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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James David Taylor, PT, PhD, University of Central Arkansas
ClinicalTrials.gov Identifier:
NCT01417845
First received: August 11, 2011
Last updated: January 31, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 University of Central Arkansas:

Primary Outcome Measures:
  • Muscle Strength [ Time Frame: Baseline and 3 months thereafter ] [ Designated as safety issue: No ]
  • Physical Function [ Time Frame: Baseline and 3 months thereafter ] [ Designated as safety issue: No ]
  • Exercise Capacity [ Time Frame: Baseline and 3 months thereafter ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 11, 2011
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014