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NCT Number: NCT03068221

Clinical Sciences Research Proposal- The Effect of Physical Exercise on PCOS 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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

10 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Meir Medical Center , Tel Aviv University

Kfar Saba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anaerobic exercise

Other

assessing anaerobic exercise status

Primary outcomes

  1. Peak anaerobic power

    Time frame: 30 seconds

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

  2. Mean anaerobic power

    Time frame: 30 seconds

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

Secondary outcomes

  1. Total running time (Seconds) for a repeated sprint test.

    Time frame: between 40-120 seconds

    6 repetitions of 40 meter sprint, as fastest as the patient can run

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2017
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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