- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05246306
Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
October 9, 2022 updated by: Ebru Calik Kutukcu, Hacettepe University
Comparison of Aerobic Capacity and Physical Fitness Level of Adolescents With Polycystic Ovary Syndrome and Healthy Peers
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey, 06100
- Hacettepe University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Healthy group: Being in the adolescent group, not having any chronic disease and being willing to participate in the study.
Patient group: Being in the adolescent group, being diagnosed with polycystic ovary syndrome and being willing to participate in the study
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Healthy group
Healthy adolescents aged 14-24 who have not been diagnosed with any chronic disease
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Patient with PCOS group
Adolescents between the ages of 14-24 diagnosed with Polycystic Ovary Syndrome according to the Rotherdam criteria.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic Exercise Capacity
Time Frame: 1 day
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PACER running test, which is included in the fitnessgram test protocol, will be used to evaluate aerobic capacity.
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1 day
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Physical Fitness
Time Frame: 1 day
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The Fitnessgram Test Protocol will be used for physical fitness assessment.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripheral Muscle Strength
Time Frame: 1 day
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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.
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1 day
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Physical Activity Level
Time Frame: 1 day
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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.
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1 day
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Life quality
Time Frame: 1 day
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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.
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1 day
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Body composition analysis
Time Frame: 1 day
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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.
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ebru Calik Kutukcu, PhD, Hacettepe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2021
Primary Completion (Actual)
September 21, 2022
Study Completion (Actual)
September 21, 2022
Study Registration Dates
First Submitted
January 21, 2022
First Submitted That Met QC Criteria
February 17, 2022
First Posted (Actual)
February 18, 2022
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 9, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 21/947
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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