Effect of Aerobic Exercise on Polycystic Ovary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-12-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Aerobic exercise group (AEM)

The AEM group performed aerobic exercise three times a week for 12 weeks in addition to Metformin treatment.

Group Type EXPERIMENTAL

Aerobic exercise in addition to Metformin treatment

Intervention Type OTHER

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.

Metformin group (M)

The M group received Metformin only

Group Type ACTIVE_COMPARATOR

Aerobic exercise in addition to Metformin treatment

Intervention Type OTHER

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.

Interventions

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Aerobic exercise in addition to Metformin treatment

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Disorders known to cause hyperandrogenisms, such as congenital adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia.
* Renal or hepatic dysfunction

Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No