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

Primary Purpose

Polycystic Ovary Syndrome, Overweight

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
anaerobic exercise
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polycystic Ovary Syndrome

Eligibility Criteria

10 Years - 25 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Meir Medical Center , Tel Aviv University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Poly Cystic Ovary Syndrome

non Poly Cystic Ovary Syndrome

Arm Description

anaerobic exercise in overweight patients with PCOS

anaerobic exercise in overweight patients without PCOS

Outcomes

Primary Outcome Measures

Peak anaerobic power
The highest produced power (Watt/Kg) during cycling at maximal speed against a weight based calculated resistance for 30 seconds
Mean anaerobic power
The mean produced power (Watt/Kg) during cycling at maximal speed against a weight based calculated resistance for 30 seconds

Secondary Outcome Measures

Total running time (Seconds) for a repeated sprint test.
6 repetitions of 40 meter sprint, as fastest as the patient can run

Full Information

First Posted
February 12, 2017
Last Updated
December 9, 2019
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03068221
Brief Title
Clinical Sciences Research Proposal- The Effect of Physical Exercise on PCOS Overweight Female Adolescents
Official Title
Clinical Sciences Research Proposal- The Effect of Physical Exercise on Poly Cystic Ovary Syndrome Overweight Female Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Overweight

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Poly Cystic Ovary Syndrome
Arm Type
Active Comparator
Arm Description
anaerobic exercise in overweight patients with PCOS
Arm Title
non Poly Cystic Ovary Syndrome
Arm Type
Active Comparator
Arm Description
anaerobic exercise in overweight patients without PCOS
Intervention Type
Other
Intervention Name(s)
anaerobic exercise
Intervention Description
assessing anaerobic exercise status
Primary Outcome Measure Information:
Title
Peak anaerobic power
Description
The highest produced power (Watt/Kg) during cycling at maximal speed against a weight based calculated resistance for 30 seconds
Time Frame
30 seconds
Title
Mean anaerobic power
Description
The mean produced power (Watt/Kg) during cycling at maximal speed against a weight based calculated resistance for 30 seconds
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
Total running time (Seconds) for a repeated sprint test.
Description
6 repetitions of 40 meter sprint, as fastest as the patient can run
Time Frame
between 40-120 seconds

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alon Elikaim, MD
Organizational Affiliation
Meir Medical Center , Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center , Tel Aviv University
City
Kfar Saba
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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

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