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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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18 June 2018 |
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Main ID: |
IRCT20120215009014N221 |
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Date of registration:
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2018-05-21 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of Resoratol supplementation with and without exercise rehabilitation training versus no intervention on inflammatory factors and lipid profile in cardiac patients undergoing coronary artery bypass graft surgery
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Scientific title:
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The effect of Resoratol supplementation with and without exercise rehabilitation training versus no intervention on inflammatory factors and lipid profile in cardiac patients undergoing coronary artery bypass graft surgery: a randomized clinical trial |
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Date of first enrolment:
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2016-10-22 |
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Target sample size:
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40 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/31217 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients to the intervention and control groups through the drawing of lots.
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Phase:
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2
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr Javad Almasi
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Address:
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Islamic Azad University, Hamadan Brunch, Imam Khomeini Ave.
6518115743
Hamadan
Iran (Islamic Republic of) |
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Telephone:
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+98 81 3448 1000 |
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Email:
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almasi.javad@yahoo.com |
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Affiliation:
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Islamic Azad University |
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Name:
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Dr Javad Almasi
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Address:
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Islamic Azad University, Hamadan Brunch, Imam Khomeini Ave.
6518115743
Hamadan
Iran (Islamic Republic of) |
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Telephone:
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+98 81 3838 1740 |
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Email:
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almasi.javad@yahoo.com |
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Affiliation:
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Islamic Azad University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age of 18 to 80 years
Cardiac patients undergoing coronary artery bypass graft surgery
Exclusion criteria: Cardiac angina during exercise testing
Age minimum:
18 years
Age maximum:
80 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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I25.70
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Cardiac patients undergoing coronary artery bypass graft surgery.
Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris
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Intervention(s)
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Intervention 1: Intervention group 1: Oral Resoratol supplementation daily for 3 months. Intervention 2: Intervention group 2: Physical activity consists of 5 to 10 minutes of warming and then endurance exercises including treadmill or working wheel for heart rehabilitation for 15 to 20 minutes with intensity of 50 to 70% 3 times a week for 3 months. Intervention 3: Intervention group 3: Oral Resoratol supplementation daily for 3 months plus physical activity consists of 5 to 10 minutes of warming and then endurance exercises including treadmill or working wheel for heart rehabilitation for 15 to 20 minutes with intensity of 50 to 70% 3 times a week for 3 months. Intervention 4: Control group: Without any intervention.
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Primary Outcome(s)
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Assessing lipid profile (LDL, HDL). Timepoint: Before intervention and 3 months after intervention. Method of measurement: Though laboratory testing.
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Assessing inflammatory factors (CRP, TNFa, Interlukin-6). Timepoint: Before intervention and 3 months after intervention. Method of measurement: Though laboratory testing.
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Source(s) of Monetary Support
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Islamic Azad University
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of Hamadan University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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