Back to resultsEffect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome (WBV)
Primary Purpose
Polycystic Ovarian Syndrome, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
whole body vibration
Treadmill
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovarian Syndrome
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.
Sites / Locations
- Faculty of physical therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
whole body vibration
Aerboic exercise
Arm Description
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
Moderate intensity aerobic exercise in form of walking on treadmill for 3 times per week, 45 minutes per session for eight weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Waist circumference
by a tape measurement around the waist
waist hip ratio
The formula = waist circumference / hip circumference.
LH/FSH ratio
To assess the severity of PCOS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05215223
Brief Title
Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome
Acronym
WBV
Official Title
Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Actual)
Study Completion Date
October 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome, Insulin Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
whole body vibration
Arm Type
Experimental
Arm Description
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
Arm Title
Aerboic exercise
Arm Type
Active Comparator
Arm Description
Moderate intensity aerobic exercise in form of walking on treadmill for 3 times per week, 45 minutes per session for eight weeks
Intervention Type
Device
Intervention Name(s)
whole body vibration
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Treadmill
Intervention Description
Females will be asked to perform moderate intensity aerobic exercise for 45 minutes for 3 times per week for 8 weeks
Primary Outcome Measure Information:
Title
Homeostasis Model Assessment (HOMA-IR)
Description
Estimate insulin resistance (IR), it will be calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
Waist circumference
Description
by a tape measurement around the waist
Time Frame
eight weeks
Title
waist hip ratio
Description
The formula = waist circumference / hip circumference.
Time Frame
eight weeks
Title
LH/FSH ratio
Description
To assess the severity of PCOS
Time Frame
Eight weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai M Ali Shehata, lecturer
Organizational Affiliation
faculty of physical therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy
City
Giza
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome
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