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Completed

NCT Number: NCT05246306

Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Aerobic Exercise Capacity

    Time frame: 1 day

    PACER running test, which is included in the fitnessgram test protocol, will be used to evaluate aerobic capacity.

  2. Physical Fitness

    Time frame: 1 day

    The Fitnessgram Test Protocol will be used for physical fitness assessment.

Secondary outcomes

  1. Peripheral Muscle Strength

    Time frame: 1 day

    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.

  2. Physical Activity Level

    Time frame: 1 day

    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.

  3. Life quality

    Time frame: 1 day

    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.

  4. Body composition analysis

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Dr. Sami Ulus Children's Hospital

Registry information

Official study title

Comparison of Aerobic Capacity and Physical Fitness Level of Adolescents With Polycystic Ovary Syndrome and Healthy Peers

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2022
Registry last updated
Oct 12, 2022

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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