Polycystic Ovary SyndromeNCT05233514
Effect of Aerobic Exercise on Polycystic Ovary Syndrome
A study testing Aerobic exercise in addition to Metformin treatment in people with Polycystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The development of Polycystic Ovary Syndrome has been linked to chronic low-grade inflammation (PCOS). In this context, the current study looked into the effects of aerobic exercise on IL6, TNF, and C-reactive protein (CRP) in PCOS women. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Aerobic exercise in addition to Metformin treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 10 Dec 2021
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mean age of 26.7 ± 2.3, body mass index (BMI) 23.6±3.5 kg/m2) .
- confirmation by medical history of hyperandrogenic oligo amenorrhea (<8 menses per year)
- PCO on ultrasonography of more than 10 ovarian follicles 2-9 mm in diameter
Who cannot join
- Disorders known to cause hyperandrogenisms, such as congenital adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia.
- Renal or hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aerobic Exercise on Inflammatory Markers in Polycystic Ovary Syndrome
The development of Polycystic Ovary Syndrome has been linked to chronic low-grade inflammation (PCOS). In this context, the current study looked into the effects of aerobic exercise on IL6, TNF, and C-reactive protein (CRP) in PCOS women. This was a randomized clinical trial including 40 females diagnosed with PCOS who were between the ages of 25 and 35. The participants were divided into two groups, each with an equal number of individuals: aerobic exercise (AEM) and Metformin (M). At baseline and after 12 weeks of intervention, participants' levels of IL6, TNF, and CRP were measured.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Aerobic exercise in addition to Metformin treatment
- 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.
Aerobic exercise in addition to Metformin treatmentOther
The aerobic exercises were walking on the treadmill for 30 minutes at a 0% slope, including three phases: the warming-up phase, which consisted of walking on the treadmill for five minutes at low intensity (30% of Maximum Heart Rate, MHR), the actual phase, which consisted of walking on the treadmill for 20 min at moderate intensity (60 -70% of MHR) and the cooling phase, which consisted of walking on the treadmill for five minutes at low intensity (30% of MHR). The MHR was calculated according to the equation (210- age in years). Both the AEM and M groups received metformin 1,500 mg daily for a further 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise group (AEM) | Experimental | The AEM group performed aerobic exercise three times a week for 12 weeks in addition to Metformin treatment. Receives: Other: Aerobic exercise in addition to Metformin treatment |
| Metformin group (M) | Active comparator | The M group received Metformin only Receives: Other: Aerobic exercise in addition to Metformin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Interleukin 6
Measured: 12 weeks
Level of TNF-α
Measured: 12 weeks
level of C- reactive protein
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Apr 2020
- Primary completion1 Oct 2021
- Study completion10 Dec 2021
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 Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants were divided into two groups equal in number: the aerobic exercise group (AEM), and the Metformin group (M). The AEM group performed aerobic exercise three times a week for 12 weeks in addition to Metformin treatment. The M group received Metformin only
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233514
- Sponsor's protocol ID
- POV
- Status last verified
- Feb 2022
- First submitted
- 29 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- 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 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise on Inflammatory Markers in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05233514
- Acronym / sponsor ID
- POV
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 10 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.
The development of Polycystic Ovary Syndrome has been linked to chronic low-grade inflammation (PCOS). In this context, the current study looked into the effects of aerobic exercise on IL6, TNF, and C-reactive protein (CRP) in PCOS women. This was a randomized clinical trial including 40 females diagnosed with PCOS who were between the ages of 25 and 35. The participants were divided into two groups, each with an equal number of individuals: aerobic exercise (AEM) and Metformin (M). At baseline and after 12 weeks of intervention, participants' levels of IL6, TNF, and CRP were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- participants were divided into two groups equal in number: the aerobic exercise group (AEM), and the Metformin group (M). The AEM group performed aerobic exercise three times a week for 12 weeks in addition to Metformin treatment. The M group received Metformin only
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise group (AEM) | Experimental | Other: Aerobic exercise in addition to Metformin treatmentThe AEM group performed aerobic exercise three times a week for 12 weeks in addition to Metformin treatment. |
| Metformin group (M) | Active comparator | Other: Aerobic exercise in addition to Metformin treatmentThe M group received Metformin only |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mean age of 26.7 ± 2.3, body mass index (BMI) 23.6±3.5 kg/m2) .
- confirmation by medical history of hyperandrogenic oligo amenorrhea (<8 menses per year)
- PCO on ultrasonography of more than 10 ovarian follicles 2-9 mm in diameter
Key exclusion criteria (2 listed)
- Disorders known to cause hyperandrogenisms, such as congenital adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia.
- Renal or hepatic dysfunction
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 |
|---|---|---|
| Aerobic exercise in addition to Metformin treatmentThe aerobic exercises were walking on the treadmill for 30 minutes at a 0% slope, including three phases: the warming-up phase, which consisted of walking on the treadmill for five minutes at low intensity (30% of Maximum Heart Rate, MHR), the actual phase, which consisted of walking on the treadmill for 20 min at moderate intensity (60 -70% of MHR) and the cooling phase, which consisted of walking on the treadmill for five minutes at low intensity (30% of MHR). The MHR was calculated according to the equation (210- age in years). Both the AEM and M groups received metformin 1,500 mg daily for a further 12 weeks. | Other | Aerobic exercise group (AEM), Metformin group (M) |
Primary outcome
Level of Interleukin 6
Time frame: 12 weeks
Level of TNF-α
Time frame: 12 weeks
level of C- reactive protein
Time frame: 12 weeks
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 10 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in addition to Metformin treatment in people with Polycystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.
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 2 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 10 Feb 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 Egypt. 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?
Level of Interleukin 6 (time frame: 12 weeks). The study lists 3 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 10 Feb 2022.