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Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

Not Applicable
Completed
Conditions
Motor Activity
Diabetes Mellitus, Type 2
Health Behavior
Interventions
Behavioral: Physical Activity
Behavioral: Questionnaires
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.

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
Arm && Interventions
GroupInterventionDescription
Physical Activity Program InterventionPhysical ActivityThe 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.
Usual Care GroupQuestionnairesParticipants 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.
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Objective Physical Activity at 4 MonthsBaseline, 4 Months

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

Secondary Outcome Measures
NameTimeMethod
Change From Baseline in Physical Function at 4 MonthsBaseline, 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

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