Protocol summary

Study aim
This study aimed to evaluate the effects of eight weeks of High-Intensity Interval Training on inflammatory markers including C-Reactive Protein, Interleukin 6, and Cortisol, liver function, anthropometric measures including weight, body mass index, and waist-to-hip ratio, and insulin sensitivity in overweight and obese women with Non-Alcoholic Fatty Liver Disease
Design
This randomized trial included 26 women with Non-Alcoholic Fatty Liver Disease confirmed by sonography, assigned using a closed-envelope method to a control group or an exercise intervention group performing (High-Intensity Interval Training).
Settings and conduct
The study will be conducted as an interventional trial at the gymnasium of Razi University in Kermanshah. All exercises will be supervised by the research team and an experienced trainer, performed in controlled environments with safety standards and accurate evaluation. The intervention will last eight weeks, and assessments will be conducted 48 hours before and after the intervention.
Participants/Inclusion and exclusion criteria
The study included 26 overweight and obese women aged 30 to 50 years, randomly assigned to exercise and control groups. Inclusion criteria were female sex, age 30–50 years, residence in Kermanshah, and body mass index between 25 and 35. Exclusion criteria were regular physical activity in the past three months, physical or musculoskeletal disabilities, use of liver-related or metabolic medications, and severe cardiovascular, pulmonary, renal, or musculoskeletal diseases.
Intervention groups
The study included two groups: a control group and a High-Intensity Interval Training group.
Main outcome variables
The measured outcomes included C-Reactive Protein ,Interleukin-6, Cortisol, liver enzymes, lipid profile, and body composition

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250901067078N1
Registration date: 2025-09-25, 1404/07/03
Registration timing: retrospective

Last update: 2025-09-25, 1404/07/03
Update count: 0
Registration date
2025-09-25, 1404/07/03
Registrant information
Name
Zahra Sohrabi
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3722 0106
Email address
z.sohrabi@stu.razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-24, 1403/07/03
Expected recruitment end date
2024-10-26, 1403/08/05
Actual recruitment start date
2022-09-03, 1401/06/12
Actual recruitment end date
2022-11-11, 1401/08/20
Trial completion date
2022-11-21, 1401/08/30
Scientific title
Effects of Eight Weeks of High-Intensity Interval Training on Inflammatory Markers in Women with Non-Alcoholic Fatty Liver Disease: A Randomized Controlled Trial
Public title
The Effect of High-Intensity Interval Training on Health Indicators in Women with Non-Alcoholic Fatty Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 26
Actual sample size reached: 26
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Razi University of Kermanshah
Street address
Taq Bostan Street
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2022-11-09, 1401/08/18
Ethics committee reference number
IR.RAZI.REC.1401.061

Health conditions studied

1

Description of health condition studied
Non-Alcoholic Fatty Liver Disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
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.

2

Description
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.

3

Description
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.

Secondary outcomes

1

Description
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.

2

Description
Lipid profile
Timepoint
Pre- and post-intervention
Method of measurement
Measurements were performed using the respective kits and automated analyzers.

3

Description
Liver enzymes
Timepoint
Pre- and post-intervention
Method of measurement
Measurements were performed using the respective kits and automated analyzers.

4

Description
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

5

Description
Fasting blood glucose
Timepoint
Pre- and post-intervention
Method of measurement
Measurements were performed using a glucose kit and automated analyzers.

6

Description
Maximal aerobic capacity
Timepoint
Pre- and post-intervention
Method of measurement
Shuttle Run Test

Intervention groups

1

Description
Control group:The control group did not receive any exercise or training intervention and continued their usual daily activities
Category
N/A

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports hall of the Faculty of Social Sciences, Razi University
Full name of responsible person
Zahra Sohrabi
Street address
Faculty of Social Sciences, Shahid Beheshti Boulevard, Opposite Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714673175
Phone
+98 83 3836 1370
Email
Zsohrabi635@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Razi University
Full name of responsible person
Keyvan Amini
Street address
Taq Bostan Street
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
info@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Razi University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Amir Abbas Monazami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Taq Bostan Street
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
MONAZZAMI.AMIRABBAS@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Amir Abbas Monazami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Taq Bostan Street
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
MONAZZAMI.AMIRABBAS@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Zahra Sohrabi
Position
Coach
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Mosvari Street
City
Kermanshah
Province
Kermanshah
Postal code
6713718699
Phone
+98 83 3722 0106
Email
zsohrabi635@gmail.com‏

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Personal data of study participants can be shared after removing identifying information.
When the data will become available and for how long
The access period will begin 6 months after the results are published.
To whom data/document is available
The data will be available only to researchers affiliated with academic and scientific institutions.
Under which criteria data/document could be used
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.
From where data/document is obtainable
Zahra Sohrabi, Amir Abbas Monazami
What processes are involved for a request to access data/document
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.
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