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

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ClinicalTrials.gov Identifier: NCT03068221
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Overweight Other: anaerobic exercise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Sciences Research Proposal- The Effect of Physical Exercise on Poly Cystic Ovary Syndrome Overweight Female Adolescents
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Poly Cystic Ovary Syndrome
anaerobic exercise in overweight patients with PCOS
Other: anaerobic exercise
assessing anaerobic exercise status

Active Comparator: non Poly Cystic Ovary Syndrome
anaerobic exercise in overweight patients without PCOS
Other: anaerobic exercise
assessing anaerobic exercise status




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068221


Locations
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Israel
Meir Medical Center , Tel Aviv University Recruiting
Kfar Saba, Israel
Contact: Michal Pantanowitz, PhD    972-9-7471596    michalmorochnik@gmail.com   
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Alon Elikaim, MD Meir Medical Center , Tel Aviv University

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT03068221     History of Changes
Other Study ID Numbers: 0342-16CTIL
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Overweight
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases