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Trial Title:
Effects of HICT and Intermittent Fasting on PCOS
NCT ID:
NCT06302166
Condition:
Polycystic Ovary Syndrome
PCO
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Conditions: Keywords:
PCO
Polycystic Ovary syndrome
Females
Body Image concerns
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
High Intensity Circuit training (HICT)
Description:
High Intensity circuit training consisting of circuits of high intensity exercises and
progressed up to 8 weeks will be provided.
Arm group label:
High Intensity circuit training (HICT)
Intervention type:
Other
Intervention name:
Intermittent Fasting (IF)
Description:
Time restricted feeding will be used in which the intervention will begin with a 12:12
window leading to a 16:8 IF protocol.
Arm group label:
Intermittent fasting (IF)
Intervention type:
Other
Intervention name:
Combination of HICT and IF
Description:
The participants will follow both HICT and IF for 8 weeks.
Arm group label:
Combination of HICT and IF
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.
Criteria for eligibility:
Criteria:
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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
35 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Bilal Hospital
Address:
City:
Rawalpindi
Zip:
44000
Country:
Pakistan
Status:
Recruiting
Contact:
Last name:
Sarah Ehsan, PP-DPT
Phone:
03217770829
Email:
sarah.ehsaan@riphah.edu.pk
Investigator:
Last name:
Hafsa Javed, DPT
Email:
Principal Investigator
Facility:
Name:
Noor Clinic
Address:
City:
Rawalpindi
Zip:
44000
Country:
Pakistan
Status:
Recruiting
Contact:
Last name:
Sarah Ehsan, PP-DPT
Phone:
00923217770829
Email:
sarah.ehsaan@riphah.edu.pk
Investigator:
Last name:
Hafsa Javed, DPT
Email:
Principal Investigator
Start date:
March 15, 2024
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Riphah International University
Agency class:
Other
Source:
Riphah International University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06302166
