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

NCT00172536 | Completed DMC

• 1 other identifier: 9361701147
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Exercise capacity

  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).

  Three months after the start of the intervention

• Diastolic heart function

  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.

  Three months after the start of the intervention

Secondary Outcomes (3)

• Endothelial function

  Three months after the start of the intervention

• Hemodynamics

  Three times after the start of the intervention

• Blood test

  Three months after the start of the intervention

Study Arms (2)

Control

OTHER

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

Other: Control

Exercise training

EXPERIMENTAL

Received a supervised structure treadmill training

Behavioral: Exercise training

Interventions

Exercise training 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.

Exercise training

Control OTHER

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

Control

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ying-Tai Wu, Doctor

  National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: April 22, 2011

Record last verified: 2011-03

Locations

TW (1)