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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00172536
First received: September 12, 2005
Last updated: April 21, 2011
Last verified: March 2011
  Purpose

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 Intervention
Diabetes Mellitus, Non-Insulin-Dependent
Coronary Arteriosclerosis
Post Coronary Artery Bypass Grafting
Behavioral: Exercise training
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Official Title: Effects of Exercise Training on Left Ventricular Function in Type 2 Diabetic Patients Post Coronary Artery Bypass Graft

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Exercise capacity [ Time Frame: Three months after the start of the intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Endothelial function [ Time Frame: Three months after the start of the intervention ] [ Designated as safety issue: No ]
    Examined by flow-mediated vasodilation

  • Hemodynamics [ Time Frame: Three times after the start of the intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Including fasting glucose, HbA1c, total cholesterol (TC), high-density liporpotein (HDL-c) and triglyceride (TG).


Enrollment: 65
Study Start Date: October 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Received oral general education about proper diet, regular physcial activity and other medical care if necessary
Other: Control
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00172536

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Study Director: Ying-Tai Wu, Doctor National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Ying-Tai Wu, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
ClinicalTrials.gov Identifier: NCT00172536     History of Changes
Other Study ID Numbers: 9361701147
Study First Received: September 12, 2005
Last Updated: April 21, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014