Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246306
• Other study ID #: GO 21/947
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

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