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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05246306
Other study ID # GO 21/947
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 22, 2021
Est. completion date September 21, 2022

Study information

Verified date October 2022
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Polycystic Ovary Syndrome (PCOS) is associated with hyperandrogenism, hyperinsulinemia and insulin resistance starting in the perimenarchal period. Insulin resistance also increases the risk of developing glucose intolerance, type 2 diabetes, hypertension, dyslipidemia and cardiovascular disorders. Studies on adult women with PCOS show that their aerobic capacity is affected. Therefore, in this study; it was aimed to compare the physical and cardiovascular fitness levels of adolescent PCOS patients with healthy adolescents.


Description:

Polycystic Ovary Syndrome (PCOS) is associated with hyperandrogenism, hyperinsulinemia and insulin resistance starting in the perimenarchal period. Insulin resistance also increases the risk of developing glucose intolerance, type 2 diabetes, hypertension, dyslipidemia and cardiovascular disorders. Studies on adult women with PCOS show that their aerobic capacity is affected. Therefore, in this study; it was aimed to compare the physical and cardiovascular fitness levels of adolescent PCOS patients with healthy adolescents.Total fat and muscle ratios will be measured with the bioelectrical impedance test (BIA) instrument for body composition evaluation of individuals in both groups. Body mass index (BMI), waist/hip and waist/height ratios will be recorded. The level of cardiovascular fitness will be evaluated with the PACER test, which is among the Fitness Gram Test Protocol. For physical fitness level, muscular strength parameter will be evaluated with hand dynamometer and knee extensor muscle strength, and muscular endurance parameter will be evaluated with sit-up and push-up tests. Participants' physical activities will be evaluated with the Adolescent Physical Activity Questionnaire (PAQ-A).The quality of life of individuals with PCOS will be evaluated with the Polycystic Ovary Syndrome Quality of Life-50 Scale.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date September 21, 2022
Est. primary completion date September 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 24 Years
Eligibility Inclusion Criteria of patients : - Being between the ages of 14-24, - Collecting Polycystic Syndrome according to Rotherdam, - Not having had Covid-19. Exclusion Criteria of the patients : - Not to be between the ages of 14-24, - Not showing the symptoms of Polycystic Ovary Syndrome (PCOS), - Having had Covid-19, - Having a chronic disease diagnosed other than PCOS, - Having cognitive impairment that will affect their cooperation with tests. Healthy group inclusion criteria - Being a female adolescent between the ages of 14-24, - Not having been diagnosed with any chronic disease, - Adolescents with regular menstrual cycles, - Not taking any medication known to affect hormone, lipid and carbohydrate metabolism, - Not having clinical signs of hyperandrogenism, - Not having had Covid-19. Healthy group exclusion criteria - Not to be between the ages of 14-24, - Having a chronic disease, - Having had Covid-19, - Having cognitive impairment that will affect their cooperation with tests.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (2)

Lead Sponsor Collaborator
Hacettepe University Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aerobic Exercise Capacity PACER running test, which is included in the fitnessgram test protocol, will be used to evaluate aerobic capacity. 1 day
Primary Physical Fitness The Fitnessgram Test Protocol will be used for physical fitness assessment. 1 day
Secondary Peripheral Muscle Strength With the Lafayette Manual Muscle Test System Model01165, knee extensor muscle strength will be measured in individuals in sitting position and knee extension. 3 repetitions will be applied for the right and left sides and the results will be recorded in kilograms. 1 day
Secondary Physical Activity Level Adolescent Physical Activity Questionnaire (PAQ-A) will be administered to both groups. This questionnaire is designed to assess physical activity in the last 7 days. It consists of 8 questions in which the answers given are scored between 1 and 5, and 9 questions questioning the existence of a situation that prevents physical activity in the last week. 1 day
Secondary Life quality The quality of life of individuals with Polycystic Ovary Syndrome will be evaluated with the Polycystic Ovary Syndrome Quality of Life-50 Scale. This scale consists of six parameters including psychosocial and status, fertility, sexual function, obesity and menstrual irregularity, hair growth and coping with the disease, and includes 50 questions. When calculating the total score and sub-dimension scores of the scale, it is scored as 5 never, rarely 4, sometimes 3, often 4, always 1. 1 day
Secondary Body composition analysis Body fat percentage (%), body muscle percentage (%), body water percentage (%), body fat weight (kg), body muscle weight (kg) will be recorded according to Bioelectrical Impedance Analysis. 1 day
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