The effect of 12 weeks of combined exercise training on serum levels of nesfatin-1 in improving liver damage markers in men with non-alcoholic fatty liver disease.
The effect of twelve weeks of combined training on liver enzymes in men with non-alcoholic fatty liver disease
Design
Experimental trial with exercise and control group, randomized on 20 patients
Settings and conduct
In the gym, doing a training program under the supervision of a trainer
Participants/Inclusion and exclusion criteria
The entry condition is to have grade 2 and 3 non-alcoholic fatty liver disease and not to consume alcohol and cigarettes
Intervention groups
The exercise intervention group, which evaluates the effect of exercise on fatty liver patients, and the control group, which does not do exercise
Main outcome variables
Liver enzyme levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240514061797N1
Registration date:2024-05-28, 1403/03/08
Registration timing:registered_while_recruiting
Last update:2024-05-28, 1403/03/08
Update count:0
Registration date
2024-05-28, 1403/03/08
Registrant information
Name
hadi goudarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4260 9702
Email address
h.goudarzi@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 12 weeks of combined exercise training on serum levels of nesfatin-1 in improving liver damage markers in men with non-alcoholic fatty liver disease.
Public title
Effect of exercise on fatty liver
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having grade 2 and 3 fatty liver
Exclusion criteria:
Having heart disease, high blood pressure and chronic diseases
Having a musculoskeletal problem
Age
From 30 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Using computer randomization methods. Using spss software, first we enter the people based on the number and select the select causes option in the data header section and then we enter the random option and the first option 50%, it tells us 10 people randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Combined exercise protocol (resistance and high-intensity interval)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Bu-Ali Sina University
Street address
Shahid Mustafa Ahmadi Roshan Chaharbagh, Boali Sina University
City
Hamedan
Province
Hamadan
Postal code
65178038695
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.BASU.REC.1402.075
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Ultrasound
Timepoint
At the beginning of the study and 12 weeks after sports training
Method of measurement
Ultrasound machine
2
Description
Liver enzymes
Timepoint
At the beginning of the study and twelve weeks after sports training
Method of measurement
Diagnostic kits of enzymes in the laboratory
3
Description
Lipid profile
Timepoint
At the beginning of the study and 12 weeks after sports training
Method of measurement
Biochemical kits in the laboratory
4
Description
blood sugar
Timepoint
At the beginning of the study and 12 weeks after sports training
Method of measurement
Blood sugar test kit
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: sports exercises that include resistance training and high-intensity interval training during twelve weeks and three sessions per week are performed in a sports club.
Category
N/A
2
Description
Control group: The group that only ultrasound and blood tests are taken before and after twelve weeks without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Zarin Kob clinic
Full name of responsible person
Hadi Goudarzi
Street address
Paradise Square
City
Boroujerd
Province
Lorestan
Postal code
6913963534
Phone
+98 66 4260 9702
Email
hadigodarzi30@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Dr. Arash Ghorbani Chaghamarani
Street address
Shahid Mustafa Ahmadi Roshan Chaharbagh, Boali Sina University
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3140 5555
Email
a.ghorbani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu-Ali Sina University
Proportion provided by this source
5
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
Bu-Ali Sina University
Full name of responsible person
Hadi Goudarzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Shahid Mustafa Ahmadi Roshan Chaharbagh, Boali Sina University
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3140 0000
Email
hadigodarzi30@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Hadi Goudarzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Boali Sina University, Shahid Mostafa Ahmadi Roshan, Chaharbagh
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۹۵
Phone
+98 81 3140 0000
Email
hadigodarzi30@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Hadi goudarzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Boali Sina University, Shahid Mostafa Ahmadi Roshan, Chaharbagh
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۹۵
Phone
+98 81 3140 0000
Email
hadigodarzi30@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The names of the participants will not be disclosedکار
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only review results can be shared
When the data will become available and for how long
6 months after printing is completed
To whom data/document is available
It is accessible to everyone
Under which criteria data/document could be used
Research works
From where data/document is obtainable
Hadi Guderzi،09015413235
What processes are involved for a request to access data/document
The questions asked in the registration process are very unclear