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Clinical Trials/NCT02473926
NCT02473926
Completed
Not Applicable

Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

University of Colorado, Denver1 site in 1 country55 target enrollmentDecember 2015
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ConditionsMotor ActivityHealth BehaviorDiabetes Mellitus, Type 2

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Motor Activity
Sponsor
University of Colorado, Denver
Enrollment
55
Locations
1
Primary Endpoint
Change From Baseline in Objective Physical Activity at 4 Months
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study plans to learn more about physical activity and physical function in sedentary older adults with type 2 diabetes.

Detailed Description

The purpose of this study is to conduct a randomized controlled trial with 1:1 patient-level randomization to an evidence-based physical activity program intervention versus usual care in sedentary older adults with type 2 diabetes in two primary care clinic sites.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
July 29, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Diagnosis of type 2 diabetes
  • •Sedentary individual, performing \<20 minutes of physical activity on \<3 days/week

Exclusion Criteria

  • •Dementia (Folstein Mini-Mental Status Exam \<24) or clinical diagnosis
  • •Excessive fall risk: Can not hold semi-tandem stance for \>10 seconds
  • •Type 2 diabetes-related safety concerns: Prior diabetic foot ulcer, Charcot foot, asymptomatic hypoglycemia
  • •Severely uncontrolled hypertension (BP \>180/100)
  • •Excessive hearing or visual impairment for counseling
  • •Limited life expectancy: Active treatment for malignancy
  • •Performs regular physical activity \>20 minutes on \>3 days/week

Outcomes

Primary Outcomes

Change From Baseline in Objective Physical Activity at 4 Months

Time Frame: Baseline, 4 Months

ActiGraph accelerometer measures physical activity objectively as steps/week. These data are presented as the change from baseline values.

Secondary Outcomes

  • Change From Baseline in Physical Function at 4 Months(Baseline, 4 Months)

Study Sites (1)

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