Effect of Aerobic Exercise on Polycystic Ovary Syndrome

NCT05233514 | Completed

• 1 other identifier: POV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

• Level of Interleukin 6

  12 weeks

• Level of TNF-α

  12 weeks

• level of C- reactive protein

  12 weeks

Study Arms (2)

Aerobic exercise group (AEM)

EXPERIMENTAL

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

Metformin group (M)

ACTIVE COMPARATOR

The M group received Metformin only

Other: Aerobic exercise in addition to Metformin treatment

Interventions

Aerobic exercise in addition to Metformin treatment 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.

Aerobic exercise group (AEM); Metformin group (M)

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of physical therapy for surgery

Model Details: 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

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 10, 2022
• Study Start: April 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 10, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)