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

January 31, 2014 updated by: James David Taylor, PT, PhD, University of Central Arkansas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Conway, Arkansas, United States, 72035
        • University of Central Arkansas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle Strength
Time Frame: Baseline and 3 months thereafter
Baseline and 3 months thereafter
Physical Function
Time Frame: Baseline and 3 months thereafter
Baseline and 3 months thereafter
Exercise Capacity
Time Frame: Baseline and 3 months thereafter
Baseline and 3 months thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Central Arkansas

Investigators

  • Principal Investigator: James D Taylor, PhD, PT, University of Central Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 11, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 16, 2011

Study Record Updates

Last Update Posted (Estimate)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCA-IRB-11-077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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