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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
  Purpose
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.

Condition Intervention
Type 2 Diabetes Behavioral: High Intensity Exercise Training Behavioral: Moderate Intensity Exercise Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by James David Taylor, PT, PhD, University of Central Arkansas:

Primary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: September 2011
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity Exercise
High intensity resistance and aerobic training
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.
Active Comparator: Moderate Intensity Exercise
Moderate intensity resistance and aerobic training
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417845


Locations
United States, Arkansas
University of Central Arkansas
Conway, Arkansas, United States, 72035
Sponsors and Collaborators
University of Central Arkansas
Investigators
Principal Investigator: James D Taylor, PhD, PT University of Central Arkansas
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James David Taylor, PT, PhD, Associate Professor of Physical Therapy, University of Central Arkansas
ClinicalTrials.gov Identifier: NCT01417845     History of Changes
Other Study ID Numbers: UCA-IRB-11-077
First Submitted: August 11, 2011
First Posted: August 16, 2011
Last Update Posted: February 3, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases