Protocol summary

Study aim
The effect of a combined training session on lipid profile; APOA levels and ABCB4 gene expression of white blood cells in middle-aged men after cardiovascular bypass surgery
Design
The statistical sample of this study consisted of 30 middle-aged men who had previously undergone coronary artery bypass grafting.This is a quasi-experimental study that was randomly divided into two groups of control (n = 15, endurance and resistance combined training (n = 15) by selective sampling.
Settings and conduct
All stages of the study will be performed in compliance with the rules of research ethics and under the supervision of the ethics committee of Javadalameh Cardiovascular Hospital in Mashhad. After the initial blood sampling, samples will be pre-tested and at the end of 24 sessions post-test will be performed.Walking on a treadmill for 20 to 30 minutes, pedaling on a stationary bike for 10 to 12 minutes, using a manual ergometer for 10 minutes, and resistance training include: three repetitive sets; three movements for the upper limbs and two movements for the lower limbs.
Participants/Inclusion and exclusion criteria
1. Have previously undergone coronary artery bypass graft surgery. 2 have a relative readiness to perform exercises. 3. Between 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
ABCB4 gene expression ;APOA levels ;Lipid profile;

General information

Reason for update
Acronym
CABG
IRCT registration information
IRCT registration number: IRCT20201117049424N1
Registration date: 2021-06-09, 1400/03/19
Registration timing: retrospective

Last update: 2021-06-09, 1400/03/19
Update count: 0
Registration date
2021-06-09, 1400/03/19
Registrant information
Name
Robabe Mahmoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4333 4828
Email address
r.mahmodi@iau-neyshabur.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-24, 1396/06/02
Expected recruitment end date
2018-05-23, 1397/03/02
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 a combined training course on lipid profile; APOA levels and expression of ABCB4 white blood cell gene in middle-aged men after cardiovascular bypass surgery
Public title
We perform combined exercises that include aerobic and resistance training on subjects who are middle-aged men who have undergone cardiac bypass surgery. We examined its effects on ABCB4 gene expression, APOA levels and reverse cholesterol transfer.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Systolic blood pressure greater than 160 mmHg and diastolic blood pressure higher than 100 mmHg. Cognitive, visual and auditory health Use walking aids such as canes and walkers. eir operating capacity should not be less than five meters. Hermet expresses consumption of 3.5 ml of oxygen per kilogram of body weight per minute, which was estimated based on the modified Bruce test (Fallahi Vagini 2012). Use of neuroleptics. Age range 50 to 60 years At least two months have passed since their operation
Exclusion criteria:
Unstable angina Uncompensated heart failure Myocardial infarction over the past four weeks Ventricular arrhythmia
Age
From 50 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 15
Actual sample size reached: 30
More than 1 sample in each individual
Actual sample size in each individual: 15
There will be 15 participants in the control group and 15 participants in the experimental group
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 will be performed on patients with coronary artery bypass grafting and will examine the effect of rehabilitation exercises on patients with coronary artery bypass grafting.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University of Neyshabour
Street address
Neishabour Islamic Azad University
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319975853
Approval date
2017-04-23, 1396/02/03
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1399.026

Health conditions studied

1

Description of health condition studied
Cardiovascular disease
ICD-10 code
ICD-10 code description
I60-I69بیماریهای قلبی وعروقی

2

Description of health condition studied
Coronary artery diseaseI70-I79
ICD-10 code
ICD-10 code description
I70-I79بیمارشریان کرونری

3

Description of health condition studied
Circulatory system diseaseI95-I99
ICD-10 code
ICD-10 code description
اختلالات نامشخص سیستم گردش خونI95-I99

Primary outcomes

1

Description
ABCB4 gene expression
Timepoint
24 hours before the start of the protocol and 48 hours after the last training session
Method of measurement
ABCB4 gene expression and ELISA method

2

Description
APOA plasma levels,
Timepoint
24 hours before the start of the protocol
Method of measurement
Gene expression and ELISA method

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group": 8 weeks of cardiac rehabilitation (aerobic training and resistance training) including 3 sessions per week with an intensity of 50-80% of the reserve heart rate or Burg criterion the 13-11 depending on the strength of the tests and for each session up to 90 minutes as follows: "Intervention group 1:; 2,Walking on a treadmill for 20 to 30 minutes ",;;" Intervention group: 1:; 3, pedaling on a stationary bike 12-10 minutes ";: Intervention group: 1:; 4, using manual ergometer is 10 minutes and resistance training includes:" Intervention group 1:5; There are three movements for the upper limb and two movements for the lower limb.
Category
Prevention

2

Description
Control group: Control group: No exercise was given to the control group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Javadalameh Cardiovascular Hospital, Mashhad
Full name of responsible person
Dr Emad Alaviniya
Street address
Vakilabad Boulevard. Conservatory Boulevard. Conservatory 1
City
MASSHAD
Province
Razavi Khorasan
Postal code
9178613111
Phone
+98 51 3883 1841
Fax
+98 51 3883 8103
Email
Info@jhosp.org
Web page address
http://wwWJhosp.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Rambod Khajeh
Street address
Neishabour Azad University
City
Neishabour
Province
Razavi Khorasan
Postal code
۹۳۱۹۷۹۷۱۳۹
Phone
+98 51 4262 1901
Fax
+98 51 4261 5472
Email
Neyshabur@iau-neyshabur.ac.ir
Web page address
http://www.Neyshabur.iau.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Neishabour 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
Amir Rashid lamir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Hashemiye14
City
Mashhad
Province
Razavi Khorasan
Postal code
91786131119
Phone
+98 51 3380 6000
Fax
+98 51 3880 2000
Email
Rashidlamir@um.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Rashidlamir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Hashemiye14
City
Masshad
Province
Razavi Khorasan
Postal code
9178613111
Phone
+98 51 3880 6000
Fax
+98 51 3880 6000
Email
amir.rashidlamir@gmail.com
Web page address
http://www.fum.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Rashidlamir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Hashemiye14
City
Mashhad
Province
Razavi Khorasan
Postal code
9178613111
Phone
+98 51 3880 6000
Fax
+98 51 3880 8000
Email
Amir.rashidlamir@gmail.com
Web page address
http://www.fum.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
No - There is not 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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