Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 12, 2005
April 21, 2011
October 2004
February 2006   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00172536 on ClinicalTrials.gov Archive Site
  • 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).
Not Provided
Not Provided
Not Provided
 
Effects of Exercise Training on Left Ventricular Function in Type 2 Diabetic Patients Post Coronary Artery Bypass Graft
Effects of Exercise Training on Left Ventricular Function in Type 2 Diabetic Patients Post Coronary Artery Bypass Graft

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Coronary Arteriosclerosis
  • Post Coronary Artery Bypass Grafting
  • 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.
  • Other: Control
    Subjects received general education including proper diet, regular physical activity or medical care if necessary through an interview with a physical therapist.
  • Control
    Received oral general education about proper diet, regular physcial activity and other medical care if necessary
    Intervention: Other: Control
  • Experimental: Exercise training
    Received a supervised structure treadmill training
    Intervention: Behavioral: Exercise training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
February 2006
February 2006   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00172536
9361701147
Yes
Ying-Tai Wu, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
National Taiwan University Hospital
National Science Council, Taiwan
Study Director: Ying-Tai Wu, Doctor National Taiwan University Hospital
National Taiwan University Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP