Effects of Exercise Training on Left Ventricular Function in Type 2 Diabetic Patients Post Coronary Artery Bypass Graft
|ClinicalTrials.gov Identifier: NCT00172536|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 22, 2011
The purpose of this study is to investigate the changes of cardiorespiratory fitness and left ventricular function in type 2 diabetes after uncomplicated coronary artery bypass graft (CABG) surgery.
We hypothesize that exercise capacity, left ventricular diastolic function, and biochemical data improves after 12-wk exercise training in patients with type 2 diabetes underwent CABG.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Non-Insulin-Dependent Coronary Arteriosclerosis Post Coronary Artery Bypass Grafting||Behavioral: Exercise training Other: Control||Not Applicable|
Patients with type 2 diabetes mellitus have higher incidence of coronary artery disease or left ventricular dysfunction, particularly diastolic dysfunction. Coronary artery bypass surgery is known to decrease the mortality rate in diabetes. Further exercise training can improve their cardiorespiratory fitness and the control of risk factors in these patients. However, the extent of improvement and the mechanism, especially the changes in left ventricular function, in diabetes after exercise training have not been fully explored.
Subjects will be assigned to the intervention or control group by randomization. Subjects in the intervention group will receive 60% VO2 max moderate aerobic exercise training, twice per week under supervision and three times per week at home, for 12 weeks. All subjects receive left ventricular function test by echocardiography and impedance cardiography, graded maximal exercise test, and biochemical analyses of sugar and lipid before and after 12 weeks. Their dietary intake and physical activity will be inquired every 4 weeks by questionnaires.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Effects of Exercise Training on Left Ventricular Function in Type 2 Diabetic Patients Post Coronary Artery Bypass Graft|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||February 2006|
Received oral general education about proper diet, regular physcial activity and other medical care if necessary
Subjects received general education including proper diet, regular physical activity or medical care if necessary through an interview with a physical therapist.
Experimental: Exercise training
Received a supervised structure treadmill training
Behavioral: Exercise training
Subjects attended a supervised treadmill training session three times per week in an outpatient facility for three months. Training duration was 30 minutes per session, including a 5-minute warm-up and cool-down phase. Training intensity was initially set at about 60% of HR reserve and close to the anerobic threshold (AT) and the gradually increased as tolerated.
- Exercise capacity [ Time Frame: Three months after the start of the intervention ]Exercise capacity was assessed by peak oxygen uptake (VO2peak)via exercise testing. VO2peak was measured by a metabolic measurement system (Vmax229 Metabolic Measurement System, Sensor Medics, Anaheim, CA).
- Diastolic heart function [ Time Frame: Three months after the start of the intervention ]Echocardiographic examination including color B mode TDI with a commercially available 2.5- to 3.75-MHz phased array transducer (Philips, SONOS 5500, Andover, MA)was used to evaluate diastolic function.
- Endothelial function [ Time Frame: Three months after the start of the intervention ]Examined by flow-mediated vasodilation
- Hemodynamics [ Time Frame: Three times after the start of the intervention ]Heart rate (HR) and stroke volume (SV) were collected at rest, during the exercise test, and during the recovery phase by a noninvasive bioimpedance cardiograph device (PhysioFlow PF-05, Manatec Biomedical, Paris, France). Cardiac output (CO) and arteriovenous oxygen difference ((a-v)O2 difference) were then determined by the following equations: CO=HR*SV and (a-v)O2 difference=VO2/SV*HR
- Blood test [ Time Frame: Three months after the start of the intervention ]Including fasting glucose, HbA1c, total cholesterol (TC), high-density liporpotein (HDL-c) and triglyceride (TG).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00172536
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Study Director:||Ying-Tai Wu, Doctor||National Taiwan University Hospital|