The effect of eight weeks cardiac rehabilitation on LXR gene expression and serum TNFα levels in CABG patients.
Design
In the present clinical practice,subjects were 24 CABG middle aged male patient who were randomly assigned into two group: control (n=12), and combination training (n=12) groups. Each person in the community was given a card number and then put all the cards in a box and after mixing them into the box, randomly drawn the numbers out of order. And so we select the two training and control groups. This research is of non blind type.
Settings and conduct
The study was conducted at Javad Alaemeh Hospital in Mashhad under the supervision of a resident physician in the cardiac rehabilitation ward of the hospital and with a combined rehabilitation program of Strength and aerobic exercise (specified protocol) for eight weeks, three sessions per week for cabg patients. 24 hours before and 48 hours after the last cardiac rehabilitation session, all subjects’ blood samples will be taken.
Participants/Inclusion and exclusion criteria
_No systolic blood pressure greater than 160 mmHg and diastolic higher than 100 mmHg
_Not using walking aids like walking canes and walkers
Intervention groups
Exercise group, performed eight weeks Cardiac Rehabilitation Combined Exercise ( Strength and aerobic). 24 hours before and 48 hours after the last cardiac rehabilitation session, all subjects’ blood samples in two groups of control and exercise were taken and plasma and monocyte isolation were performed to measure the indices, then training group were compared with control group.
Main outcome variables
TNF alpha
LXR
General information
Reason for update
Acronym
CABG
IRCT registration information
IRCT registration number:IRCT20191230045945N1
Registration date:2020-01-12, 1398/10/22
Registration timing:retrospective
Last update:2020-01-12, 1398/10/22
Update count:0
Registration date
2020-01-12, 1398/10/22
Registrant information
Name
FAHIMEH PARHIZI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 9210
Email address
parhizif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-30, 1398/08/08
Expected recruitment end date
2019-12-01, 1398/09/10
Actual recruitment start date
2019-11-01, 1398/08/10
Actual recruitment end date
2019-12-11, 1398/09/20
Trial completion date
2019-12-11, 1398/09/20
Scientific title
The effect of eight weeks cardiac rehabilitation program on lxr gene expression and serum tnf level in cabg patients
Public title
"Effect of cardiac rehabilitation in CABG patients"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men age 40_60.
Cognitive, visual and auditory health.
No systolic blood pressure greater than 160 mmHg and diastolic higher than 100mmHg.
Not using walking aids like walking canes and walkers.
Avoid doing exercise or exercise activities while participating in research.
Exclusion criteria:
Having dangerous arrhythmias and ECG changes
Severe respiratory problems that prevent you from exercising
Age
From 45 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
2
Tnf alpha_ lxr
Actual sample size reached:
24
More than 1 sample in each individual
Actual sample size in each individual:
2
Tnf alpha_ lxr
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, each person in the target population was assigned a card number and then put all the cards in a box and after mixing them into the box, randomly and without any special sequence of numbers. Drag and drop the two groups of exercise and control.
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 committe of Azad eslamic university of neyshapior
Street address
Eghbal lahouri blv.25 street. No.29
City
Mashhad
Province
Razavi Khorasan
Postal code
۱۱۱۱۱۱۱۱۱
Approval date
2019-07-18, 1398/04/27
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1398.016
Health conditions studied
1
Description of health condition studied
Atherosclerosis_CABG
ICD-10 code
I25.708
ICD-10 code description
Atherosclerosis and coronary artery bypass graft(s)
Primary outcomes
1
Description
Lxr gene expression
Timepoint
24 hour before the start of the rehabilitation period and 48 hour after the end of the cardiac rehabilitation period
Method of measurement
10 ml of blood was collected from the brachial vein of the participants and measured by a Real-time polymerase chain reaction in the laboratory.
2
Description
Tnf alpha
Timepoint
24 hour before the start of the rehabilitation period and 48 hour after the end of the cardiac rehabilitation period
Method of measurement
10 ml of blood was collected from the brachial vein of the participants and measured by elisa in the laboratory.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, 12 cabgg men underwent eight weeks of strength and aerobic rehabilitation program in Javad Al-e-Ameh Hospital in Mashhad. They will be examined by ELISA and real_time pcr.
Category
Rehabilitation
2
Description
Control group: In this group, 12 patients without cardiac rehabilitation program were considered as the comparison group. Blood samples were taken from the patients before and after the beginning of the study to evaluate tnf alpha and lxr and were compared.