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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05215223
Other study ID # P.T.REC/012/003460
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2022
Est. completion date October 10, 2023

Study information

Verified date October 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of whole body vibration on insulin resistance in females with polycystic ovarian syndrome


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


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date October 10, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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 Design


Intervention

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
Treadmill
Females will be asked to perform moderate intensity aerobic exercise for 45 minutes for 3 times per week for 8 weeks

Locations

Country Name City State
Egypt Faculty of physical therapy Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Waist circumference by a tape measurement around the waist eight weeks
Secondary waist hip ratio The formula = waist circumference / hip circumference. eight weeks
Secondary LH/FSH ratio To assess the severity of PCOS Eight weeks
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