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Clinical Trial Summary

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is the leading cause of infertility and anovulation. According to the Rotterdam criteria, the prevalence of PCOS is estimated to affect up to 20% of the female population. PCOS is characterized by increased androgen production and decreased ovulation leading to clinical manifestations including acne, hirsutism, male pattern baldness, irregular menstrual cycles, and infertility. In addition to concerns about fertility and hyperandrogenism, PCOS is considered a metabolic disorder, with an increased risk of developing insulin resistance (IR), hyperinsulinemia, dyslipidemia, and low-grade inflammation. In addition to genetic involvement, environmental aspects such as obesity conditions. affect the progression of PCOS or even make patients' clinical conditions worse. Exercise is an important component of PCOS management, and exercises have been shown to improve metabolic and reproductive outcomes in women with PCOS. The study will be a randomized clinical trial. This study will be completed in a time duration of 7 months after the approval of the synopsis. Sample size 32 is calculated by the Epi tool.variable for the sample size is BMI. By the non-probability convenience sampling technique, participants will be divided into 2 groups. Group A the Interventional group will receive SIT and Group B will receive the aerobic exercise. Group A will perform SIT 3 times a week for 30-second sprints on a cycle ergometer with 4 minutes of rest between each sprint, complete session will be for 30 -40 minutes while Group B will perform the aerobic exercise for 30-40 minutes of moderate-intensity continuous exercise on a treadmill and stationary cycle. The outcome measure will be evaluated by using the BMI Calculator, PCOSQOL, measuring tape Borg scale. After Collecting data from the before and after treatment sessions. The data will be analyzed by using SPSS version 25.


Clinical Trial Description

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is the leading cause of infertility and anovulation. According to the Rotterdam criteria, the prevalence of PCOS is estimated to affect up to 20% of the female population. PCOS is characterized by increased androgen production and decreased ovulation leading to clinical manifestations including acne, hirsutism, male pattern baldness, irregular menstrual cycles, and infertility. In addition to concerns about fertility and hyperandrogenism, PCOS is considered a metabolic disorder, with an increased risk of developing insulin resistance (IR), hyperinsulinemia, dyslipidemia, and low-grade inflammation. In addition to genetic involvement, environmental aspects such as obesity conditions. affect the progression of PCOS or even make patients' clinical conditions worse. Exercise is an important component of PCOS management, and exercises have been shown to improve metabolic and reproductive outcomes in women with PCOS. The study will be a randomized clinical trial. The study will be conducted in the settings of Jinnah Hospital Lahore, Shapes Gym, and UFC Gym. This study will be completed in a time duration of 7 months after the approval of the synopsis. Sample size 32 is calculated by the Epi tool.variable for the sample size is BMI. By the non-probability convenience sampling technique, participants will be divided into 2 groups. Group A the Interventional group will receive SIT and Group B will receive the aerobic exercise. Group A will perform SIT 3 times a week for 30-second sprints on a cycle ergometer with 4 minutes of rest between each sprint, complete session will be for 30 -40 minutes while Group B will perform the aerobic exercise for 30-40 minutes of moderate-intensity continuous exercise on a treadmill and stationary cycle. The outcome measure will be evaluated by using the BMI Calculator, PCOSQOL, measuring tape Borg scale. After Collecting data from the before and after treatment sessions. The data will be analyzed by using SPSS version 25. Keywords: Body Mass Index, High-Intensity Interval Training, Polycystic Ovary Syndrome, Quality of Life ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06461585
Study type Interventional
Source Riphah International University
Contact Iqbal Tariq, PhD
Phone 03458236752
Email iqbal.tariq@riphah.edu.pk
Status Recruiting
Phase N/A
Start date December 10, 2023
Completion date July 10, 2024

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