High Intensity Resistance and Aerobic Training Among Women With PCOS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of High Intensity Resistance and Aerobic Training Among Women With Polycystic Ovarian Syndrome.

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: High intensity resistance Exercise Training
* Other: High intensity aerobic Exercise Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment into two groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Intensity Resistance Training<br>This group will perform high intensity resistance training under supervised physiotherapist in a gym setting. The training load for the first 2 weeks will be 60%-75% of 1RM and increased to 75%-90% of 1RM the following weeks. Load would be increased if the participants will be able to perform 3 sets of 12 repetitions with that load. | Other: High intensity resistance Exercise Training<br>* The resistance training will consist of five resistance exercises (thrice a week on non-consecutive days): squat, leg press, knee extension, lunges, and abdominal crunches. Every participant will be assessed pre and post intervention for hormonal change, BMI/anthropometric measures, fasting glucose and quality of life.The plan will be followed for 12 weeks<br>|
| Active Comparator: High Intensity Aerobic Training<br>This group will perform aerobic training under supervision of a physical therapist in gym setting. To calculate exercise intensity, the HR will be maintained at 75-90% of the maximum (HRmax). The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity | Other: High intensity aerobic Exercise Training<br>* The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. | changes from Baseline to 4 weeks | 
| Body Mass Index | Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. | changes from 4 weeks to 8weeks | 
| Body Mass Index | Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. | changes from 8 weeks to 12 weeks | 
| Waist Hip Ratio | 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 | changes from Baseline to 4 weeks | 
| Waist Hip Ratio | 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 | changes from 4 weeks to 8weeks | 
| Waist Hip Ratio | 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 | changes from 8 weeks to 12 weeks | 
| Polycystic ovarian syndrome questionnaire (PCOSQ) | 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. | changes from Baseline to 6 weeks | 
| Polycystic ovarian syndrome questionnaire (PCOSQ) | 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. | changes from 6 weeks to 12 weeks | 
| SF-36 QOL | 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) | changes from Baseline to 6 weeks | 
| SF-36 Quality of life | 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) | changes from 6 weeks to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LH/FSH ratios | 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 | changes from Baseline to 3 Months |