Comparison of Hospital-Based Rehabilitation Versus Home-Based Exercise Training in Patients After Coronary Artery Bypass Grafting(CABG): Effects on Functional Capacity, Quality of Life, Psychological Symptoms, and Hemodynamic Parameters
Main goal of our study is comparing hospital-based rehabilitation versus home-based exercise training in patients after CABG to compare whether they have differences in exercise tolerance test, echocardiographic indices and quality of life, by comparing maximum heart rate with rest time, changes in systolic and diastolic pressures, evaluate the 6-minute walk test score, ejection fraction (EF) , diastolic indicators to evaluate the performance of the ventricles, comparing the rate pressure product (RPP), quality of life and score of depression at end of rehabilitation program between both groups. Mentioned items assess in all 3 study groups. Patients who have history of CABG in previous 4 to 8 weeks and Stroke volume, more than 40 percent without history of unstable angina are eligible for our study. All patients give recommendation of receiving rehabilitation services in rehabilitation center of Tehran Heart Center. Those who accept the recommendations, will be in group 1, patient that could not receive rehabilitation services from Tehran Heart Center but accept take part in home-based program will be in group 2 and those not accept rehabilitation program will constitute in group 3(control group). At the end of 12 weeks rate of changes in mention indices will be measure
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017013132290N2
Registration date:2017-07-25, 1396/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-25, 1396/05/03
Registrant information
Name
Ali Vasheghani Farahani
Name of organization / entity
Cardiologist Of Tehran Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6405 3481
Email address
medicalfrd@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of research, Tehran University of Medical Sciences
Expected recruitment start date
2017-07-11, 1396/04/20
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Hospital-Based Rehabilitation Versus Home-Based Exercise Training in Patients After Coronary Artery Bypass Grafting(CABG): Effects on Functional Capacity, Quality of Life, Psychological Symptoms, and Hemodynamic Parameters
Public title
Cardiac Rehabilitation In Coronary Artery Bypass Grafting (CABG) Patients
Purpose
Supportive
Inclusion/Exclusion criteria
“Inclusion criteria”:
• stroke volume more than 40%
• Coronary artery bypasses surgery recently in previous 4 to 8 weeks
• Having a normal response to exercise test
“Exclusion criteria”:
• ventricular arrhythmias
• atrial fibrillation
• uncontrolled hypertension
• type 2 diabetes
• systemic disease and pulmonary that limited Sports
• physical disabilities and any conditions limited Sports
• severe valvular heart disease
• known or suspected aortic dissection
Age
From 35 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
93
Randomization (investigator's opinion)
N/A
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 Tehran University of Medical Sciences
Street address
Headquarters Building of Tehran University of Medical Sciences , Keshavarz "Blvd"
City
Tehran
Postal code
Approval date
2016-12-19, 1395/09/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1261
Health conditions studied
1
Description of health condition studied
Patient with Coronary Artery Bypass Grafting Surgery
ICD-10 code
121-122-12
ICD-10 code description
121-Acute myocardial infarction 122-Subsequent myocardial infarction 123-Certain current complications following acute myocardial infarction 125-Chronic ischaemic heart disease
Primary outcomes
1
Description
Score in Six minute walk test (MWT)
Timepoint
8 weeks after starting intervention
Method of measurement
Pedometr
2
Description
Rate Pressure Product
Timepoint
12 Weeks after starting intervention
Method of measurement
Exercise Test
3
Description
Ejecton Fraction (EF)
Timepoint
Based and 12 weeks later
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Quality Of Life
Timepoint
Base and 12 weeks later
Method of measurement
Questionnaire
2
Description
Tei index
Timepoint
12 weeks after intervention
Method of measurement
Echocardiography
3
Description
Depression
Timepoint
Base and 12 weeks later
Method of measurement
Questionnaire
4
Description
Systolic and Diastolic Blood Pressure
Timepoint
At base and 12 weeks after intervention
Method of measurement
Sphygmanimeter
Intervention groups
1
Description
Second group will receive rehabilitation at home, take exercise program after being discharged from hospital, advised to exercise orderly and call doctor when having a problem. In order to motivate this group they will receive periodic telephone calls.
A pedometer device will give them to measure the amount of their activity objectively. An educated nurse will call them weekly and ask them about calorie intake and walking distance which measured by pedometer
Category
Rehabilitation
2
Description
The study included two intervention groups and one control group. The first intervention group received hospital-based usual rehabilitation program from rehabilitation center of Tehran Heart Center
Category
Rehabilitation
3
Description
The control group with the same schedule as group 2 will be followed up by phone. For Ethical principles, we will advise control group to received rehabilitation program from rehabilitation center of Tehran Heart Center or having regular physical activity at homes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Ali Vasheghani Farahani
Street address
Cardiac Rehabilitation center of Tehran Heart Center,North Kargar
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of research,Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Floor 6, Official Building of Tehran University of Medical Sciences, Corner of Qods
City
Tehran
Grant name
Grant code / Reference number
95-01-30-30148
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of research,Tehran 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
Tehran Heart Center
Full name of responsible person
Negar Omidi
Position
Faculty Member of Cardiology Department
Other areas of specialty/work
Street address
Floor 2, Research Center Building,Tehran Heart Center, North Kargar "St"
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
negar.omidi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Negar Omidi
Position
Cardiologist
Other areas of specialty/work
Street address
Floor 2, Research Center Building,Tehran Heart Center,North karegar
City
Tehran
Postal code
Phone
+98 912 225 6314
Fax
Email
negar.omidi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Negar Omidi
Position
Faculty Member of Cardiology Department
Other areas of specialty/work
Street address
Floor 2, Research Center Building, Tehran Heart Center, North Karegar
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)