High Intensity Resistance and Aerobic Training Among Women With PCOS

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT05603169
• Lead Sponsor: Riphah International University

Brief Summary

polycystic ovarian syndrome (PCOS) is the most common endocrine female disorder, affecting 4-18% women of reproductive age. The prevalence of PCOS in South Asian women, especially in Pakistani women, is much higher (52%) as compared to white population (20 - 25% in UK). On the basis of cultural, environment, diet and lifestyle practices these women are more prone to development of such disorder. So such public health issue needs to be addressed by strong evidence conducted by a clinical trial. The current study is planned to compare effects of two different exercise protocols of high intensity on anthropometric measures, hormonal profile and quality of life.

Detailed Description

PCOS is a prevalent condition that is affecting adolescent girls now and has serious impacts on menstrual health and quality of life making them prone to early risk development for chronic metabolic diseases. The comparison between high intensity resistance and aerobic training would give results that which one is more effective in gaining benefits and better effects on overall health both physically(menstrual) as well as mentally that would eventually tell us about the quality of life of such patients.

After the initial screening process, the participants fulfilling the Roterdam criteria, willing to participate in the exercise trial will be recruited and then randomized to the allocated groups of either high intensity resistance or high intensity aerobics. At baseline, their anthropometrics measurements, LH/FSH ratios and fasting plasma glucose test will be done. Patient will be called thrice a week for 3 months for training. It is hypothesized that high intensity resistance or high intensity aerobics will improve anthropometric measures along with hormonal profile and quality of life.

Study Timeline

• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-10-28
• Study Start: 2022-11-01
• Study First Posted: 2022-11-02
• Status Verified: 2023-05
• Primary Completion: 2023-05-10
• Study Completion: 2023-05-10
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Women diagnosed with PCOS according to Rotterdam criteria
• Age limit: 18-30
• Women who are not part of planned physical activity for the last six months.
• BMI<=30

Exclusion Criteria

• Women with PCOS who are already on birth control or hormone therapy.
• Women with PCOS who are already are taking some medication for psychological issues
• Women who are already taking cholesterol control medications.
• Women who are a part of any physical activity already

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Mass Index	changes from 8 weeks to 12 weeks	Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Polycystic ovarian syndrome questionnaire (PCOSQ)	changes from 6 weeks to 12 weeks	The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.
Waist Hip Ratio	changes from 8 weeks to 12 weeks	The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
SF-36 QOL	changes from Baseline to 6 weeks	The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
SF-36 Quality of life	changes from 6 weeks to 12 weeks	The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)

Secondary Outcome Measures

Name	Time	Method
LH/FSH ratios	changes from Baseline to 3 Months	Luteinizing hormone (LH), follicle-stimulating hormone (FSH), and LH/FSH ratio will be measured when considering a PCOS diagnosis. The LH/FSH ratio is a valid and frequently employed method to test the ovulation and menstrual health of such women and have been reported by many studies

Trial Locations

Locations (1)

PostGraduate Lab FRAHS; 🇵🇰 Islamabad, Fedral, Pakistan