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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417845
• Other study ID #: UCA-IRB-11-077
• Status: Completed
• Phase: N/A
• First received: August 11, 2011
• Last updated: January 31, 2014
• Start date: September 2011

Study information

• Verified date: January 2014
• Source: University of Central Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Central Arkansas	Conway	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Strength		Baseline and 3 months thereafter	No
Primary	Physical Function		Baseline and 3 months thereafter	No
Primary	Exercise Capacity		Baseline and 3 months thereafter	No