The effect of Resoratol supplementation with and without exercise rehabilitation training versus no intervention on inflammatory factors and lipid profile in cardiac patients undergoing coronary artery bypass graft surgery: a randomized clinical trial
To assess the effect of Resoratol supplementation with and without exercise rehabilitation training versus no intervention on inflammatory factors and lipid profile in cardiac patients undergoing coronary artery bypass graft surgery
Design
This is a randomized clinical trial, phase II, in which 40 eligible patients will be randomly assigned to three intervention groups and one control group
Settings and conduct
The eligible cardiac patients undergoing coronary artery bypass graft surgery who will refer to Farshchian Heart Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 80 years
Cardiac patients undergoing coronary artery bypass graft surgery
Exclusion criteria:
Cardiac angina during exercise testing
Intervention groups
Intervention group 1: Oral Resoratol supplementation daily for 3 months
Intervention group 2: Physical activity consists of 5 to 10 minutes of warming and then endurance exercises including treadmill or working wheel for heart rehabilitation for 15 to 20 minutes with intensity of 50 to 70% 3 times a week for 3 months
Intervention group 3: Oral Resoratol supplementation daily for 3 months plus physical activity consists of 5 to 10 minutes of warming and then endurance exercises including treadmill or working wheel for heart rehabilitation for 15 to 20 minutes with intensity of 50 to 70% 3 times a week for 3 months
Control group: Without any intervention
Main outcome variables
Primary outcome:
Assessing inflammatory factors (CRP, TNFα, Interlukin-6) before intervention and 3 months after intervention though laboratory testing
Assessing lipid profile (LDL, HDL) before intervention and 3 months after intervention though laboratory testing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N221
Registration date:2018-05-21, 1397/02/31
Registration timing:retrospective
Last update:2018-05-21, 1397/02/31
Update count:0
Registration date
2018-05-21, 1397/02/31
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
2016-10-22, 1395/08/01
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Resoratol supplementation with and without exercise rehabilitation training versus no intervention on inflammatory factors and lipid profile in cardiac patients undergoing coronary artery bypass graft surgery: a randomized clinical trial
Public title
The effect of Resoratol supplementation with and without exercise rehabilitation training versus no intervention on inflammatory factors and lipid profile in cardiac patients undergoing coronary artery bypass graft surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 80 years
Cardiac patients undergoing coronary artery bypass graft surgery
Exclusion criteria:
Cardiac angina during exercise testing
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2016-10-18, 1395/07/27
Ethics committee reference number
IR.UMSHA.REC.1395.329
Health conditions studied
1
Description of health condition studied
Cardiac patients undergoing coronary artery bypass graft surgery
ICD-10 code
I25.70
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris
Before intervention and 3 months after intervention
Method of measurement
Though laboratory testing
2
Description
Assessing lipid profile (LDL, HDL)
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Though laboratory testing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Oral Resoratol supplementation daily for 3 months
Category
Treatment - Drugs
2
Description
Intervention group 2: Physical activity consists of 5 to 10 minutes of warming and then endurance exercises including treadmill or working wheel for heart rehabilitation for 15 to 20 minutes with intensity of 50 to 70% 3 times a week for 3 months
Category
Rehabilitation
3
Description
Intervention group 3: Oral Resoratol supplementation daily for 3 months plus physical activity consists of 5 to 10 minutes of warming and then endurance exercises including treadmill or working wheel for heart rehabilitation for 15 to 20 minutes with intensity of 50 to 70% 3 times a week for 3 months
Category
Treatment - Drugs
4
Description
Control group: Without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital
Full name of responsible person
Dr Javad Almasi
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
almasi.javad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Javad Almasi
Street address
Vice-chancellor for Research and Technology, Islamic Azad University, Hamadan Brunch, Imam Khomeini Ave.
City
Hamadan
Province
Hamadan
Postal code
6518115743
Phone
+98 81 3448 1000
Email
almasi.javad@yahoo.com
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
Dr Javad Almasi
Position
Sport Physiologist
Latest degree
Medical doctor
Other areas of specialty/work
Physiology
Street address
Islamic Azad University, Hamadan Brunch, Imam Khomeini Ave.
City
Hamadan
Province
Hamadan
Postal code
6518115743
Phone
+98 81 3838 1740
Email
almasi.javad@yahoo.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
Medical doctor
Other areas of specialty/work
Physiology
Street address
Islamic Azad University, Hamadan Brunch, Imam 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