Effect of a Home-Designed Cardiac Rehabilitation program on blood pressure, heart rate, myocardial oxygen consumption indices and cardiovascular function in patients with coronary artery disease
Effect of a Home-Designed Cardiac Rehabilitation program on blood pressure, heart rate, myocardial oxygen consumption indices and cardiovascular function in patients with coronary artery disease, visiting to Shahid Rahimi hospital in Khorramabad
Design
The subjects of this study are clinical trials with interventional and control groups, two blinds, randomized population.
Settings and conduct
All patients with coronary artery disease referred to Shahid Rahimi hospital in khorramabad city. Following percutaneous coronary angioplasty, in phase IV cardiac rehabilitation. 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, coronary artery disease.
Exclusion criteria: At least eight weeks of myocardial infarction and two months of percutaneous coronary angioplasty
Intervention groups
The intervention group received a home cardiac rehabilitation, exercise program, and the necessity of continuing the program. The control groups, also performed the usual cardiac rehabilitation program without utilizing designed program.
Main outcome variables
Blood pressure, heart rate, myocardial oxygen consumption indices and cardiovascular function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181122041725N2
Registration date:2020-10-28, 1399/08/07
Registration timing:retrospective
Last update:2020-10-28, 1399/08/07
Update count:0
Registration date
2020-10-28, 1399/08/07
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
2020-10-09, 1399/07/18
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a Home-Designed Cardiac Rehabilitation program on blood pressure, heart rate, myocardial oxygen consumption indices and cardiovascular function in patients with coronary artery disease
Public title
The effect of home-designed cardiac rehabilitation in patients with coronary artery disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
History of angioplasty and angiography
At least eight weeks of myocardial infarction and two months of percutaneous coronary angioplasty
In order to control various factors influencing research outcomes, a set of conditions was considered to include subjects in the research. Eligible patients were assigned to the groups through the stratified randomization method. 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.1397.105
Health conditions studied
1
Description of health condition studied
Effect of program designed cardiac rehabilitation in percutaneous coronary angioplasty
ICD-10 code
I25.7
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris
Primary outcomes
1
Description
Blood pressure
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
Blood pressure device
2
Description
Heart rate
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
Electrocardiogram
3
Description
Myocardial oxygen consumption
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
Exercise test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group carried out the cardiac rehabilitation walking program using pedometers. The pedometer feedback- based 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
2
Description
Control group: The control group also performed the usual cardiac rehabilitation program without utilizing pedometer feedback.The control group had the same cardiac rehabilitation exercise program but did not use the step counter feedback.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rahimi hospital city Khorramabad
Full name of responsible person
Mostafa dehghani
Street address
No. 1, Mojahedin Street., Azadi Square
City
Korramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3333 6150
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
6814664535
Phone
+98 66 3333 6150
Email
dehghani.m66@gmail.com
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
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 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
Korramabad
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be 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
1399
To whom data/document is available
Researchers working in academia and scientific
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