Polycystic Ovary SyndromeNCT05246306
Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
An observational study of Polycystic Ovary Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 14 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2021to 21 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Being between the ages of 14-24,
- Collecting Polycystic Syndrome according to Rotherdam,
- Not having had Covid-19.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- aerobic capacity, physical fitness
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Exercise Capacity
PACER running test, which is included in the fitnessgram test protocol, will be used to evaluate aerobic capacity.
Measured: 1 day
Physical Fitness
The Fitnessgram Test Protocol will be used for physical fitness assessment.
Measured: 1 day
Secondary outcomes (4)
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start22 Sep 2021
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Sami Ulus Children's Hospital
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Ebru Calik Kutukcu, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246306
- Sponsor's protocol ID
- GO 21/947
- Status last verified
- Oct 2022
- First submitted
- 21 Jan 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aerobic Capacity and Physical Fitness Level of Adolescents With Polycystic Ovary Syndrome and Healthy Peers
- ClinicalTrials.gov ID
- NCT05246306
- Acronym / sponsor ID
- GO 21/947
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- aerobic capacity, physical fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Dr. Sami Ulus Children's Hospital
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- Being between the ages of 14-24,
- Collecting Polycystic Syndrome according to Rotherdam,
- Not having had Covid-19.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Physical Fitness
Time frame: 1 day
The Fitnessgram Test Protocol will be used for physical fitness assessment.
4 secondary outcomes
Peripheral Muscle Strength
Time frame: 1 day
Physical Activity Level
Time frame: 1 day
Life quality
Time frame: 1 day
Body composition analysis
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Calik Kutukcu, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Exercise Capacity (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.