Effect of Aerobic Exercise on Polycystic Ovary Syndrome

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT05233514

Collaborator

(none)

Enrollment

Location

Arms

20.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Other: Aerobic exercise in addition to Metformin treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 onlyparticipants 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 (Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Aerobic Exercise on Inflammatory Markers in Polycystic Ovary Syndrome

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Dec 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aerobic exercise group (AEM) The AEM group performed aerobic exercise three times a week for 12 weeks in addition to Metformin treatment.	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.
Active Comparator: Metformin group (M) The M group received Metformin only	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.

Arm

Intervention/Treatment

Experimental: Aerobic exercise group (AEM)

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

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.

Active Comparator: Metformin group (M)

The M group received Metformin only

Other: Aerobic exercise in addition to Metformin treatment

Outcome Measures

Primary Outcome Measures

Level of Interleukin 6 [12 weeks]
Level of TNF-α [12 weeks]
level of C- reactive protein [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marwa Eid	Cairo		Egypt	2011

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwa Eid, Professor of physical therapy for surgery, Cairo University

ClinicalTrials.gov Identifier:

NCT05233514

Other Study ID Numbers:

First Posted:

Feb 10, 2022

Last Update Posted:

Feb 10, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Metformin

Study Results

No Results Posted as of Feb 10, 2022