To assess the effect of exercise versus control group on cardiac inflammatory factors in patients with liver disease
Design
This is a randomized clinical trial with control group, in which eligible patients will be randomly assigned through the drawing of lots to the intervention and control groups
Settings and conduct
This study will be performed in the Islamic Azad University in Hamadan city on 30 eligible patients. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Liver failure
Exclusion criteria:
Diabetes, asthma or cardiovascular diseases
Using tobacco, drugs, alcohol, or stimulants
Intervention groups
Intervention group:
Routine care of liver patients in addition to resistance exercises (including squat, chest press, barbell launch, front cable pull bar, abdominal crunch, barbell under chest) with an intensity of 60% to 80% for 1.5 hours a week, three sessions for 8 weeks.
Control group:
Follow-up and routine care only.
Main outcome variables
Primary outcome:
Cardiac inflammatory factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N444
Registration date:2022-10-12, 1401/07/20
Registration timing:prospective
Last update:2022-10-12, 1401/07/20
Update count:0
Registration date
2022-10-12, 1401/07/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of exercise versus control group on cardiac inflammatory factors in patients with liver disease: a randomized clinical trial
Public title
Effect of exercise versus control group on cardiac inflammatory factors in patients with liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Liver failure
Exclusion criteria:
Diabetes, asthma or cardiovascular diseases
Using tobacco, drugs, alcohol, or stimulants
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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
Ethics Committee of Islamic Azad University, Khomeini Ave.
Street address
Vice-chancellor for Research and Technology, Islamic Azad University, Khomeini Ave.
City
Hamadan
Province
Hamadan
Postal code
6518115743
Approval date
2022-08-28, 1401/06/06
Ethics committee reference number
IR.IAU.H.REC.1401.030
Health conditions studied
1
Description of health condition studied
Liver disease
ICD-10 code
K77
ICD-10 code description
Liver disorders in diseases classified elsewhere
Primary outcomes
1
Description
Cardiac inflammatory factors
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
By laboratory tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care of liver patients in addition to resistance exercises (including squat, chest press, barbell launch, front cable pull bar, abdominal crunch, barbell under chest) with an intensity of 60% to 80% for 1.5 hours a week, three sessions for 8 weeks.
Category
Treatment - Other
2
Description
Control group: Follow-up and routine care only.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University in Hamadan city
Full name of responsible person
Ahmad Fili
Street address
Islamic Azad University, Khomeini Ave.
City
Hamadan
Province
Hamadan
Postal code
6518115743
Phone
+98 81 3448 1000
Email
hmdfl971@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mansour Esmaeilpour
Street address
Islamic Azad University, Khomeini Ave.
City
Hamadan
Province
Hamadan
Postal code
6518115743
Phone
+98 81 3448 1000
Email
esmaeilpour@iauh.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad 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
Islamic Azad University
Full name of responsible person
Ahmad Fili
Position
Student of Sport Physiology
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University, Khomeini Ave.
City
Hamadan
Province
Hamadan
Postal code
6518115743
Phone
+98 81 3448 1000
Email
hmdfl971@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Javad Almasi
Position
Sport Physiologist
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University, Khomeini Ave.
City
Hamadan
Province
Hamadan
Postal code
6518115743
Phone
+98 81 3448 1000
Email
almasi.javad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available