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

Sponsor

Meir Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03068221

Collaborator

(none)

Enrollment

Location

Arms

31.5

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Overweight	Other: anaerobic exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 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 :

Mar 15, 2017

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Oct 30, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Total running time (Seconds) for a repeated sprint test. [between 40-120 seconds]
6 repetitions of 40 meter sprint, as fastest as the patient can run

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical Center , Tel Aviv University	Kfar Saba		Israel

Sponsors and Collaborators

Meir Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT03068221

Other Study ID Numbers:

0342-16CTIL

First Posted:

Mar 1, 2017

Last Update Posted:

Dec 11, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Overweight

Study Results

No Results Posted as of Dec 11, 2019