Effects of HICT and Intermittent Fasting on PCOS

NCT06302166 | Recruiting

• 1 other identifier: REC/MS-PT/01720
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Polycystic Ovary Syndrome; PCO

Keywords

PCO; Polycystic Ovary syndrome; Females; Body Image concerns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Anthropometrics

  8th Week

• Clinical Hyperandrogenism

  8th Week

• Body Image concerns

  8th Week

Study Arms (3)

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.

Other: High Intensity Circuit training (HICT)

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).

Other: Intermittent Fasting (IF)

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.

Other: Combination of HICT and IF

Interventions

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.

High Intensity circuit training (HICT)

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.

Intermittent fasting (IF)

Combination of HICT and IF OTHER

The participants will follow both HICT and IF for 8 weeks.

Combination of HICT and IF

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Unmarried females
• Diagnosed with PCOS Phenotype A based on Rotterdam Criteria:
• PCOM on US
• Ovulatory dysfunction
• Clinical Hyperandrogenism (Hirsutism modified Ferriman Gallway score ≥ 8)

You may not qualify if:

• Use of Estrogen, Progestin or combination.
• Type I or II DM
• Hypo/hyperthyroidism
• BMI ≥27 (Obese according to BMI Asia)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Bilal Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

RECRUITING

Noor Clinic

Rawalpindi, Punjab Province, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Sarah Ehsan, PP-DPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

033324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: March 15, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)