Protocol summary

Study aim
The purpose of the present study is effect of morning-and-evening supervised Home-Based Cardiac Rehabilitation (HBCR) program on echo and Electrocardiographic indices, as well as general health among male patients with myocardium infraction, visiting Madani hospital of Khorramabad.
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 (MI) referred to Shahid Madani heart hospital in khorramabad city. Following MI, 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 and/or angiography identification of moderate cardiovascular disorder. Exclusion criteria: Ejection fraction less than 40% and more than 55%, infectious diseases.
Intervention groups
The intervention groups received a feedback-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 pedometer feedback.
Main outcome variables
Injection fraction, Diastolic function, Primary and final left ventricular , Cardiac and pulmonary valve deficiencies, Cardiac and pulmonary valve stenosis, EKG changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181122041725N1
Registration date: 2018-12-19, 1397/09/28
Registration timing: retrospective

Last update: 2018-12-19, 1397/09/28
Update count: 0
Registration date
2018-12-19, 1397/09/28
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
2017-09-01, 1396/06/10
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
empty
Scientific title
Effect of morning-and-evening supervised Home-Based Cardiac Rehabilitation (HBCR) program on echo and Electrocardiographic indices, as well as general health among male patients with myocardium infraction, visiting Madani hospital of Khorramabad.
Public title
The effect of home-monitored cardiac rehabilitation in patients with myocardial infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. History of angioplasty, known coronary artery disease, or angiography with moderate cardiovascular disease (mild CAD) Lack of regular physical activity during the three months prior to the intervention, so that their activity is less than 7,500 steps per day
Exclusion criteria:
Stabilized Blood Disorder Patients who have a history of using a pacemaker
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: 40
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
Khorram Abad - Kamalundeh - Kilometer 4 Khorramabad Road, Boroujerd
City
Korramabad
Province
Lorestan
Postal code
6813833946
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.LUMS.REC.1397.105

Health conditions studied

1

Description of health condition studied
Effect of Home-based cardiac rehabilitation in myocardial infarction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Echo and Electrocardiographic parameters
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
Echo and Electrocardiography

2

Description
General health
Timepoint
Before and after 8 weeks of cardiac rehabilitation
Method of measurement
GHQ questionnaire 28 questions

Secondary outcomes

1

Description
Ejection fraction
Timepoint
Before and after 8 weeks of cardiac rehabilition
Method of measurement
Eco cardiography

2

Description
Left ventricular peak filling the initial and final
Timepoint
Before and after 8 weeks of cardiac rehabilition
Method of measurement
Eco cardiography

3

Description
Heart rate rest
Timepoint
Before and after 8 weeks of cardiac rehabilition
Method of measurement
Electrocardiogram

4

Description
Blood pressure
Timepoint
Before and after 8 weeks of cardiac rehabilition
Method of measurement
Blood pressure device

5

Description
Mean arterial pressure (pressure Drift)
Timepoint
Before and after 8 weeks of cardiac rehabilition
Method of measurement
Blood pressure device

Intervention groups

1

Description
Intervention group: The intervention groups (morning and evening) carried out the cardiac rehabilitation walking program using pedometers. The pedometer feedback- based home cardiac rehabilitation (PFHCR) 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 groups (morning and evening) also performed the usual cardiac rehabilitation program without utilizing pedometer feedback.The control groups 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
Hospital Madani city Khorramabad
Full name of responsible person
Mostafa Cheraghi
Street address
Shaghayegh Square
City
Korramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 61 4466 7956
Email
Drcheraghi406@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Morrovat Taheri Kalani
Street address
Khorram Abad - Kamalundeh - Kilometer 4 Khorramabad Road, Boroujerd
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
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shahid Abdovali. Baghcheban, Cepah Boulvar
City
Kouhdasht
Province
Lorestan
Postal code
6841956586
Phone
+98 66 3263 0659
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
Sport Medicine
Street address
Shahid Abdvali, Bagcheban, Cepah Boulvar
City
Kouhdasht
Province
Lorestan
Postal code
6841956586
Phone
+98 66 3263 0659
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
Sport Medicine
Street address
Shahide Abdvali, Cepah Boulvar
City
Kouhdasht
Province
Lorestan
Postal code
6841956586
Phone
+98 66 3263 0659
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
No - There is not 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
2018
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
Comments
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