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Clinical Sciences Research Proposal- The Effect of Physical Exercise on PCOS Overweight Female Adolescents

NCT ID: NCT03068221

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2019-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome Overweight

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Poly Cystic Ovary Syndrome

anaerobic exercise in overweight patients with PCOS

Group Type ACTIVE_COMPARATOR

anaerobic exercise

Intervention Type OTHER

assessing anaerobic exercise status

non Poly Cystic Ovary Syndrome

anaerobic exercise in overweight patients without PCOS

Group Type ACTIVE_COMPARATOR

anaerobic exercise

Intervention Type OTHER

assessing anaerobic exercise status

Interventions

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anaerobic exercise

assessing anaerobic exercise status

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alon Elikaim, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center , Tel Aviv University

Locations

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Meir Medical Center , Tel Aviv University

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0342-16CTIL

Identifier Type: -

Identifier Source: org_study_id