The purpose of this study will be investigation and comparison of different exercise training program on rehabilitation of cardiac disease with coronary artery bypass graft operation (CABG). The study design will be base on double blind. Ninety patient post CABG surgery will be divided equally into three groups: continuous and periodic exercises 1 and 2. Inclusion criteria: left ventricular ejection fraction ≥50%, sinus rhythm and 4-16 week after CABG surgery; Exclusion criteria: peripheral vascular disease, valvular disease, atrial or ventricular premature beats, conduction defects, orthopedic or neurological limitation associated with exercise cessation of drug use during the study. Protocol of continues training ( 3 session per week, 45 minutes at 70 % reserve heart rate), high intensity interval -1 ( 5 ×4 minutes at 85-90% reserve heart rate and 3 minute interval at 60-70% reserve heart rate) and high intensity interval -2 ( 9×2 minutes at 85-90% reserve heart rate and 2 minute interval at 60-70% reserve heart rate) will be undertaken for 6 weeks. Indicators of rest and maximal heart rate, heart rate variability and quality of life will be measured before and after the 6 week training program.
General information
Acronym
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IRCT registration information
IRCT registration number:IRCT2015070123002N1
Registration date:2016-01-09, 1394/10/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-09, 1394/10/19
Registrant information
Name
Alireza Ghardashi Afousi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8201 5031
Email address
ghardashi.a@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of continuous and short and long-term high interval training on rehabilitation of cardiovascular patients
Public title
Clinical trial: Comparison of the effects of continuous and short and long-term high interval training on rehabilitation of cardiovascular patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: sinus rhythm,left ventricular ejection fraction ≥50% and 4- 16 week after coronary artery bypass graft surgery; Exclusion criteria: coexisting valvular and/or peripheral vascular diseases, frequent atrial or ventricular premature beats, conduction defects, pericarditis, peripheral neuropathy, orthopedic or neurological limitations, cessation of drug use during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
After baseline measurement, using the online randomization (http://www.graphpad.com/quickcalcs/index.cfm) subjects randomized and stratified to 3 groups (high interval intensity training-1, 2 and continuous training)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comitee of Baqiyatallah University of Medical Sciences
Street address
Exercise Physiology Research Center, Research, Baqiyatallah University of Medical Sciences, Alley Nosrati, St Sheikh Bahai, Mulla sadra,Vanak Square, Tehran
City
Tehran
Postal code
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
IR.BMSU.REC.1394.40
Health conditions studied
1
Description of health condition studied
Cardiovascular disease post coronary artery bypass graft
ICD-10 code
I23
ICD-10 code description
Myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset
Primary outcomes
1
Description
Resting heart rate
Timepoint
Befor and after 6 week
Method of measurement
Polar beat heart rate
2
Description
Ejection fraction
Timepoint
Befor and after 6 week intervention
Method of measurement
2 dimentional echocardiography
3
Description
Maximal heart rate
Timepoint
Befor and after 6 week intervention
Method of measurement
Polar beat heart rate
4
Description
cardiad out put
Timepoint
Befor and after 6 week intervention
Method of measurement
2 dimentional echocardiography
5
Description
Rate product pressure
Timepoint
Befor and after 6 week of intervention
Method of measurement
2 dimentional echocardiography
6
Description
End-systolic diameter
Timepoint
Befor and after 6 week of intervention
Method of measurement
2 dimentional echocardiography
7
Description
End-diastolic diameter
Timepoint
Befor and after 6 week of intervention
Method of measurement
2 dimentional echocardiography
8
Description
Stroke volume
Timepoint
Befor and after 6 week of intervention
Method of measurement
2 dimentional echocardiography
9
Description
Heart rate variabality
Timepoint
Befor and after 6 week of intervention
Method of measurement
Cardiac hollter monitoring
10
Description
Quality of life
Timepoint
Befor and after 6 week of intervention
Method of measurement
The World Health Organization Quality of Life Questionnaire
11
Description
Plasma glucose level
Timepoint
Befor and after 6 week of intervention
Method of measurement
Enzymatic
12
Description
Serum triglycerides
Timepoint
Befor and after 6 week intervention
Method of measurement
Photometry
13
Description
Serum cholestrol
Timepoint
Befor and after 6 week of intervention
Method of measurement
Photometry
14
Description
Serum LDL
Timepoint
Befor and after 6 week of intervention
Method of measurement
Photometry
15
Description
Serum HDL
Timepoint
Befor and after 6 week of intervention
Method of measurement
Photometry
16
Description
Blood pressure
Timepoint
Befor and after 6 week of intervention
Method of measurement
Barometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: moderate intensity contentious exercise (MICE) consist of 45 minutes at 70 % heart rate reserve, 3 session per week for 6 week. Warm- up and cool- down for patients at the start and end of each training session is at 50-55% heart rate reserve.
Category
Rehabilitation
2
Description
Intervention group 2: high intensity interval training-1 consist of: warm up 5 minutes at 50-55% heart rate reserve, and 5×4 minutes at 85-90% heart rate reserve and 3 minutes active period interval at 60-70% heart rate reserve, and the end of session of training cool down is 5 minutes at 50-55% heart rate reserve.
Category
Rehabilitation
3
Description
Intervention group 3 : high intensity interval training-2 consist of: warm up 5 minutes at 50-55% heart rate reserve, and 9×2 minutes at 85-90% heart rate reserve and 3 minutes active period interval at 60-70% heart rate reserve, and the end of session of training cool down is 5 minutes at 50-55% heart rate reserve.
Category
Rehabilitation
4
Description
Control group: No any exercise training program and maintain daily activities
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences
Full name of responsible person
bahram pishgoo MD, Mohammad Taghi Holisaz MD
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Alireza Ghardashi Afousi
Street address
Exercise physiology research center, research, University of Medical Sciences of Baqiyatallah, Alley shahid nosrati, Street Shikh bahaei, Molla sadra, Vanak Square
City
Tehran
Grant name
--
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Alireza Ghardashi Afousi
Position
Ph.D condidate
Other areas of specialty/work
Street address
Research Center for Exercise Physiology, Research, Baqiyatallahi University of Medical Sciences, Alley Nosrati, Sheikh Bahai, Street mula sadra, Vanak Square, Tehran
City
Tehran
Postal code
19395-5487
Phone
+98 21 8248 2402
Fax
Email
ghardashi.a@ut.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Alireza Ghardashi Afousi
Position
Ph.D condidate
Other areas of specialty/work
Street address
Research Center for Exercise Physiology, Research, Baqiyatallahi University of Medical Sciences, Alley Nosrati, Sheikh Bahai, Street mula sadra, Vanak Square, Tehran.
City
Tehran
Postal code
19395-5487
Phone
+98 21 8248 2402
Fax
Email
ghardashi.a@ut.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Alireza Ghardashi Afousi
Position
Ph.D condidate
Other areas of specialty/work
Street address
Research Center for Exercise Physiology, Research, Baqiyatallahi University of Medical Sciences, Alley Nosrati, Sheikh Bahai, Street mula sadra, Vanak Square, Tehran.
City
Tehran
Postal code
19395-5487
Phone
+98 21 8248 2402
Fax
+98 21 8860 0030
Email
ghardashi.a@ut.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)