NCT05215223

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

January 18, 2022

Last Update Submit

October 14, 2023

Conditions

Polycystic Ovarian SyndromeInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Waist circumference

    eight weeks

  • waist hip ratio

    eight weeks

  • LH/FSH ratio

    Eight weeks

Study Arms (2)

whole body vibration

EXPERIMENTAL

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 vibrationDevice: Treadmill

Aerboic exercise

ACTIVE COMPARATOR

Moderate intensity aerobic exercise in form of walking on treadmill for 3 times per week, 45 minutes per session for eight weeks

Device: Treadmill

Interventions

whole body vibrationDEVICE

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

whole body vibration
TreadmillDEVICE

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

Aerboic exercisewhole body vibration

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Smoking. 2-History of chronic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Mai M Ali Shehata, lecturer

    faculty of physical therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

March 30, 2022

Primary Completion

October 1, 2023

Study Completion

October 10, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

EG(1)