Back to resultsEffect of Aerobic Exercise on Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic exercise in addition to Metformin treatment
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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
Sites / Locations
- Marwa Eid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aerobic exercise group (AEM)
Metformin group (M)
Arm Description
The AEM group performed aerobic exercise three times a week for 12 weeks in addition to Metformin treatment.
The M group received Metformin only
Outcomes
Primary Outcome Measures
Level of Interleukin 6
Level of TNF-α
level of C- reactive protein
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05233514
Brief Title
Effect of Aerobic Exercise on Polycystic Ovary Syndrome
Official Title
Effect of Aerobic Exercise on Inflammatory Markers in Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise group (AEM)
Arm Type
Experimental
Arm Description
The AEM group performed aerobic exercise three times a week for 12 weeks in addition to Metformin treatment.
Arm Title
Metformin group (M)
Arm Type
Active Comparator
Arm Description
The M group received Metformin only
Intervention Type
Other
Intervention Name(s)
Aerobic exercise in addition to Metformin treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of Interleukin 6
Time Frame
12 weeks
Title
Level of TNF-α
Time Frame
12 weeks
Title
level of C- reactive protein
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Marwa Eid
City
Cairo
ZIP/Postal Code
2011
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Aerobic Exercise on Polycystic Ovary Syndrome
We'll reach out to this number within 24 hrs