Protocol summary
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Study aim
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The effect of periodic and continuous exercise on hemodynamic status, left ventricular function, lipid profiles, oxidative stress indices, knee proprioception, pain and quality of life after coronary artery bypass graft surgery
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Design
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Randomized clinical trial, parallel, controlled and double blinded
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Settings and conduct
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Continuing exercise group: this group will do sports less than 3 times a week. The amount of sport in each session will increase compared to the previous session. There will be a variety of sports in this group and the duration of the course will be at least six months per person.
Periodic exercise group: this group will use treadmills and fixed bikes every day from half an hour to one hour. It will be three times a week and every half an hour to one hour.
Control group: This group will not do any kind of sports.
The location of the study will be in Shahid Madani Hospital in Tabriz.
Physician, researcher and data analyst will be blind to the study.
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Participants/Inclusion and exclusion criteria
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Entry requirements: coronary artery graft surgery; ability to do sports.
Exit conditions: defects in the organs.
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Intervention groups
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Continuing exercise group: this group will do sports less than 3 times a week. The amount of sport in each session will increase compared to the previous session. There will be a variety of sports in this group and the duration of the course will be at least six months per person.
Periodic exercise group: this group will use treadmills and fixed bikes every day from half an hour to one hour. It will be three times a week and every half an hour to one hour.
Control group: this group will not do any kind of sports.
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Main outcome variables
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Hemodynamic status؛ Heart rate; ejection fraction; blood pressure; pain; stress; depression; quality of life; lipid profile; oxidative stress indices
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190325043107N2
Registration date:
2019-04-19, 1398/01/30
Registration timing:
prospective
Last update:
2019-09-25, 1398/07/03
Update count:
1
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Registration date
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2019-04-19, 1398/01/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-05, 1398/02/15
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Expected recruitment end date
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2020-03-05, 1398/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of periodic and continuous exercise on hemodynamic status left ventricular function, lipid profiles, oxidative stress indices, knee proprioception, pain and quality of life after coronary artery bypass graft surgery
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Public title
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The effect of periodic and continuous exercise on general performance of patients after coronary artery bypass graft surgery
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Perform coronary artery bypass surgery
Ability to do sports
Exclusion criteria:
Organ defects
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
300
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be divided into two groups using random numbers
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients will be in different groups. The researcher's assistance will intervene. During the intervention, the investigator, physician and data analyst will not be present and will not be aware of the type of grouping. By doing so, these people will be blind to the study.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-03-11, 1397/12/20
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Ethics committee reference number
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IR.TBZMED.REC.1397.1059
Health conditions studied
1
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Description of health condition studied
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Quality of Life
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Pain
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ICD-10 code
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R52.1
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ICD-10 code description
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Chronic intractable pain
Primary outcomes
1
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Description
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Ejection fraction
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Timepoint
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Weekly for to two months
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Method of measurement
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Ecocardiography
2
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Description
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Pain
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Timepoint
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Weekly for to two months
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Method of measurement
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VAS checklist
3
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Description
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Quality of Life
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Timepoint
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Monthly for to six months
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Method of measurement
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Quality of life questionnaire sf_36
4
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Description
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Oxidative stress indices
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Timepoint
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Daily for to two months
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Method of measurement
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Serum level of OHdG-8
5
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Description
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Heart reat
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Timepoint
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Daily
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Method of measurement
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Examination
6
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Description
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Blood pressure
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Timepoint
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Daily
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Method of measurement
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With the help of digital barometer
7
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Description
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Stress
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Timepoint
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Monthly
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Method of measurement
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Beck questionnaire
8
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Description
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Depression
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Timepoint
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Monthly
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Method of measurement
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Beck questionnaire
9
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Description
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Lipid profile
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Timepoint
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Monthly
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Method of measurement
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Blood test
10
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Description
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Indicators of oxidative stress
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Timepoint
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Monthly
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Method of measurement
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Blood test
Intervention groups
1
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Description
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First Intervention group: continuing exercise group: This group will do sports less than 3 times a week. The amount of sport in each session will increase compared to the previous session. There will be a variety of sports in this group and the duration of the course will be at least six months per person.
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Category
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Prevention
2
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Description
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Second Intervention group: Periodic exercise group: This group will use treadmills and fixed bikes every day from half an hour to one hour. It will be three times a week and every half an hour to one hour.
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Category
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Prevention
3
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Description
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Control group: This group will not do any kind of sports.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available