Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

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

Detailed Description
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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.

Official Title
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Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

Conditions
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Motor Activity, Health Behavior, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Physical Activity
* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity Program Intervention<br>The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes. In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities. | Behavioral: Physical Activity<br>* Physical Activity Program Intervention<br>|
| Other: Usual Care Group<br>Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics. | Behavioral: Questionnaires<br>* Participants in the usual care arm will receive three mailings during the intervention phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 4 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Baseline, 4 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Physical Function, Physical Impairment, Sedentary Lifestyle