Clinical trial NCT05246306: Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Official title: Comparison of Aerobic Capacity and Physical Fitness Level of Adolescents With Polycystic Ovary Syndrome and Healthy Peers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: aerobic capacity
physical fitness
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Dr. Sami Ulus Children's Hospital
First posted: 2022-02-18
Enrollment: 44
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aerobic Exercise Capacity
timeFrame: 1 day
measure: Physical Fitness
timeFrame: 1 day
Secondary outcomes:
measure: Peripheral Muscle Strength
timeFrame: 1 day
measure: Physical Activity Level
timeFrame: 1 day
measure: Life quality
timeFrame: 1 day
measure: Body composition analysis
timeFrame: 1 day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ebru Calik Kutukcu, PhD
role: PRINCIPAL_INVESTIGATOR
References: