The effect of eight weeks of combined training on the serum macrophages phenotype of cardiac patients after coronary coronary artery bypass graft surgery
The aim of the present study is to investigate the effect of eight weeks of combined training on serum macrophages phenotype after coronary arteries bypass graft surgery.
Design
Clinical trial with control group, Parallel groups, Not blinded, Not randomized
Settings and conduct
Study population of patients with coronary artery bypass graft surgery which has positive exercise test and are not present in the cardiac rehabilitation of Afshar Hospital in Yazd. Patients are not willing to take part in the study or create any cardiovascular disease or skeletal problem during the study will be dropped out. Individuals in non-randomly divided into two groups, including a group that will receive cardiac rehabilitation and drug treatment, and the control group that will only receive pharmaceutical treatment. In each group, 10 people will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Coronary artery bypass graft surgery, low risk and Ejection fraction of 30%.
Exclusion criteria: unstable angina, uncorrected heart failure, cardiac infarction over the past four weeks, ventricular arrhythmias.
Intervention groups
Intervention group:8 weeks cardiac rehabilitation (aerobic exercises and resistance training) included 3 sessions per week with an intensity of 50-80% of the heart rate reserve or the criterion of Borg 11-13 depending on the ability of the subjects and the resistance training consists of three repetitive sets, three movements for upper limbs and two lower extremity movements. Training course with the usual treatment of cardiac risk factors will include high hyperlipidemia and hypertension.
Control group: Those who do not participate in the rehab program despite their doctor's recommendation and the usual treatment.
Main outcome variables
Classical Macrophage ,Alternative Macrophage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190529043755N1
Registration date:2019-07-01, 1398/04/10
Registration timing:retrospective
Last update:2019-07-01, 1398/04/10
Update count:0
Registration date
2019-07-01, 1398/04/10
Registrant information
Name
Mohammad Marandi
Name of organization / entity
University of Esfahan
Country
Iran (Islamic Republic of)
Phone
+98 35 3522 8570
Email address
s.mmarandi@spr.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
2018-01-10, 1396/10/20
Actual recruitment end date
2018-11-14, 1397/08/23
Trial completion date
2018-11-14, 1397/08/23
Scientific title
The effect of eight weeks of combined training on the serum macrophages phenotype of cardiac patients after coronary coronary artery bypass graft surgery
Public title
Combined training on the serum macrophages phenotype of cardiac patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients after Coronary Artery Bypass Graft Surgery
Surgical Injection site restoration,
Having a low risk and Ejection fraction of 30%
Exclusion criteria:
Unstable angina
Cardiac insufficiency not compensated
Myocardial infarction over the past four weeks,
Ventricular arrhythmia
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
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 in Shahid Sadoughi University of Medical Sciences of Yazd
Street address
Central Organization of Medical Sciences and Health Services,Martyr Dr. Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.SSU.REC.1396.108
Health conditions studied
1
Description of health condition studied
Patients after Coronary Artery Bypass Graft Surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Classical Macrophage Serum Level
Timepoint
24 hours prior to baseline and 24 hours after the intervention period
Method of measurement
Elisa Kit
2
Description
Alternative Macrophage Serum Level
Timepoint
24 hours prior to baseline and 24 hours after the intervention period
Method of measurement
Elisa Kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention Group: 8 weeks cardiac rehabilitation (aerobic exercises and resistance training) included 3 sessions per week with an intensity of 50-80% of the heart rate reserve or the criterion of Borg 11-13 depending on the ability of the subjects and for each session up to 90 minutes as follows:Walking on the treadmill 20 to 30 minutes, the pedal on the fixed bike 10 to 12 minutes, the use of a handheld meter is 10 minutes and the resistance training consists of three repetitive sets, three movements for upper limbs and two lower extremity movements. Training course with the usual treatment of cardiac risk factors will include high hyperlipidemia and hypertension. The exercises will be carried out by observing the principle of overload.
Category
Rehabilitation
2
Description
Control group: Those who do not participate in the rehab program despite their doctor's recommendation and will have the usual treatment of heart disease risk factors include hyperlipidemia and hypertension.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Heart Rehabilitation Center
Full name of responsible person
Mohammad Reza Vafaei Nasab
Street address
Afshar Hospital in Yazd, Islamic Republic Boulevard
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3525 8354
Email
afsharhospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Esfahan
Full name of responsible person
Masoud Roknizadeh
Street address
University of Isfahan ,University Blvd,
City
Esfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2171
Email
rokni@sci.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Esfahan
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
University of Isfahan
Full name of responsible person
Mohammad Marandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University of Isfahan ,University Blvd
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 2640
Email
smmarandi2001@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Mohammad Marandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University Blvd, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 2640
Email
smmarandi2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Mohammad Marandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University of Isfahan ,University Blvd,
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 2640
Email
smmarandi2001@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
Due to the confidentiality of some patients' information and their dissatisfaction with the publication