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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05215223

Collaborator

(none)

Enrollment

Location

Arms

3.4

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovarian Syndrome Insulin Resistance	Device: whole body vibration Device: Treadmill	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 10, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Homeostasis Model Assessment (HOMA-IR) [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.

Secondary Outcome Measures

Waist circumference [eight weeks]
by a tape measurement around the waist
waist hip ratio [eight weeks]
The formula = waist circumference / hip circumference.
LH/FSH ratio [Eight weeks]
To assess the severity of PCOS

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of physical therapy	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Mai M Ali Shehata, lecturer, Faculty of physical therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mai Mohamed Ali Shehata, Lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT05215223

Other Study ID Numbers:

P.T.REC/012/003460

First Posted:

Jan 31, 2022

Last Update Posted:

May 23, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Insulin Resistance

Syndrome

Study Results

No Results Posted as of May 23, 2022