Protocol summary

Study aim
Determining the Effect of Early Movement Program on Arrhythmias in Patients with Acute Myocardial Infarction in Imam Khomeini Dehdasht Hospital in 2019
Design
Clinical trial with control group, with parallel groups, one blind, randomized
Settings and conduct
Patients with acute myocardial infarction diagnosed by a physician admitted to the CCU section of Imam Khomeini's Dehdasht hospital After obtaining written and informed consent from the subjects, the subjects will be randomly divided into two groups of intervention and control. The statistical analyzer has only information about raw data.
Participants/Inclusion and exclusion criteria
Arrival: Declaration of satisfaction regarding participation in research Diagnosis of acute myocardial infarction by a doctor He has had a heart attack for the first time LVEF> 35 Lack of heart disease underlying diseases No stable hemodynamic disorder Lack of dangerous arrhythmias such as Grade 2 and Grade 3 The absence of acute psychiatric disorders Motion disturbances in the extremities (disability or paralysis of the legs) Non-arrival conditions: Transfer to other departments or to another hospital Statement of dissatisfaction with participation in the research Patient death Problems with startup
Intervention groups
Patients with acute myocardial infarction hospitalized randomly in an early motion program 12 to 18 hours after bed rest in step-by-step steps in the 8 stages of the patient out of the bed and changes in the ECG and signs of the monitoring and recording Gets
Main outcome variables
heart of Arrhythmias

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190719044271N1
Registration date: 2020-01-04, 1398/10/14
Registration timing: retrospective

Last update: 2020-01-04, 1398/10/14
Update count: 0
Registration date
2020-01-04, 1398/10/14
Registrant information
Name
Nassiebe Janatifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3226 3292
Email address
janatinassiebe@smd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-27, 1398/01/07
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Early mobilization Program On the Generation of kind Arrhythmias of in Patients of Dehdasht Imam Khomeini Hospital with Acute Myocardial Infarction in 2019
Public title
The Effect of Early mobilization Program On the Generation of kind Arrhythmias of in Patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Declaration of satisfaction regarding participation in research Diagnosis of acute myocardial infarction by a doctor He has had a heart attack for the first time LVEF>35 Lack of heart disease underlying diseases No stable hemodynamic disorder Lack of dangerous arrhythmias such as Grade 2 and Grade 3 The absence of acute psychiatric disorders Motion disturbances in the extremities (disability or paralysis of the legs)
Exclusion criteria:
Transfer to other departments or to another hospital Statement of dissatisfaction with participation in the research Problems with startup Patient death
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the patients, the samples are returned to the intervention and control groups by means of a table of numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Statistical analyzer Who analyzes statistical information
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Najaf Abad Branch
Street address
University Boulevard, Islamic Azad University of Najaf Abad Branch
City
najafabad
Province
Isfehan
Postal code
7573171563
Approval date
2017-09-01, 1396/06/10
Ethics committee reference number
IR.IAU.FALA.REC.1398.040

Health conditions studied

1

Description of health condition studied
Acute Myocardial infarction
ICD-10 code
I23.8
ICD-10 code description
Other current complications following acute myocardial infarction

Primary outcomes

1

Description
The rate of cardiac arrhythmias in different stages of movement of patients with acute myocardial infarction in early movement program
Timepoint
َArrhythmias in the first stage of early movement 12 to 18 hours after acute myocardial infarction, at least three hours after the first stage, 24 hours after admission, at least three hours after the third stage, at least three hours after the fourth stage, 48 hours after admission, at least three hours after the sixth stage, at least three hours after the previous stage
Method of measurement
Cardiac monitoring, ECG, checklist

Secondary outcomes

1

Description
Control of the patient's vital signs
Timepoint
Before moving early, during moving, after moving
Method of measurement
Barometer

Intervention groups

1

Description
Intervention group: Patients with acute myocardial infarction who move on with the early movement program more than 18 hours after admission.
Category
Other

2

Description
Control group: Patients with acute myocardial infarction who come out of bed 48 hours after rest.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Dehdasht CCU Unit
Full name of responsible person
Nassiebeh Janatifard
Street address
Nursing Boulevard, Sepah Street
City
ِِِDehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7573171563
Phone
+98 74 3226 5901
Email
janatinassiebe@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Doctor Montazer Alghaem
Street address
University street, Islamic Azad University of Najaf Abad Branch
City
najafabad
Province
Isfehan
Postal code
7573171563
Phone
+98 31 4229 1111
Email
janatinassiebe@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic 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
Fatemeh Salmani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University street, Islamic Azad University of Najaf Abad Branch
City
Najaf Abad
Province
Isfehan
Postal code
1111111111
Phone
+98 31 4229 2581
Email
Ft_salmani@yahoo.com.au

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
fatemeh salmani
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University street, Islamic Azad University of Najaf Abad Branch
City
Najaf Abad
Province
Isfehan
Postal code
1111111111
Phone
+98 31 4229 2207
Email
ft_salmani@yahoo.com.au

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nassiebe Janati Fard
Position
master of nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Hospital, Nursing Boulevard, Sepah Pasdaran Ave.
City
Dehdasht
Province
Isfehan
Postal code
7573171563
Phone
+98 74 3226 5904
Email
janatinassiebeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be 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
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
The data from the study will be published as an article.
When the data will become available and for how long
6 to 12 months
To whom data/document is available
Everyone in the field of medicine and nursing
Under which criteria data/document could be used
People who study acute myocardial infarction patients.
From where data/document is obtainable
Email to the person in charge of the project
What processes are involved for a request to access data/document
Email to Applicant - Request from University Research Assistant - If the information is positive to the Providing information to the applicant
Comments
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