Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05246306
Collaborator
Dr. Sami Ulus Children's Hospital (Other)
40
1
12
3.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Comparison of Aerobic Capacity and Physical Fitness Level of Adolescents With Polycystic Ovary Syndrome and Healthy Peers
    Actual Study Start Date :
    Sep 22, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 21, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy group

    Healthy adolescents aged 14-24 who have not been diagnosed with any chronic disease

    Patient with PCOS group

    Adolescents between the ages of 14-24 diagnosed with Polycystic Ovary Syndrome according to the Rotherdam criteria.

    Outcome Measures

    Primary Outcome Measures

    1. Aerobic Exercise Capacity [1 day]

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

    2. Physical Fitness [1 day]

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

    Secondary Outcome Measures

    1. Peripheral Muscle Strength [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 24 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University Ankara Turkey 06100

    Sponsors and Collaborators

    • Hacettepe University
    • Dr. Sami Ulus Children's Hospital

    Investigators

    • Principal Investigator: Ebru Calik Kutukcu, PhD, Hacettepe University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ebru Calik Kutukcu, Associate Professor, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT05246306
    Other Study ID Numbers:
    • GO 21/947
    First Posted:
    Feb 18, 2022
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ebru Calik Kutukcu, Associate Professor, Hacettepe University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022