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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: High Intensity Exercise Training
* Behavioral: Moderate Intensity Exercise Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Exercise<br>High intensity resistance and aerobic training | Behavioral: High Intensity Exercise Training<br>* 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.<br>|
| Active Comparator: Moderate Intensity Exercise<br>Moderate intensity resistance and aerobic training | Behavioral: Moderate Intensity Exercise Training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength |  | Baseline and 3 months thereafter | 
| Physical Function |  | Baseline and 3 months thereafter | 
| Exercise Capacity |  | Baseline and 3 months thereafter |