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The Effect of Exercise Training Intensity in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417845
First Posted: August 16, 2011
Last Update Posted: February 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James David Taylor, PT, PhD, University of Central Arkansas
August 11, 2011
August 16, 2011
February 3, 2014
September 2011
August 2012   (Final data collection date for primary outcome measure)
  • Muscle Strength [ Time Frame: Baseline and 3 months thereafter ]
  • Physical Function [ Time Frame: Baseline and 3 months thereafter ]
  • Exercise Capacity [ Time Frame: Baseline and 3 months thereafter ]
  • Acute Exercise-Induced Glucose Changes [ Time Frame: Baseline, after about 45 minutes of exercise training, and 1 hour after about 45 minutes of exercise training ]
  • Physical Fitness [ Time Frame: Baseline and 3 months thereafter ]
  • Physical Function [ Time Frame: Baseline and 3 months thereafter ]
Complete list of historical versions of study NCT01417845 on ClinicalTrials.gov Archive Site
Not Provided
  • Adherence [ Time Frame: Baseline and 3 months thereafter ]
  • Adverse Events [ Time Frame: Baseline and 3 months thereafter ]
Not Provided
Not Provided
 
The Effect of Exercise Training Intensity in Patients With Type 2 Diabetes
The Effect of Moderate Versus High Intensity Exercise Training on Physical Fitness and Physical Function in Patients With Type 2 Diabetes: A Randomized Clinical Trial
The purpose of this randomized clinical trial is to compare the effect of moderate versus high intensity exercise training on physical fitness and physical function in patients with type 2 diabetes. The research hypothesis is that high intensity exercise training will be superior to moderate intensity on such outcomes in individuals with type 2 diabetes.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Type 2 Diabetes
  • Behavioral: High Intensity Exercise Training
    • High intensity resistance and aerobic training
    • Resistance training is performed 2 days per week for 3 months
    • Aerobic training is performed on the same days as resistance training and 1 additional day per week.
  • Behavioral: Moderate Intensity Exercise Training
    • Moderate intensity resistance and aerobic training
    • Resistance training is performed on 2 days per week for 3 months.
    • Aerobic training is performed on the same days as resistance training and 1 additional day per week.
  • Experimental: High Intensity Exercise
    High intensity resistance and aerobic training
    Intervention: Behavioral: High Intensity Exercise Training
  • Active Comparator: Moderate Intensity Exercise
    Moderate intensity resistance and aerobic training
    Intervention: Behavioral: Moderate Intensity Exercise Training
Taylor JD, Fletcher JP, Mathis RA, Cade WT. Effects of moderate- versus high-intensity exercise training on physical fitness and physical function in people with type 2 diabetes: a randomized clinical trial. Phys Ther. 2014 Dec;94(12):1720-30. doi: 10.2522/ptj.20140097. Epub 2014 Jul 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
Not Provided
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All participants meet the American Diabetes Association diagnostic criteria for type 2 diabetes.
  • A physician must consider each participant to be medically stable to participate in this investigation.

Exclusion Criteria:

  • Any individual with a history of a medical condition identified by the American Heart Association as an absolute contraindication to exercise testing is excluded from this study.
  • Any individual with angina (stable or unstable), uncontrolled hypertension, proliferative retinopathy, severe peripheral neuropathy, nephropathy, autonomic neuropathy, history of coronary artery disease, history of myocardial infarction, or unable to participate in this study due to a physical impairment is excluded from this investigation.
  • Any individual involved in resistance training or aerobic training within 3 months of the beginning of this investigation is excluded.
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01417845
UCA-IRB-11-077
No
Not Provided
Not Provided
James David Taylor, PT, PhD, University of Central Arkansas
University of Central Arkansas
Not Provided
Principal Investigator: James D Taylor, PhD, PT University of Central Arkansas
University of Central Arkansas
January 2014

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