The effect of periodic and continuous exercise on left ventricular function, lipid profiles, oxidative stress indices, knee proprioception, pain and quality of life after coronary artery bypass graft surgery
The effect of periodic and continuous exercise on left ventricular function, lipid profiles, oxidative stress indices, knee proprioception, pain and quality of life after coronary artery bypass graft surgery
Design
Randomized clinical trial, parallel, controlled and double blinded
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Entry requirements: coronary artery graft surgery; ability to do sports.
Exit conditions: defects in the organs.
Intervention groups
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.
Main outcome variables
Heart rate; ejection fraction; blood pressure; pain; stress; depression; quality of life; lipid profile; oxidative stress indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N2
Registration date:2019-04-19, 1398/01/30
Registration timing:prospective
Last update:2019-04-19, 1398/01/30
Update count:1
Registration date
2019-04-19, 1398/01/30
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of periodic and continuous exercise on left ventricular function, lipid profiles, oxidative stress indices, knee proprioception, pain and quality of life after coronary artery bypass graft surgery
Public title
The effect of periodic and continuous exercise on general performance of patients after coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Perform coronary artery bypass surgery
Ability to do sports
Exclusion criteria:
Organ defects
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups using random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1059
Health conditions studied
1
Description of health condition studied
Quality of Life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Ejection fraction
Timepoint
Weekly for to two months
Method of measurement
Ecocardiography
2
Description
Pain
Timepoint
Weekly for to two months
Method of measurement
VAS checklist
3
Description
Quality of Life
Timepoint
Monthly for to six months
Method of measurement
Quality of life questionnaire sf_36
4
Description
Oxidative stress indices
Timepoint
Daily for to two months
Method of measurement
Serum level of OHdG-8
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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.
Category
Prevention
3
Description
Control group: This group will not do any kind of sports.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Mehdi Khanbabayi Gol
Street address
Azadi Ave, Shahid Madani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Shahid Madani Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available