The aim of this study is to evaluate the effects of exercise training on patients with history of coronary artery bypass grafted surgery. Men aged 40-65 years who had this operation during past 3-12 months involved in study. Patients who had congestive heart failure (ejection fraction less than 40%); valvular heart disease; chronic renal disease and hepatic failure excluded from this study. Of 40 patients chosen to study, 20 men will be randomized to perform 6 weeks of exercise training using treadmill. Before and after completion of this period, flow-mediated dilation of brachial artery will be assessed and then would be compared with control group results.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204249555N1
Registration date:2012-05-08, 1391/02/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-08, 1391/02/19
Registrant information
Name
Ebrahim Hajizade
Name of organization / entity
Jundishapor University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 3538
Email address
hajizade.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Cardiovascular Research Center of Ahvaz Jundishapor University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of moderate aerobic exercise training on brachial artery flow-mediated dilatation in patients with coronary artery bypass graft surgery
Public title
Exercise training in post-CABG patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: post-CABG men; age 40 to 65 years;
Exclusion criteria: CABG in last 3 months; angioplasty in last 3 months; myocardial infarction in last 3 months; valvular heart disease; left ventricular ejection fraction < 40%; chronic obstructive pulmonary disease; chronic renal failure; liver failure; Patients who previously had moderate aerobic exercise as their routine physical activities.
Age
From 40 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
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
Ahvaz Jundishapor University of Medical Sciences
Street address
Golestan street
City
Ahvaz
Postal code
6135733118
Approval date
2011-06-15, 1390/03/25
Ethics committee reference number
Eth- 225
Health conditions studied
1
Description of health condition studied
effects of exercise training on endothelium-dependent dilation in patients with CABG history
ICD-10 code
Z50.0
ICD-10 code description
Cardiac Rehabilitation
Primary outcomes
1
Description
Flow mediated dilation of Brachial artery
Timepoint
before and after exercise training period
Method of measurement
Flow mediated dilation as an index of endothelium-dependent vasodilatation intended as percentage of increase in brachial artery diameter after deflating the cuff compared to its original size
Secondary outcomes
1
Description
Brachial artery internal diameter
Timepoint
before and after exercise training period
Method of measurement
brachial artery internal diameter mesured by doppler sonography
Intervention groups
1
Description
of all 40 patients intending in study, 20 cases will attend supervised aerobic moderate treadmill walking sessions(60-80% of the maximal heart rate predicted for the patient's age), three times a week. The sessions will continue for 6 weeks for each case. Before treadmill walking, 5 minutes of warm up including stretching exercises will perform for each subject. The treadmill walking starts using the Harbor treadmill protocol as follow: 3 minutes of relatively slow "warm-up" speed, followed by gradual increase in constant amount (1 to 4 percent per minute) for up to 10 minutes depending on the person’s fitness. The test will stop prior to achievement of the target heart rate if the patient develops significant chest discomfort, shortness of breath, dizziness, unsteady gait, or if the electrocardiogram shows alarming ischemic changes or serious arrhythmia's.All Patients (cases and controls) will asked to maintain their normal diet and other lifestyle behaviors, as well as their medications.
Assessments will then repeat for all 40 subjects, and crossover will occur with final assessments made 6 weeks after entry.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Research Center of Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Farzane Ahmadi M.D.cardiologist , master of echocardiography
Street address
Golestan street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cardiovascular Research Center of Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Farzane Ahmadi M.D.
Street address
Golestan street
City
Ahvaz
Grant name
U-90112
Grant code / Reference number
U-90112
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cardiovascular Research Center of Ahvaz Jundishapor University of Medical Sciences
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
Cardiovascular Research Center of Ahvaz Jundishapor University of Medical Sciences