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The effect of Cardiac rehabilitation educational program on risk factors and functional capacity of patients with coronary artery disease in Ali ibn abitaleb hospital, Zahedan, 1397

Protocol summary

Study aim
Determining the effect of cardiac rehabilitation program on risk factors and functional capacity of patients with coronary artery disease
Design
Semi-experimental study with control group on patients with coronary artery disease admitted to CCU units, Parallel groups, available sampling method, weekly coin thrown to determination control or intervention week . The sample size is 35 in each group.
Settings and conduct
Patients with coronary artery disease admitted to CCU of Ali ibn Abitalib hospital in Zahedan
Participants/Inclusion and exclusion criteria
Diagnosis of coronary artery disease is done by a specialist, confirming the results of diagnostic tests ;The first hospital admission is due to coronary artery disease; Ejection fraction is between 25 to 40%; The hemodynamic status at the start of the rehabilitation program is stable; Age between 25 and 65 years old; Ability to walk without help; Reside in Zahedan City There is no serious arrhythmia when the rehab program starts; Have not COPD, pulmonary artery pressure and right heart problems; Lack of history of heart surgery and not being a candidate for CABG
Intervention groups
For the intervention group, four sessions are scheduled at the time of discharge: 1st, 2nd, and 3rd weeks after that. The content of the sessions include the benefits of walking in reducing risk factors, the importance of cardiac rehab and treatment follow-up, training Risk factors, diet and management education, lifestyle changes. In every training session, checklists are monitored and evaluated . During the sixth, eighth and tenth weeks after the discharge, a phone call will be made to patients to check the patient's compliance with the activity schedules. The control group will receive only routine hospital training at the time of discharge.
Main outcome variables
Blood glucose, Blood lipid profile, Functional capacity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180110038298N2
Registration date: 2018-08-01, 1397/05/10
Registration timing: prospective

Last update: 2018-08-01, 1397/05/10
Update count: 0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Morteza Barani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
m.barani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-03, 1397/05/12
Expected recruitment end date
2018-12-03, 1397/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cardiac rehabilitation educational program on risk factors and functional capacity of patients with coronary artery disease in Ali ibn abitaleb hospital, Zahedan, 1397
Public title
The effect of Cardiac rehabilitation educational program on risk factors and functional capacity of patients with coronary artery disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of coronary artery disease is done by a specialist, confirming the results of diagnostic tests The first hospital admission is due to coronary artery disease Ejection fraction is between 25 to 40% The hemodynamic status at the start of the rehabilitation program is stable Age between 25 and 65 years old Ability to walk without help Reside in Zahedan City
Exclusion criteria:
There is no serious arrhythmia when the rehab program starts Have not COPD, pulmonary artery pressure and right heart problems Lack of history of heart surgery and not being a candidate for CABG
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
More than 1 sample in each individual
Number of samples in each individual: 2
Initially and before the start of the program, a blood sample for fat profile and suger are obtained and then compared at the end of the intervention by re-sampling.
Randomization (investigator's opinion)
Not randomized
Randomization description
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 committee of zahedan university of medical Sciences
Street address
NO. 1 , Daneshgah Ave., Hesabi Squ., Pardis complex , university of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR.ZAUMS.REC.1397.125

Health conditions studied

1

Description of health condition studied
Cardiovascular disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Cardiac Rehabilitation educational Program
Timepoint
Before discharge and then the end of the study in the twelfth week
Method of measurement
blood sample, 6 minute walk test

Secondary outcomes

1

Description
Blood glucose
Timepoint
Before discharge and then the end of the study in the twelfth week
Method of measurement
blood sample

2

Description
Blood lipid profile
Timepoint
Before discharge and then the end of the study in the twelfth week
Method of measurement
blood sample

3

Description
Waist Circumference
Timepoint
Before discharge and then the end of the study in the twelfth week
Method of measurement
Measuring with meter

4

Description
Waist–hip ratio
Timepoint
Before discharge and then the end of the study in the twelfth week
Method of measurement
The number obtained by dividing the waist circumference of the hip circumference

5

Description
6 minute walk test
Timepoint
Before discharge and then the end of the study in the twelfth week
Method of measurement
The distance traveled in a six minute walk test per meter

Intervention groups

1

Description
Intervention group: Includes 35 patients undergoing a cardiac rehabilitation program within twelve weeks. The program consists of four lecture sessions and a questionnaire that focuses on the risk factors for cardiovascular disease including blood sugar and lipids, and hypertension, which, prior to discharge, are dispensed in the first week after discharge. The second and third weeks are held. In addition, the patient follows a daily walking program at least three times a week during the study period, which increases the heart rate by 10% on a weekly basis. Before the intervention, and at the end of the twelfth week blood tests are performed, including blood sugar and blood lipids. Blood pressure, waist circumference and waist to hip ratio and distance traveled in the six-minute walk test are compared at the beginning and end of the study.
Category
Rehabilitation

2

Description
Control group: Includes 35 eligible patients who receive routine hospital training. Blood glucose and blood tests are done prior to discharge and at the end of the study. Record the blood pressure and distance traveled in the 6-minute walk test at the time of discharge and in the 12th week and compare with the intervention group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali ibn Abitaleb Zahedan Hospital
Full name of responsible person
Mohammad Kazem Moemeni
Street address
No. 1, Persian Gulf Highway, Blvd.Salamat, Ali Ibn Abi Talib haospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
alihos_zah@yahoo.com
Web page address
http://alihos.zaums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noormohammad Bakhshai
Street address
No. 1, NO. 1 , Daneshgah Ave., Hesabi Squ., Pardis complex , University of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3341 6708
Email
public@zaums.ac.ir
Web page address
http://www.zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Azam Shabazi Dehsookhte
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Behdasht Blvd.,Mashahir square, Faculty of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Email
shahbazi.azam92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fariba Yaghubi Nia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 1, Behdasht Blvd.,Mashahir square, Faculty of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3343 0059
Fax
+98 54 3344 2481
Email
yaghoubinia@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Azam Shabazi Dehsookhte
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Behdasht Blvd.,Mashahir square, Faculty of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Email
shahbazi.azam92@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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