Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

University of Colorado, Denver55 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Motor Activity Health Behavior Diabetes Mellitus, Type 2

Interventions

Physical ActivityBEHAVIORAL

Physical Activity Program Intervention

QuestionnairesBEHAVIORAL

Participants in the usual care arm will receive three mailings during the intervention phase.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado Denver | Anschutz Medical Campus

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Change From Baseline in Objective Physical Activity at 4 Months

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

Time frame: Baseline, 4 Months

Secondary Outcomes

Change From Baseline in Physical Function at 4 Months

Measured via 400-meter rapid gait speed test. These data are presented as the change from baseline values, where decrease in numbers indicate a faster walking speed.

Time frame: Baseline, 4 Months

Change From Baseline in Physical Function at 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).

Time frame: Baseline, 4 Months

Data from ClinicalTrials.gov

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