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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Exercise Training
Moderate Intensity Exercise Training
Sponsored by
University of Central Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Central Arkansas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Exercise

Moderate Intensity Exercise

Arm Description

High intensity resistance and aerobic training

Moderate intensity resistance and aerobic training

Outcomes

Primary Outcome Measures

Muscle Strength
Physical Function
Exercise Capacity

Secondary Outcome Measures

Full Information

First Posted
August 11, 2011
Last Updated
January 31, 2014
Sponsor
University of Central Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT01417845
Brief Title
The Effect of Exercise Training Intensity in Patients With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Exercise
Arm Type
Experimental
Arm Description
High intensity resistance and aerobic training
Arm Title
Moderate Intensity Exercise
Arm Type
Active Comparator
Arm Description
Moderate intensity resistance and aerobic training
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Exercise Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moderate Intensity Exercise Training
Intervention Description
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 Outcome Measure Information:
Title
Muscle Strength
Time Frame
Baseline and 3 months thereafter
Title
Physical Function
Time Frame
Baseline and 3 months thereafter
Title
Exercise Capacity
Time Frame
Baseline and 3 months thereafter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Taylor, PhD, PT
Organizational Affiliation
University of Central Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Central Arkansas
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72035
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25082918
Citation
Taylor JD, Fletcher JP, Mathis RA, Cade WT. Effects of moderate- versus high-intensity exercise training on physical fitness and physical function in people with type 2 diabetes: a randomized clinical trial. Phys Ther. 2014 Dec;94(12):1720-30. doi: 10.2522/ptj.20140097. Epub 2014 Jul 31.
Results Reference
derived

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

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