Effects of HICT and Intermittent Fasting on PCOS

Effects of High Intensity Circuit Training and Intermittent Fasting on Polycystic Ovarian Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome; PCO
• Intervention / Treatment: Other: High Intensity Circuit training (HICT); Other: Intermittent Fasting (IF); Other: Combination of HICT and IF

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, Phd; Phone Number: 033324390125; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 44000
      • Recruiting
      • Bilal Hospital
      • Contact: Sarah Ehsan, PP-DPT; Phone Number: 03217770829; Email: sarah.ehsaan@riphah.edu.pk
      • Principal Investigator: Hafsa Javed, DPT
    • Rawalpindi, Punjab, Pakistan, 44000
      • Recruiting
      • Noor Clinic
      • Principal Investigator: Hafsa Javed, DPT
      • Contact: Sarah Ehsan, PP-DPT; Phone Number: 00923217770829; Email: sarah.ehsaan@riphah.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: High Intensity Circuit training (HICT); High Intensity circuit training consisting of circuits of high intensity exercises and progressed up to 8 weeks will be provided.
Active Comparator: 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).	Other: Intermittent Fasting (IF); Time restricted feeding will be used in which the intervention will begin with a 12:12 window leading to a 16:8 IF protocol.
Active Comparator: Combination of HICT and IF; 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.	Other: Combination of HICT and IF; The participants will follow both HICT and IF for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Sarah Ehsan, PP-DPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 19, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: PCO; Females; Polycystic Ovary syndrome; Body Image concerns
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: REC/MS-PT/01720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No