Clinical Sciences Research Proposal- The Effect of Physical Exercise on PCOS Overweight Female Adolescents
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedStudy Start
First participant enrolled
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedDecember 11, 2019
December 1, 2019
2.5 years
February 12, 2017
December 9, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Total running time (Seconds) for a repeated sprint test.
between 40-120 seconds
Study Arms (2)
Poly Cystic Ovary Syndrome
ACTIVE COMPARATORanaerobic exercise in overweight patients with PCOS
non Poly Cystic Ovary Syndrome
ACTIVE COMPARATORanaerobic exercise in overweight patients without PCOS
Interventions
assessing anaerobic exercise status
Eligibility Criteria
You may qualify if:
- post menarche female
- PCOS diagnosis
- overweight- BMI above 85 percent.
You may not qualify if:
- inability to complete the physical activity due to health issues
- Thyroid dysfunction (hyper-, hypo-)
- hyperprolactinemia
- congenital adrenal hyperplasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir Medical Center , Tel Aviv University
Kfar Saba, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alon Elikaim, MD
Meir Medical Center , Tel Aviv University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2017
First Posted
March 1, 2017
Study Start
March 15, 2017
Primary Completion
September 30, 2019
Study Completion
October 30, 2019
Last Updated
December 11, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share