High Intensity Interval Training in PCOS

Study Overview
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Brief Summary
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Study objective is to determine the effect of High intensity interval training on psychological wellbeing, Anthropometrics and Quality of life in females with Polycystic Ovarian Syndrome

Official Title
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Effects of High Intensity Interval Training on Psychological Well Being, Anthropometrics, and Quality of Life in Females With Polycystic Ovarian Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: Low Intensity steady state training
* Other: High intensity interval training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: females 18 to 45 years of age Diagnosed with PCOS based on Rotterdam criteria Ferriman and Gallway score of >8 for hirsutism Exclusion Criteria: Use of hormonal contraceptives or IUDs for contraception Taking metformin <3 months prior to the inclusion Breast feeding mothers Type I or II DM Hypo/hyperthyroidism Regular high-intensity endurance or strength training (defined as ≥ 2 sessions of vigorous exercise per week), Physical ailments/injuries that limited exercise performance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Intensity steady state training<br>Intervention will be provided for a period of 8 weeks. For the first 4 weeks the intervention will consist of 35-40 minutes of supervised slow paced treadmill walk, five days a week. From week 5 till 8 the intervention will consist of 50-60 minutes of supervised slow paced treadmill walk, five days a week. | Other: Low Intensity steady state training<br>* Intervention will be provided for a period of 8 weeks. For the first 4 weeks the intervention will consist of 35-40 minutes of supervised slow paced treadmill walk, five days a week. From week 5 till 8 the intervention will consist of 50-60 minutes of supervised slow paced treadmill walk, five days a week.<br>|
| Experimental: High intensity interval training<br>Intervention will be provided for a period of 8 weeks, thrice a week. Intervention will start with a 5 minutes warm up period of jogging in place. For the first 4 weeks, 3 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery. Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches. Intervention will start with a 5 minutes warm up period of jogging in place. For weeks 5 to 8, 4 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery. Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches. | Other: High intensity interval training<br>* Intervention will be provided for a period of 8 weeks, thrice a week. Intervention will start with a 5 minutes warm up period of jogging in place. For the first 4 weeks, 3 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery. Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches. Intervention will start with a 5 minutes warm up period of jogging in place. For weeks 5 to 8, 4 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery. Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Well-being | Changes from the baseline Warwick Edinburgh Mental Well-being Scale is a 14 item scale of mental well-being covering subjective well-being and psychological functioning, in which all items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a1 to5 scale. The minimum scale score is 14 and the maximum is 70. | 8th Week | 
| Illness perception | Changes from the baseline The Brief Illness Perception Questionnaire (IPQ) it consists of 9 items rated on a scale of 0 to 10. First five items asses such as effect on life (item 1); duration of illness (item 2); control over illness (item 3); beliefs about the effectiveness of treatment (item 4); and experience of symptoms (item 5). Items 6 and 8 assess emotional aspects to include concern about illness and a multifaceted question about mood. Item 7 assesses degree of understanding of the illness. The final item is open-ended, asking respondents to rank the three most important factors causing their illness. . A higher score reflects a more threatening view of the illness. | 8th Week | 
| weight | Changes from the baseline the Weight will be measured using a digital weighing scale in kilograms. | 8th week | 
| BMI | Changes from the baseline the BMI will be measured by dividing weight in kilograms by height in centimeters. BMI Asian will be used for categorization i.e. less than 18.5 kg/m2 is underweight, 18.5 to 23 18.5 kg/m2 is normal, 23 to 27.5 18.5 kg/m2 is overweight and more than 27 18.5 kg/m2 is obese. | 8th week | 
| waist-to-hip ratio | changes from the baseline waist to hip ratio will be measured using a measuring tape. A score of less than 0.8 is considered normal, 0.81 to 0.85 is moderate and more than 0.86 is higher. | 8th Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polycystic ovary syndrome health-related Quality of life questionnaire | Changes from the baseline The PCOSQ contains the following domains: emotions (8 items), hirsutism (5 items), weight (5 items), infertility (4 items), and menstrual disorders (4 items). Each item can be answered by choosing from a Likert scale with 7 options from 1 (always) to 7 (never). Higher scores are indicative of better function. | 8th Week |