The effect of combined training on ABCG4 gene expression and interleukin 4 and interleukin 10 factors in middle-aged men's blood mononuclear cells after coronary artery bypass graft
The purpose of the present study; Evaluation of the effect of combined training on ABCG4 gene expression and the level of interleukin-4 and interleukin-4 factors in blood mono nuclear cells in middle-aged men after vascular bypass surgery (CABG)
Design
The present research design will be quasi-experimental and laboratory research and will be applied . The statistical population of the present study will consist of 60 middle-aged male patients who have previously undergone coronary artery bypass graft surgery and will be referred to Javad Al-A'meh Heart Hospital in Mashhad. They will be elected. Also about the number of subjects due to the difficulty of the test used in the study and the need to select patients who have undergone coronary artery bypass graft surgery to perform the test, and also using the Cochran's formula to determine the sample size with 95% confidence, the number 20 n =, was obtained.
Settings and conduct
All stages of the research will be carried out by observing the rules of research ethics and under the supervision of the ethics committee of Javad Al-Aimeh Cardiovascular Hospital in Mashhad and under the supervision of a cardiologist.
After the initial blood sampling, the samples will be per-tested and at the end of 24 post-test sessions.
Participants/Inclusion and exclusion criteria
1. People who have previously undergone coronary artery bypass grafting
2. In terms of physical strength, be relatively ready to do exercises
3. At least 2 months and at most 4 months have passed since the coronary artery surgery of their heart.
Intervention groups
The experimental group performed combined exercises for eight weeks, including resistance and aerobic exercises, but the control group had no activity.
Main outcome variables
The effect of a combined training course on reverse cholesterol transfer factors and reduction of inflammatory factors
General information
Reason for update
Acronym
CABG
IRCT registration information
IRCT registration number:IRCT20201115049393N1
Registration date:2021-01-30, 1399/11/11
Registration timing:retrospective
Last update:2021-01-30, 1399/11/11
Update count:0
Registration date
2021-01-30, 1399/11/11
Registrant information
Name
Fahimeh Yonesi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3501 0475
Email address
f.yonesi@iau-neyshabur.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-24, 1396/06/02
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
2018-05-23, 1397/03/02
Actual recruitment end date
2018-10-07, 1397/07/15
Trial completion date
2018-10-07, 1397/07/15
Scientific title
The effect of combined training on ABCG4 gene expression and interleukin 4 and interleukin 10 factors in middle-aged men's blood mononuclear cells after coronary artery bypass graft
Public title
The effect of combined training on ABCG4 gene expression and interleukin 4 and interleukin 10 factors in middle-aged men's blood mononuclear cells after coronary artery bypass graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. No systolic blood pressure higher than 160 mm Hg and diastolic blood pressure higher than 100 mm Hg 2. Cognitive, visual and auditory health 3. Do not use neuroleptics 4. Do not use walking aids such as canes and walkers 5. At least 2 months have passed since their operation 6. Their functional capacity should not be less than five met. Each met represents a consumption of 3.5 ml of oxygen per kilogram of body weight per minute, which was estimated based on a modified Bruce test 7. Age range 50 to 65 years
Exclusion criteria:
Unstable angina, irreversible heart failure, myocardial infarction over the past four weeks, ventricular arrhythmias.
Age
From 50 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
26
Actual sample size reached:
26
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This project is part of a doctoral thesis that has been performed on patients with coronary artery bypass grafting and examines the effect of combined rehabilitation exercises on patients with coronary artery bypass grafting.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee of Ethics in Biomedical Research, Islamic Azad University. neyshabour unit
Street address
Research Blvd., Islamic Azad University Complex, Neyshabur Branch Khorasan Razavi Province, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9319975853
Approval date
2017-04-23, 1396/02/03
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1399.016
Health conditions studied
1
Description of health condition studied
Patients with coronary artery bypass grafting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ABCG4 gene expression and plasma levels of interleukin 4 and interleukin 10
Timepoint
24 hours before the start of the protocol and 48 hours after the last training session
Method of measurement
Real-time-PCT gene expression and ELISA method
Secondary outcomes
1
Description
ABCG4 gene expression of interleukin 4 and interleukin 10
Timepoint
24 hours before and 24 hours after the first and last training session
Method of measurement
Real-time-PCR method and ELISA method
Intervention groups
1
Description
Control group: Intervention group: 8 weeks of cardiac rehabilitation (aerobic training and resistance training) including 3 sessions per week with an intensity of 80-50% of the reserve heart rate or Borg standard 11-11 depending on the ability of the subjects and for each session up to 90 minutes The following: Walking on a treadmill for 20 to 30 minutes, cycling on a stationary bike for 10 to 12 minutes, using a manual ergo meter for 10 minutes, and resistance training include three repetitive sets, three movements for the upper limbs, and two lower limbs. The training course along with the usual treatment of risk factors for heart disease will include hyperglycemia and inflammation. Exercises will be performed in accordance with the principle of overload.
Category
Rehabilitation
2
Description
Control group: During this period, this group did not have any sports activities
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Javadalameh Specialized Heart Hospital, Mashhad
Full name of responsible person
Dr. Alavinia
Street address
Honarestan Blvd, Mashhad Razavi Khorasan Province Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178613111
Phone
+98 51 3881 6014
Fax
+98 51 3883 8103
Email
dr.alavinia@yahoo.com
Web page address
http://bankpezeshkan.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Khajei
Street address
Research Street. Neyshabour Azad University
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319975853
Phone
+98 51 4246 1901
Fax
+98 51 4261 5472
Email
R.Khajei@YAHOO.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Branch of neyshabour Azad University
Proportion provided by this source
100
Public or private sector
Private
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. Amir Rashid Lamir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Hashemieh 14. Hashemieh Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9178613111
Phone
+98 51 3880 4840
Fax
+98 51 3880 6000
Email
amir.rashidlamir@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Amir Rashid Lamir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Vakilabad Street, Ferdowsi University of Mashhad, Faculty of Sports Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9178613111
Phone
+98 51 3880 6000
Fax
+98 51 3880 3000
Email
amir.rashidlamir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Amir Rashid Lamir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Vakilabad Street, Ferdowsi University of Mashhad, Faculty of Sports Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9178613111
Phone
+98 51 3880 6000
Fax
+98 51 3880 3000
Email
amir.rashidlamir@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available