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The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.
Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity circuit training (HICT) | Active Comparator | For the group allocated with exercise, high intensity circuit training (HICT) of three supervised sessions per week for 20-30 mins will be given. HICT commenced after 10 mins low to moderate intensity warm up and after completing session ended with 10 mins cool down. Intensity of exercise will be measured on borg rating of perceived exertion (RPE). Perceived exertion is how hard you feel like your body is working. Although this is a subjective measure your exertion rating based on a 0 to 10 modified borg rating scale may provide a fairly good estimate of your actual heart rate during physical activity. 0 perceiving "no exertion at all" to 10 perceiving a "maximal exertion" of effort. A moderate intensity activity will be at 3-5 perceiving "somewhat hard", similarly 6-10 will be perceived as high intensity activity. |
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| Intermittent fasting (IF) | Active Comparator | For the group allocated with intermittent fasting, a time restricted feeding (TRF) methodology will be administered. The Fasting protocol will begin with a 12-hour eating window (12:12) and will gradually go down to 8 hours eating window over a period of 8 weeks (16:8). |
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| Combination of HICT and IF | Active Comparator | The group allocated with both exercise and intermittent fasting will be provided with both HICT for three sessions per week and 8 hours' time restricted eating. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Circuit training (HICT) | Other | High Intensity circuit training consisting of circuits of high intensity exercises and progressed up to 8 weeks will be provided. |
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| Measure | Description | Time Frame |
|---|---|---|
| PCOS Morphology | Changes from baseline PCOS morphology on the ultrasound will be done by calculating the number of follicles and measuring follicle size. For this purpose, ultrasound imaging is the best option as it is both harmless and inexpensive. PCOS is considered if on ultrasound imaging there are 12 or more than 12 follicles in the ovary and has size of 2-9 mm or volume of 10 cm 3 . | 8th Week |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometrics | Changes from baseline Weight (kg) will be measured by weight scale while height (ft) will be measured by stadiometer. BMI will be calculated by dividing your weight in kilograms (kg) by your height in meters squared (m 2 ). Waist Circumference (WC) will be measured in centimeters, between the costal margin and the pelvic brim, and Hip Circumference (HC) will be measured in cm at the level of the symphysis pubis by inches tape. |
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Inclusion Criteria:
Unmarried females
Diagnosed with PCOS Phenotype A based on Rotterdam Criteria:
Not engaged in any regular lifestyle intervention for <3 Months prior to inclusion
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imran Amjad, PhD | Contact | 033324390125 | imran.amjad@riphah.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Ehsan, PP-DPT | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bilal Hospital | Recruiting | Rawalpindi | Punjab Province | 44000 | Pakistan |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Intermittent Fasting (IF) | Other | Time restricted feeding will be used in which the intervention will begin with a 12:12 window leading to a 16:8 IF protocol. |
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| Combination of HICT and IF | Other | The participants will follow both HICT and IF for 8 weeks. |
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| 8th Week |
| Clinical Hyperandrogenism | Changes from baseline Modified Ferriman Gallwey (mFG) score will be used to assess the hirsutism as a measure of clinical hyperandrogenism. | 8th Week |
| Body Image concerns | Changes from baseline Body Image concerns will be measured using The BSQ which is a self-reported measurement of the body shape concerns designed for women to measure concerns about body image problems. | 8th Week |
| Noor Clinic | Recruiting | Rawalpindi | Punjab Province | 44000 | Pakistan |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |