Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Motor Activity; Diabetes Mellitus, Type 2; Health Behavior

• Registration Number: NCT02473926
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-17
• Study Start: 2015-12
• Primary Completion: 2019-06
• Study Completion: 2019-07-29
• Results First Submitted: 2022-10-17
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Results First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Objective Physical Activity at 4 Months	Baseline, 4 Months	ActiGraph accelerometer measures physical activity objectively as steps/week. These data are presented as the change from baseline values.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Physical Function at 4 Months	Baseline, 4 Months	Measured via the Short Physical Performance Battery (SPPB), which evaluates balance, usual walking speed, and repeated chair rise. These data are presented as the change from baseline values where higher values indicate better physical function (scoring range 0-12).

Trial Locations

Locations (1)

University of Colorado Denver | Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States