- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03068221
Clinical Sciences Research Proposal- The Effect of Physical Exercise on PCOS Overweight Female Adolescents
Clinical Sciences Research Proposal- The Effect of Physical Exercise on Poly Cystic Ovary Syndrome Overweight Female Adolescents
The Poly Cystic Ovary Syndrome (PCOS), is one of the most common reasons for subfertility, oligomenorrhea and amenorrhea. With the occurrence of 6-20% of the general adult women population. One of the main criteria of this syndrome is a hyper androgenic state.
More than 50% of women who have PCOS are overweight. In the teenage population, PCOS is common in 5-10% of teenage girls. A recent research has shown that elite athlete teenage girls have higher serum androgen levels, especially in anaerobic types of sport.
The purpose of this experiment is to examine the reaction of teenage PCOS overweight girls towards anaerobic exercise. To determine if their hyperandrogenic state is more adapted to excel in anaerobic exercise compared to teenage overweight girls without PCOS.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
30 teenage and young adult females, aged 10-25 years old. The minimum hormonal age for inclusion is menarche. Overweight- with a Body Mass Index (BMI) percentage above 85%, divided into 2 groups: 15 girls with diagnosed PCOS, and 15 girls without diagnosed PCOS, without any other medical comorbidities. Followed at the pediatric endocrinology unit.
The 2 groups would participate in 2 anaerobic tests to evaluate their performances. The data received will be used to evaluate their anaerobic attributes, and for comparison between the 2 groups to determine any differences.
The participants will be asked to refrain from any form of physical exercise during the previous day.
After explanation to the patient and his parent and obtaining an informed consent, the participants will start the tests.
The first test is the Repeated Sprint Test: The participant will run a distance of 40 meters, for 6 repetitions. The optimal running time will be calculated, total running time and the Performance Decrement of the run will be calculated.
After that, there will be a 1-1.5 hours resting phase. The second test is the "Wingate Test"- the participants will be instructed to pedal at a maximal pace for 30 seconds on an ergometric bicycle against a resistance adjusted according to their BMI. The Peak Anaerobic Power, the Mean Anaerobic Power and the Fatigue Index will be calculated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kfar Saba, Israel
- Meir Medical Center , Tel Aviv University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- post menarche female
- PCOS diagnosis
- overweight- BMI above 85 percent.
Exclusion Criteria:
- inability to complete the physical activity due to health issues
- Thyroid dysfunction (hyper-, hypo-)
- hyperprolactinemia
- congenital adrenal hyperplasia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Poly Cystic Ovary Syndrome
anaerobic exercise in overweight patients with PCOS
|
assessing anaerobic exercise status
|
Active Comparator: non Poly Cystic Ovary Syndrome
anaerobic exercise in overweight patients without PCOS
|
assessing anaerobic exercise status
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak anaerobic power
Time Frame: 30 seconds
|
The highest produced power (Watt/Kg) during cycling at maximal speed against a weight based calculated resistance for 30 seconds
|
30 seconds
|
Mean anaerobic power
Time Frame: 30 seconds
|
The mean produced power (Watt/Kg) during cycling at maximal speed against a weight based calculated resistance for 30 seconds
|
30 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total running time (Seconds) for a repeated sprint test.
Time Frame: between 40-120 seconds
|
6 repetitions of 40 meter sprint, as fastest as the patient can run
|
between 40-120 seconds
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alon Elikaim, MD, Meir Medical Center , Tel Aviv University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0342-16CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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