Clinical trial NCT03068221: 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
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Overweight
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Peak anaerobic power
timeFrame: 30 seconds
measure: Mean anaerobic power
timeFrame: 30 seconds
Secondary outcomes:
measure: Total running time (Seconds) for a repeated sprint test.
timeFrame: between 40-120 seconds
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center , Tel Aviv University
Study officials:
affiliation: Meir Medical Center , Tel Aviv University
name: Alon Elikaim, MD
role: PRINCIPAL_INVESTIGATOR
References: