The aim of this study is to compare the combined exercise time on lipid profile and total antioxidant capacity among cardiovascular patients.
Design
Clinical trials with control group, parallel group design, Not blinded, Not randomized
Settings and conduct
The population under study is a coronary artery bypass graft that has a positive exercise test and is present at the heart rehabilitation department of Afshar Hospital in Yazd. Patients will be excluded during the study if they do not want to participate in the study or develop any cardiovascular disease or skeletal problem. Individuals will be randomly divided into two groups, including a group that will receive cardiac rehabilitation and drug treatment and a control group that only will receive drug treatment. In each group, 10 people will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Coronary artery bypass graft surgery, low risk and Ejection fraction of 30%. Non inclusion criteria: unstable angina, uncorrected heart failure, cardiac infarction over the past four weeks, ventricular arrhythmias.
Intervention groups
Intervention group: 8 weeks of cardiac rehabilitation (aerobic exercise and resistance training) consisting of 3 sessions per week with an intensity of 50-80% of heart rate reserve or Borg 11-13 depending on subjects' strength and resistance training.The training course along with the usual treatment of heart disease risk factors will include hyperlipidemia and high blood pressure. Exercises will follow the overload principle.
Control group: Those who do not participate in the rehabilitation program despite the physician's recommendation and their usual treatment of heart disease risk factors, including hyperlipidemia and high blood pressure.
Main outcome variables
The lipid profile and total antioxidant capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190529043755N2
Registration date:2019-08-10, 1398/05/19
Registration timing:retrospective
Last update:2019-08-10, 1398/05/19
Update count:0
Registration date
2019-08-10, 1398/05/19
Registrant information
Name
Mohammad Marandi
Name of organization / entity
University of Esfahan
Country
Iran (Islamic Republic of)
Phone
+98 35 3522 8570
Email address
s.mmarandi@spr.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
2018-01-10, 1396/10/20
Actual recruitment end date
2018-11-14, 1397/08/23
Trial completion date
2018-11-14, 1397/08/23
Scientific title
Evaluation of the effect of combined exercise on lipid profile and total antioxidant among cardiovascular patients
Public title
The effect of combined exercise on lipid profile and total antioxidant among cardiovascular patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients after Coronary Artery Bypass Graft Surgery
Surgical Injection site restoration
Having a low risk and ejection fraction of 30%
Exclusion criteria:
Not compensated heart failure
Unstable angina
Myocardial infarction over the past four weeks
Ventricular arrhythmia
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Not randomized
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 Yazd Shahid Sadoughi University of Medical Sciences
Street address
Central organization of Medical Sciences and Health Services, Shahid Dr.Bahonar Squre
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-12-15, 1396/09/24
Ethics committee reference number
IR.SSU.REC.1396.108
Health conditions studied
1
Description of health condition studied
Patients after Coronary Artery Bypass Graft Surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Serum Total antioxidant capacity
Timepoint
Before the start of the study , 4 and 8 weeks after the intervention
Method of measurement
Spectrophotometery
2
Description
Serum level of Lipid profile
Timepoint
Before the start of the study , 4 and 8 weeks after the intervention
Method of measurement
Chemical methode
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8 weeks cardiac rehabilitation (aerobic exercises and resistance training) included 3 sessions per week with an intensity of 50-80% of the heart rate reserve or the criterion of Borg 11-13 depending on the ability of the subjects and for each session up to 90 minutes as follows:Walking on the treadmill 20 to 30 minutes, the pedal on the fixed bike 10 to 12 minutes, the use of a handheld meter is 10 minutes and the resistance training consists of three repetitive sets, three movements for upper limbs and two lower extremity movements. Training course with the usual treatment of cardiac risk factors will include high hyperlipidemia and hypertension. The exercises will be carried out by observing the principle of overload.
Category
Rehabilitation
2
Description
Control group: Those who do not participate in the rehabilitation program despite their doctor's recommendation and the usual treatment of heart disease risk factors include hyperlipidemia and hypertension.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Heart Rehabilitation
Full name of responsible person
Mohammad Reza Vafaei Nsab
Street address
Afshar Hospital in Yazd, Jomhoori Eslami Bolevard
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3525 8354
Email
afsharhospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Isfahan University
Full name of responsible person
Masoud Roknizadeh
Street address
The University of Isfahan, Daneshgah blvd
City
Isfahan
Province
Isfehan
Postal code
81746-37441
Phone
+98 31 3793 2171
Email
rokni@sci.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Isfahan University
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
The University of Isfahan
Full name of responsible person
Mohammad Marandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
The University of Isfahan, Daneshgah blvd
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 2640
Email
smmarandi2001@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Mohammad Marandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
The University of Isfahan, Daneshgah blvd
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 2640
Email
smmarandi2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Mohammd Marandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
The University of Isfahan, Daneshgah blvd
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 2640
Email
smmarandi2001@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of some patients' information and their dissatisfaction with the publication