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NCT Number: NCT01417845

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Arkansas

Conway, Arkansas, 72035, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Exercise Training

Behavioral
  • 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.

Moderate Intensity Exercise Training

Behavioral
  • 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.

Primary outcomes

  1. Muscle Strength

    Time frame: Baseline and 3 months thereafter

  2. Physical Function

    Time frame: Baseline and 3 months thereafter

  3. Exercise Capacity

    Time frame: Baseline and 3 months thereafter

Sponsors and collaborators

Lead sponsor

University of Central Arkansas

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
First posted
Aug 16, 2011
Registry last updated
Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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