Protocol summary

Summary
Acute coronary syndrome is one of the major cardiovascular diseases that lead to a ‎significant ‎amount of morbidity and hospitalization. The purpose of the present study was to ‎investigate the ‎effect of cardiac rehabilitation on quality of life in patients with acute coronary ‎syndrome.‎ This was a clinical trial study on 50 patients with acute coronary ‎syndrome admitted to the coronary ‎care unit in 2013-2014 without chronic heart failure and uncontrolled hypertension. The ‎participants were randomly ‎assigned to two groups of control and experimental. The experimental ‎group ‎received cardiac rehabilitation program, however, the control group received routine care. ‎The ‎data was collected via a demographic questionnaire and sf-36 quality of life questioner before ‎and ‎after the intervention.‎ The results of this study may show that Cardiac rehabilitation program can lead to ‎improving the ‎quality of life in patients with acute coronary syndrome

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014061418075N2
Registration date: 2014-07-15, 1393/04/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-15, 1393/04/24
Registrant information
Name
Safura Dorri
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 236 1752
Email address
s_dorri@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-10-11, 1392/07/19
Expected recruitment end date
2014-03-19, 1392/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of a Cardiac Rehabilitation Program on Quality of Life in Acute Coronary Syndrome ‎Patients
Public title
The Effect of cardiac rehabilitation on quality of life in patients with acute coronary ‎syndrome ‎‏ ‏
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: The desire of patients; No history of chronic heart failure, Dementia, disability or ‎contraindications for exercise (such as ‎joint disease); No uncontrolled hypertension, Complete ‎Heart Block, uncontrolled dysrhythmia and ‎thrombophlebitis; No Any type of heart surgery; Allow ‎physicians to participate in rehabilitation programs. Exclusion criteria: Irregular participation in the ‎rehabilitation program
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
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
Isfahan University of Medical Sciences
Street address
Hezargarib street-Isfahan
City
Isfahan
Postal code
Approval date
2013-06-16, 1392/03/26
Ethics committee reference number
392403

Health conditions studied

1

Description of health condition studied
acute coronary syndrome
ICD-10 code
120.0-121-
ICD-10 code description
Unstable angina-Acute myocardial infarction-Subsequent myocardial infarction

Primary outcomes

1

Description
Quality of life
Timepoint
Before intervention- one month after intervention
Method of measurement
Sf-36 questioner

Secondary outcomes

empty

Intervention groups

1

Description
For intervention group: cardiac rehabilitation in phase 1 and 2 (hospitalization and one ‎month ‎after ‎discharge).‎ ‎ Interventions in phase 1 include: education about safe activity for patient based ‎on ‎metabolic ‎equivalent rate and delivering the patient to very light activity level (maximum 3 ‎MET).‎ Interventions in phase 2 (to delivering the patient to moderate activity level or maximum 7 ‎MET) include: refer to hospital in the first and fourth weeks after ‎discharge to ‎do ‎electrocardiography, cardiologist visit, monitoring of blood pressure, heart rate, safe ‎walking, and heart monitoring ‎after walking.‎ In the second and third weeks after discharge, telephone follow-up was done and education ‎about safe activity, were given to the patients.‎
Category
Rehabilitation

2

Description
For control group: routine care in CCU ward in hospitalization time
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Lenjan hospital
Full name of responsible person
Safura Dorri
Street address
shohadaye Lenjan hospital, Zarrin Shahr
City
Zarrin Shahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Research unit of Isfahan University of Medical Sciences
Street address
Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Asghar khalife zadeh
Position
Department of Critical Care Nursing, School of Nursing and Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 2968
Fax
Email
khalifezadeh@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Asghar khalife zadeh
Position
MS of Nursing
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2968
Fax
Email
khalifezadeh@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dorri
Full name of responsible person
Safura
Position
MSc in Nursing Education, Department of Medical Surgical Nursing
Other areas of specialty/work
Street address
Isfahan
City
Postal code
Phone
00
Fax
Email
s_dorri86@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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