Comparison the effects of home-based cardiac rehabilitation and routine care on patients’ quality of life after coronary artery bypass graft surgery
Design
In this research, 104 eligible patients underwent coronary artery bypass graft surgery in cardiac surgery units of Ahvaz Golestan and Emam Ghomaini hospitals will be chosen. Patients will be allocated to two equal groups of intervention and control according to table of random numbers.
Settings and conduct
This study will be conducted on cardiac surgery units of Ahvaz Golestan and Emam Ghomaini hospitals.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having 30-70 years old; having ejection fraction more than 40%; having systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 105 mmHg; having normal sinus rhythm; having full conciseness; being able to read and write.
Exclusion criteria: having history of stroke, end stage renal diseases, liver diseases, anemia, mental and nervous disorders, peripheral nervous system disorders, and uncontrolled diabetes; having delirium and dementia.
Intervention groups
In intervention group firstly patients will be divided to group of 2-3 individuals, and for each group in companion with their family members four educational sessions about home-based cardiac rehabilitation program with one hour duration and one day interval will be implemented by researcher in the recruitment hospitals. In the next stage, follow-up will be done at home and education will be presented again two times in each month for three months. In control group, patients will receive only routine care with no specific education. However, education will be presented to all patients in control group at the end of the study.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171114037468N1
Registration date:2017-12-28, 1396/10/07
Registration timing:registered_while_recruiting
Last update:2017-12-28, 1396/10/07
Update count:0
Registration date
2017-12-28, 1396/10/07
Registrant information
Name
kobra limooei
Name of organization / entity
ahwaz jundishapur universityof medical science
Country
Iran (Islamic Republic of)
Phone
+98 916 303 6731
Email address
limooei.k@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of home-based cardiac rehabilitation and routine care on patients’ quality of life after coronary artery bypass graft surgery
Public title
The effects of home-based cardiac rehabilitation on patients’ quality of life after coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having 30-70 years old
Having ejection fraction more than 40%
Having systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 105 mmHg
Having normal sinus rhythm
Having full conciseness
Being able to read and write
Exclusion criteria:
Having history of stroke, end stage renal diseases, liver diseases, anemia, mental and nervous disorders, peripheral nervous system disorders, and uncontrolled diabetes
Having delirium and dementia
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated to two equal groups of intervention and control according to table of random numbers.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
IR.AJUMS.REC.1396.548
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
T82.218D
ICD-10 code description
Other mechanical complication of coronary artery bypass graft, subsequent encounter
2
Description of health condition studied
Quality of life after cardiac surgery
ICD-10 code
I97.110
ICD-10 code description
Postprocedural cardiac insufficiency following cardiac surgery
Primary outcomes
1
Description
Quality of life
Timepoint
Before education, 6 weeks and 12 weeks after education
Method of measurement
Macnew quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group firstly patients will be divided to groups of 2-3 individuals, and for each groups in companion with their family members four educational sessions about home-based cardiac rehabilitation program with one hour duration and one day interval will be implemented by researcher in the recruitment hospitals. In the next stage, follow-up will be done at home and education will be presented again two times in each month for three months.
Category
Rehabilitation
2
Description
Control group: In control group, patients will receive only routine care with no specific education. However, education will be presented to all patients in control groups at the end of the study.