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Effects of HICT and Intermittent Fasting on PCOS

Not Applicable
Recruiting
Conditions
Polycystic Ovary Syndrome
PCO
Interventions
Other: High Intensity Circuit training (HICT)
Other: Combination of HICT and IF
Other: Intermittent Fasting (IF)
Registration Number
NCT06302166
Lead Sponsor
Riphah International University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
33
Inclusion Criteria
  • Unmarried females

  • Diagnosed with PCOS Phenotype A based on Rotterdam Criteria:

    • PCOM on US
    • Ovulatory dysfunction
    • Clinical Hyperandrogenism (Hirsutism modified Ferriman Gallway score ≥ 8)
  • Not engaged in any regular lifestyle intervention for <3 Months prior to inclusion

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Exclusion Criteria
  • Use of Estrogen, Progestin or combination.
  • Taking medications or supplements for Insulin resistance < 3 months prior to the inclusion
  • Type I or II DM
  • Hypo/hyperthyroidism
  • BMI ≥27 (Obese according to BMI Asia)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
High Intensity circuit training (HICT)High Intensity Circuit training (HICT)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.
Combination of HICT and IFCombination of HICT and IFThe 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.
Intermittent fasting (IF)Intermittent Fasting (IF)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).
Primary Outcome Measures
NameTimeMethod
PCOS Morphology8th Week

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 .

Secondary Outcome Measures
NameTimeMethod
Body Image concerns8th Week

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.

Anthropometrics8th Week

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.

Clinical Hyperandrogenism8th Week

Changes from baseline Modified Ferriman Gallwey (mFG) score will be used to assess the hirsutism as a measure of clinical hyperandrogenism.

Trial Locations

Locations (2)

Bilal Hospital

🇵🇰

Rawalpindi, Punjab, Pakistan

Noor Clinic

🇵🇰

Rawalpindi, Punjab, Pakistan

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