around the waist
eight weeks
waist hip ratio
Time Frame: eight weeks
The formula = waist circumference / hip circumference.
eight weeks
LH/FSH ratio
Time Frame: Eight weeks
To assess the severity of PCOS
Eight weeks

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mai M Ali Shehata, lecturer, Faculty of Physical Therapy

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)

March 30, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 10, 2023

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003460

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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