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OpenTrials
Completed

NCT Number: NCT02473926

Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

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

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Key information

Conditions

Motor Activity Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Sedentary Behavior

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver | Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

Physical Activity Program Intervention

Questionnaires

Behavioral

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

Primary outcomes

  1. 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

  1. Change From Baseline in Physical Function at 4 Months

    Time frame: Baseline, 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.

  2. Change From Baseline in Physical Function at 4 Months

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 17, 2015
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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