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: Completed
• Conditions: Polycystic Ovary Syndrome; Overweight
• Intervention / Treatment: Other: anaerobic exercise

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medical Center , Tel Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

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)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak anaerobic power	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	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.	6 repetitions of 40 meter sprint, as fastest as the patient can run	between 40-120 seconds

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Alon Elikaim, MD, Meir Medical Center , Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: February 12, 2017
• First Submitted That Met QC Criteria: February 26, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Body Weight; Polycystic Ovary Syndrome; Syndrome; Overweight
• Other Study ID Numbers: 0342-16CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No