Polycystic Ovary SyndromeNCT03068221
Clinical Sciences Research Proposal- The Effect of Physical Exercise on PCOS Overweight Female Adolescents
A study testing anaerobic exercise in people with Polycystic Ovary Syndrome and Overweight, run by Meir Medical Center at 1 site in Israel.
Trial summary
The Poly Cystic Ovary Syndrome (PCOS), is one of the most common reasons for subfertility, oligomenorrhea and amenorrhea. With the occurrence of 6-20% of the general adult women population. One of the main criteria of this syndrome is a hyper androgenic state. More than 50% of women who have PCOS are overweight. Read more about this study
- Who is it for?
- Ages 10 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Overweight
- What is being tested?
- anaerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Mar 2017to 30 Oct 2019
- Phase
- Interventional
- 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 10 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- post menarche female
- PCOS diagnosis
- overweight- BMI above 85 percent.
Who cannot join
- inability to complete the physical activity due to health issues
- Thyroid dysfunction (hyper-, hypo-)
- hyperprolactinemia
- congenital adrenal hyperplasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Sciences Research Proposal- The Effect of Physical Exercise on Poly Cystic Ovary Syndrome Overweight Female Adolescents
The Poly Cystic Ovary Syndrome (PCOS), is one of the most common reasons for subfertility, oligomenorrhea and amenorrhea. With the occurrence of 6-20% of the general adult women population. One of the main criteria of this syndrome is a hyper androgenic state.
More than 50% of women who have PCOS are overweight. In the teenage population, PCOS is common in 5-10% of teenage girls. A recent research has shown that elite athlete teenage girls have higher serum androgen levels, especially in anaerobic types of sport.
The purpose of this experiment is to examine the reaction of teenage PCOS overweight girls towards anaerobic exercise. To determine if their hyperandrogenic state is more adapted to excel in anaerobic exercise compared to teenage overweight girls without PCOS.
Read the detailed description
30 teenage and young adult females, aged 10-25 years old. The minimum hormonal age for inclusion is menarche. Overweight- with a Body Mass Index (BMI) percentage above 85%, divided into 2 groups: 15 girls with diagnosed PCOS, and 15 girls without diagnosed PCOS, without any other medical comorbidities. Followed at the pediatric endocrinology unit.
The 2 groups would participate in 2 anaerobic tests to evaluate their performances. The data received will be used to evaluate their anaerobic attributes, and for comparison between the 2 groups to determine any differences.
The participants will be asked to refrain from any form of physical exercise during the previous day.
After explanation to the patient and his parent and obtaining an informed consent, the participants will start the tests.
The first test is the Repeated Sprint Test: The participant will run a distance of 40 meters, for 6 repetitions. The optimal running time will be calculated, total running time and the Performance Decrement of the run will be calculated.
After that, there will be a 1-1.5 hours resting phase. The second test is the "Wingate Test"- the participants will be instructed to pedal at a maximal pace for 30 seconds on an ergometric bicycle against a resistance adjusted according to their BMI. The Peak Anaerobic Power, the Mean Anaerobic Power and the Fatigue Index will be calculated.
- Conditions
- Polycystic Ovary Syndrome, Overweight
- Being tested
- anaerobic exercise
- Medical subject headings
- Polycystic Ovary Syndrome, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anaerobic exerciseOther
assessing anaerobic exercise status
| Study group | Role | What they receive |
|---|---|---|
| Poly Cystic Ovary Syndrome | Active comparator | anaerobic exercise in overweight patients with PCOS Receives: Other: anaerobic exercise |
| non Poly Cystic Ovary Syndrome | Active comparator | anaerobic exercise in overweight patients without PCOS Receives: Other: anaerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak anaerobic power
The highest produced power (Watt/Kg) during cycling at maximal speed against a weight based calculated resistance for 30 seconds
Measured: 30 seconds
Mean anaerobic power
The mean produced power (Watt/Kg) during cycling at maximal speed against a weight based calculated resistance for 30 seconds
Measured: 30 seconds
Secondary outcomes (1)
Total running time (Seconds) for a repeated sprint test.
