Polycystic Ovarian SyndromeWBVNCT05215223
Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome
A study testing whole body vibration and Treadmill in people with Polycystic Ovarian Syndrome and Insulin Resistance, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome, Insulin Resistance
- What is being tested?
- whole body vibration and Treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2022to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with polycystic ovarian syndrome.
- Their ages will range from 20 to 35 years.
Who cannot join
- 1-Smoking. 2-History of chronic disease.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effect of whole body vibration on insulin resistance in females with polycystic ovarian syndrome
Read the 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
- Conditions
- Polycystic Ovarian Syndrome, Insulin Resistance
- Being tested
- whole body vibration, Treadmill
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
TreadmillDevice
Females will be asked to perform moderate intensity aerobic exercise for 45 minutes for 3 times per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: whole body vibration; Device: 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 Receives: Device: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: eight weeks
Secondary outcomes (3)
Waist circumference
by a tape measurement around the waist
Measured: eight weeks
waist hip ratio
The formula = waist circumference / hip circumference.
Measured: eight weeks
LH/FSH ratio
To assess the severity of PCOS
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start30 Mar 2022
- Primary completion1 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed Ali Shehata, Cairo University
- Investigators
- Mai M Ali Shehata, lecturer, Principal investigator, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215223
- Sponsor's protocol ID
- P.T.REC/012/003460
- Acronym
- WBV
- Status last verified
- Oct 2023
- First submitted
- 18 Jan 2022
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT05215223
- Acronym / sponsor ID
- WBV / P.T.REC/012/003460
- Conditions
- Polycystic Ovarian Syndrome, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole body vibration | Experimental | Device: whole body vibration, Device: Treadmillthe 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 |
| Aerboic exercise | Active comparator | Device: TreadmillModerate intensity aerobic exercise in form of walking on treadmill for 3 times per week, 45 minutes per session for eight weeks |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females with polycystic ovarian syndrome.
- Their ages will range from 20 to 35 years.
Key exclusion criteria (1 listed)
- 1-Smoking. 2-History of chronic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body vibrationthe 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 | whole body vibration |
| TreadmillFemales will be asked to perform moderate intensity aerobic exercise for 45 minutes for 3 times per week for 8 weeks | Device | Aerboic exercise, whole body vibration |
Primary outcome
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.
3 secondary outcomes
Waist circumference
Time frame: eight weeks
waist hip ratio
Time frame: eight weeks
LH/FSH ratio
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
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Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai M Ali Shehata, lecturer principal investigator
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration and Treadmill in people with Polycystic Ovarian Syndrome and Insulin Resistance, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostasis Model Assessment (HOMA-IR) (time frame: eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.