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IRCT20250901067078N1 IRCT 2025-09-25 Vice Chancellor for Research and Technology, Razi University The Effect of High-Intensity Interval Training on Health Indicators in Women with Non-Alcoholic Fatty Liver Disease Effects of Eight Weeks of High-Intensity Interval Training on Inflammatory Markers in Women with Non-Alcoholic Fatty Liver Disease: A Randomized Controlled Trial 2024-09-24 anticipated 26 Complete https://irct.ir/trial/86219 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For the random allocation of participants to the study groups (Control group and High-Intensity Interval Training group), the sealed envelopes method was used. In this method, a random allocation sequence was first generated using random number software. Each allocation number was then assigned to a specific group (Control group or High-Intensity Interval Training group). These numbers were written on paper and placed into opaque, non-transparent envelopes. The envelopes were arranged completely randomly without any particular order. When each participant entered the study, one of the sealed envelopes was randomly selected and opened. Based on the number inside the envelope, the participant was assigned to one of the two groups. This method was implemented to ensure allocation concealment and to prevent bias from both the researchers and the participants. N/A Non-Alcoholic Fatty Liver Disease. Intervention 1: Control group:The control group did not receive any exercise or training intervention and continued their usual daily activities. Intervention 2: Intervention group: The intervention group will perform High-Intensity Interval Training, consisting of aerobic exercises. Sessions will be held three days per week, each lasting 45 minutes, including 5 minutes of warm-up, 30 minutes of high-intensity intervals, and 10 minutes of cool-down. All sessions will be supervised by an experienced trainer and the research team at Razi University gym, with intensity adjusted according to each participant's maximum heart rate. Yes - There is a plan to make this available What will be shared: Personal data of study participants can be shared after removing identifying information. When: The access period will begin 6 months after the results are published. To whom: The data will be available only to researchers affiliated with academic and scientific institutions. Conditions: The use of data is permitted only for conducting similar scientific research and must not be used for the personal interests of specific individuals or groups. Where to obtain: Zahra Sohrabi, Amir Abbas Monazami How to obtain: The request should be sent to the provided email address; the applicant's request will be reviewed, and the data will be sent within 5–7 days if the conditions are deemed satisfactory. Comments:
public Amir Abbas Monazami
Taq Bostan Street
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 7605 MONAZZAMI.AMIRABBAS@gmail.com Razi University of Kermanshah scientific Amir Abbas Monazami
Taq Bostan Street
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 7605 MONAZZAMI.AMIRABBAS@gmail.com Razi University of Kermanshah Iran (Islamic Republic of) Female gender Patients with non-alcoholic fatty liver disease (grade 1 or 2, confirmed by ultrasound and a physician) Overweight or obesity (body mass index between 25 and 35) No history of using liver-related or metabolic medications 30 years 50 years Female Regular physical activity during the past three months Occurrence of medical problems or sports injuries during the study Presence of specific diseases or use of special medications (cardiovascular, respiratory, renal, metabolic diseases, or cancer) Absence from more than three training sessions K76.0 Fatty (change of) liver, not elsewhere classified N/A Treatment - Other Control group:The control group did not receive any exercise or training intervention and continued their usual daily activities Intervention group: The intervention group will perform High-Intensity Interval Training, consisting of aerobic exercises. Sessions will be held three days per week, each lasting 45 minutes, including 5 minutes of warm-up, 30 minutes of high-intensity intervals, and 10 minutes of cool-down. All sessions will be supervised by an experienced trainer and the research team at Razi University gym, with intensity adjusted according to each participant's maximum heart rate. Interleukin-6 (IL-6). Timepoint: Pre- and post-intervention. Method of measurement: Serum interleukin-6 (IL-6) concentration was measured using the Immulite IL-6 kit and an immunochemical method based on the Immulite 2000 system. C-Reactive Protein. Timepoint: Pre- and post-intervention. Method of measurement: C-reactive protein (CRP) levels were measured using the CRP-H917-S kit manufactured by Delta Pars Company and the latex immunoturbidimetric method. Cortisol. Timepoint: Pre- and post-intervention. Method of measurement: Cortisol levels were measured using a fully automatic IMMULITE 2000XPi device. This device employs the electrochemiluminescence chemistry method. The kits used were specifically designed for this device and in accordance with international standards. Body composition. Timepoint: Pre- and post-intervention. Method of measurement: Measurements were performed using scales, a stadiometer, the body mass index (BMI), and a body composition assessment device. Lipid profile. Timepoint: Pre- and post-intervention. Method of measurement: Measurements were performed using the respective kits and automated analyzers. Liver enzymes. Timepoint: Pre- and post-intervention. Method of measurement: Measurements were performed using the respective kits and automated analyzers. Fasting blood insulin. Timepoint: پیش و پس از مداخله. Method of measurement: Fasting insulin levels were measured using a human insulin enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer’s instructions. Fasting blood glucose. Timepoint: Pre- and post-intervention. Method of measurement: Measurements were performed using a glucose kit and automated analyzers. Maximal aerobic capacity. Timepoint: Pre- and post-intervention. Method of measurement: Shuttle Run Test. Vice Chancellor for Research and Technology, Razi University Approved 2022-11-09 The ethics committee of Razi University of Kermanshah Taq Bostan Street Kermanshah Kermanshah Iran (Islamic Republic of)