Comparing the effects of 4 and 8 weeks Cardiac Rehabilitation exercise on Exercise Capacity, Anxiety, Depression and quality of life in High Risk Cardiac Patients post CABG.
Introduction: Cardiovascular disease is leading cause of mortality and morbidity in the world. Although the physiological and psychological benefits of exercise cardiac rehabilitation(CR) as main part of secondary prevention have been shown in low risk cardiac patients, there is lack of scientific evidence in high risk cardiac patients. The aim of present study was to investigate the effects of CR program on high risk cardiac patients in Iran.
Methods: 40 high risk cardiac patients (mean age 61.40± 6.09) who had coronary artery bypass grafting (CABG) participated in phase III exercise cardiac rehabilitation. Participants were randomly divided in two groups which one group completed 4 weeks CR while other group participated in 8 weeks CR program. All patients underwent symptom limited exercise testing using modified Bruce Protocol before and immediately after CR program. Participants also completed Hospital Anxiety and Depression scale (HADs) at baseline and end of CR program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042917456N2
Registration date:2014-08-22, 1393/05/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-22, 1393/05/31
Registrant information
Name
Azam Bashiri
Name of organization / entity
Tehran University
Country
Iran (Islamic Republic of)
Phone
+98 81 3833 7019
Email address
azam.bashiri@alumni.ut.ac.ir
Recruitment status
Recruitment complete
Funding source
University of bu_ali sina hamedan
Expected recruitment start date
2012-12-20, 1391/09/30
Expected recruitment end date
2013-08-21, 1392/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of 4 and 8 weeks Cardiac Rehabilitation exercise on Exercise Capacity, Anxiety, Depression and quality of life in High Risk Cardiac Patients post CABG.
Public title
Comparing the effects of 4 and 8 weeks Cardiac Rehabilitation exercise on Exercise Capacity, Anxiety, Depression and quality of life in High Risk Cardiac Patients post CABG.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age range of 50-70 years old; patients post CABG; patients hospitalized in Ekbatan hospital to be cardiac rehabilitated; high risk cardiac patients; patients agreed to participate in the research voluntarily.
Exclusion criteria: patients under 50 and upper 70 years old; low risk cardiac patients; patients being under treatment except doing CABG; patients not willing to participate in the research.
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran Univercity
Street address
Sport College, North Kargar st., Enghelab square
City
Tehran
Postal code
Approval date
2013-01-09, 1391/10/20
Ethics committee reference number
43728
Health conditions studied
1
Description of health condition studied
Cardiac exercise rehabilionitat
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Exercise capacity
Timepoint
At the first and in the end of rehabilitation period
Method of measurement
Participants did the exercise test ( corrected protocol of Bruss )
2
Description
Anxiety and depression
Timepoint
At the first and in the end of rehabilitation period
Method of measurement
HADS questionnaire
3
Description
Quality of life
Timepoint
At the first and in the end of rehabilitation period for two groups
Method of measurement
QLMI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Cardiac rehabilitation program for 4 weeks
Category
Rehabilitation
2
Description
Cardiac rehabilitation program for 8 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan hospital of Hamedan
Full name of responsible person
Azam Bashiri
Street address
Ekbatan hospital of Hamedan,taleghani street,hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University
Full name of responsible person
Dr Fazlolah Bagherzadeh
Street address
Sport College, North Kargar st., Enghelab square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University
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
Tehran University
Full name of responsible person
Reza Rajabi
Position
Professor in sport injery and correctiv exercise - Tehran university
Other areas of specialty/work
Street address
Sport College, North Kargar st., Enghelab square
City
Tehran
Postal code
Phone
+98 21 6695 5276
Fax
Email
rrajabi@ut.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University
Full name of responsible person
Azam Bashiri
Position
Master of science
Other areas of specialty/work
Street address
Sport College, North Kargar st., Enghelab square
City
Tehran
Postal code
Phone
+98 81 3264 0050
Fax
Email
azam.bashiri1@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university
Full name of responsible person
Azam Bashiri
Position
Master of science
Other areas of specialty/work
Street address
Anjiography departman, Besat haspital, Hamedan city, iran
City
Hamedan
Postal code
Phone
+98 81 3264 0050
Fax
Email
azam.bashiri1@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)