Effect of Aerobic Exercise on Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effect of Aerobic Exercise on Inflammatory Markers in Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05233514
• Other study ID #: POV
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: December 10, 2021

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 10, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Egypt	Marwa Eid	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Interleukin 6		12 weeks
Primary	Level of TNF-a		12 weeks
Primary	level of C- reactive protein		12 weeks