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

Overweight Clinical Trial

Official title:

Clinical Sciences Research Proposal- The Effect of Physical Exercise on Poly Cystic Ovary Syndrome Overweight Female Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068221
• Other study ID #: 0342-16CTIL
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: December 2019
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• anaerobic exercise
assessing anaerobic exercise status

Locations

Country	Name	City	State
Israel	Meir Medical Center , Tel Aviv University	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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