Effect of morning-and-evening of an 8-week Cardiac Rehabilitation program on indices, CTnI fat profiles, CRP and platelet among male patients with myocardium infraction
The present study aimed to investigate the effects of cardiac rehabilitation program conducted in either the morning or evening on indices, CTnI , fat profiles, CRP and platelets in MI patients who were at the phase IV (maintenance) of the disease.
Design
The subjects of this study are clinical trials with interventional and control groups, two blinds, randomized male population.
Settings and conduct
All patients with myocardial infarction referred to Shahid Madani hospital in khorramabad city. sampling method is a randomized categorical method based on inclusion criteria and available criteria. The eligible individuals are divided into subgroups of morning and evening, and subjects under the floor are randomly assigned to four intervention and control groups Will take.
Participants/Inclusion and exclusion criteria
Inclusion criteria: history of angioplasty and coronary artery disease, elapsing at least eight weeks of MI.
Exclusion criteria: ejection fraction less than 40% and more than 55%, uncontrolled metabolic diseases.
Intervention groups
The intervention groups received a based home cardiac rehabilitation, exercise program, and the necessity of continuing the program. The control groups, also performed the usual cardiac rehabilitation program without utilizing exercise program.
Main outcome variables
Troponin, C-Reactive Protein, Platelets
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181122041725N3
Registration date:2020-10-31, 1399/08/10
Registration timing:retrospective
Last update:2020-10-31, 1399/08/10
Update count:0
Registration date
2020-10-31, 1399/08/10
Registrant information
Name
Mostafa Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3263 0659
Email address
dehghani.m66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2019-11-01, 1398/08/10
Actual recruitment start date
2020-04-03, 1399/01/15
Actual recruitment end date
2020-04-18, 1399/01/30
Trial completion date
2020-06-21, 1399/04/01
Scientific title
Effect of morning-and-evening of an 8-week Cardiac Rehabilitation program on indices, CTnI fat profiles, CRP and platelet among male patients with myocardium infraction
Public title
The effect of cardiac rehabilitation in patients with myocardial infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
history of angioplasty and coronary artery disease
ejection fraction less than 40% and more than 55%
Exclusion criteria:
ventricular arrhythmias
endocrine diseases
Age
From 45 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients were assigned to the groups through the stratified randomization method. People were first divided into two strata of morning and evening. Then, the subjects were selected from the strata through the block randomization method and divided into the intervention and control groups according to the order of the selected block number and the internal arrangement of blocks. The selected block number by luck. It should be noted that to blind the person who performed the sampling and to prevent the prediction of allocation, the size of the blocks was not written in the protocol.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial, which the patients were unaware of their allocation to the various groups Moreover, the researcher who was collecting various consequences of interventions will not be aware of group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
No. 2, Lorestan University of Medical Sciences., Anooshirvan Rezaei Square
City
Korramabad
Province
Lorestan
Postal code
6813833946
Approval date
2020-10-07, 1399/07/16
Ethics committee reference number
IR.LUMS.REC.1399.200
Health conditions studied
1
Description of health condition studied
Effect of cardiac rehabilitation in myocardial infarction
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Blood indicators
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
Blood test
2
Description
Troponin I
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
Blood test
3
Description
Cholesterol
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
Blood test
4
Description
High-density lipoprotein
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
Blood test
5
Description
Low-density lipoprotein
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
Blood test
6
Description
Triglyceride
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention groups (morning and evening) carried out the cardiac rehabilitation walking program. The home cardiac rehabilitation program in this research included walking at home for almost 45-60 min (5-min warm-up, 40- min walking, and 5- min cool-down and stretching exercises).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani hospital city khorramabad
Full name of responsible person
Mostafa dehghani
Street address
No. 1, Khairabad Street., Shaghayegh Square
City
Korramabad
Province
Lorestan
Postal code
6814664535
Phone
+98 61 4466 7956
Email
dehghani.m66@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
ٍEbrahim fallahi
Street address
No. 2, Lorestan University of Medical Sciences., Anooshirvan Rezaei Square
City
Korramabad
Province
Lorestan
Postal code
381251698
Phone
+98 66 3312 0172
Email
research@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mostafa Dehghani
Position
Domestic
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
No. 7, West Kakavand Street., Alavi Square
City
Korramabad
Province
Lorestan
Postal code
6814664535
Phone
+98 66 3333 6150
Email
dehghani.m66@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mostafa Dehghani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
No. 7, West Kakavand Street., Alavi Square
City
Korramabad
Province
Lorestan
Postal code
6814664535
Phone
+98 66 3333 6150
Email
dehghani.m66@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mostafa Dehghani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
No. 7, West Kakavand Street., Alavi Square
City
Khoramabad
Province
Lorestan
Postal code
6814664535
Phone
+98 66 3333 6150
Email
dehghani.m66@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, such as the original outcome information
When the data will become available and for how long
2020
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Researchers
From where data/document is obtainable
Telephone
What processes are involved for a request to access data/document
Phone numbers, or email addresses, along with the names and addresses of individuals