6 repetitions of 40 meter sprint, as fastest as the patient can run
Measured: between 40-120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start15 Mar 2017
- Primary completion30 Sep 2019
- Study completion30 Oct 2019
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alon Elikaim, MD, Principal investigator, Meir Medical Center , Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068221
- Sponsor's protocol ID
- 0342-16CTIL
- Status last verified
- Dec 2019
- First submitted
- 12 Feb 2017
- Last updated
- 11 Dec 2019
- 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 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Sciences Research Proposal- The Effect of Physical Exercise on Poly Cystic Ovary Syndrome Overweight Female Adolescents
- ClinicalTrials.gov ID
- NCT03068221
- Acronym / sponsor ID
- 0342-16CTIL
- Conditions
- Polycystic Ovary Syndrome, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 1 Mar 2017 (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.
The Poly Cystic Ovary Syndrome (PCOS), is one of the most common reasons for subfertility, oligomenorrhea and amenorrhea. With the occurrence of 6-20% of the general adult women population. One of the main criteria of this syndrome is a hyper androgenic state.
More than 50% of women who have PCOS are overweight. In the teenage population, PCOS is common in 5-10% of teenage girls. A recent research has shown that elite athlete teenage girls have higher serum androgen levels, especially in anaerobic types of sport.
The purpose of this experiment is to examine the reaction of teenage PCOS overweight girls towards anaerobic exercise. To determine if their hyperandrogenic state is more adapted to excel in anaerobic exercise compared to teenage overweight girls without PCOS.
Detailed description
30 teenage and young adult females, aged 10-25 years old. The minimum hormonal age for inclusion is menarche. Overweight- with a Body Mass Index (BMI) percentage above 85%, divided into 2 groups: 15 girls with diagnosed PCOS, and 15 girls without diagnosed PCOS, without any other medical comorbidities. Followed at the pediatric endocrinology unit.
The 2 groups would participate in 2 anaerobic tests to evaluate their performances. The data received will be used to evaluate their anaerobic attributes, and for comparison between the 2 groups to determine any differences.
The participants will be asked to refrain from any form of physical exercise during the previous day.
After explanation to the patient and his parent and obtaining an informed consent, the participants will start the tests.
The first test is the Repeated Sprint Test: The participant will run a distance of 40 meters, for 6 repetitions. The optimal running time will be calculated, total running time and the Performance Decrement of the run will be calculated.
After that, there will be a 1-1.5 hours resting phase. The second test is the "Wingate Test"- the participants will be instructed to pedal at a maximal pace for 30 seconds on an ergometric bicycle against a resistance adjusted according to their BMI. The Peak Anaerobic Power, the Mean Anaerobic Power and the Fatigue Index will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poly Cystic Ovary Syndrome | Active comparator | Other: anaerobic exerciseanaerobic exercise in overweight patients with PCOS |
| non Poly Cystic Ovary Syndrome | Active comparator | Other: anaerobic exerciseanaerobic exercise in overweight patients without PCOS |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- post menarche female
- PCOS diagnosis
- overweight- BMI above 85 percent.
Key exclusion criteria (4 listed)
- inability to complete the physical activity due to health issues
- Thyroid dysfunction (hyper-, hypo-)
- hyperprolactinemia
- congenital adrenal hyperplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anaerobic exerciseassessing anaerobic exercise status | Other | Poly Cystic Ovary Syndrome, non Poly Cystic Ovary Syndrome |
Primary outcome
Peak anaerobic power
Time frame: 30 seconds
The highest produced power (Watt/Kg) during cycling at maximal speed against a weight based calculated resistance for 30 seconds
Mean anaerobic power
Time frame: 30 seconds
The mean produced power (Watt/Kg) during cycling at maximal speed against a weight based calculated resistance for 30 seconds
1 secondary outcome
Total running time (Seconds) for a repeated sprint test.
Time frame: between 40-120 seconds
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 11 Dec 2019.
- Individual participant dataSharing planned: No
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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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.
Alon Elikaim, MD principal investigator
Meir Medical Center , Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anaerobic exercise in people with Polycystic Ovary Syndrome and Overweight, run by Meir Medical Center at 1 site in Israel.
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 4 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 11 Dec 2019. 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 Israel. 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?
Peak anaerobic power (time frame: 30 seconds). 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 11 Dec 2019.