Effects of Exercise Training on Left Ventricular Function in Type 2 Diabetic Patients Post Coronary Artery Bypass Graft

NCT ID: NCT00172536

Last Updated: 2011-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2006-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent; Coronary Arteriosclerosis; Post Coronary Artery Bypass Grafting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Control

Received oral general education about proper diet, regular physcial activity and other medical care if necessary

Group Type: OTHER

Control

Intervention Type: OTHER

Subjects received general education including proper diet, regular physical activity or medical care if necessary through an interview with a physical therapist.

Exercise training

Received a supervised structure treadmill training

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Control

Subjects received general education including proper diet, regular physical activity or medical care if necessary through an interview with a physical therapist.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• well-controlled diabetes
• no history of myocardial infarction
• stable post CABG for at least 3 months

Exclusion Criteria

• heart failure
• valvular disease
• abnormal kidney or liver function
• cerebrovascular disease
• primary pulmonary disease
• other systemic or acute illness that may impede the testing or training

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Principal Investigators

Ying-Tai Wu, Doctor

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

9361701147

Identifier Type: -

Identifier Source: org_study_id