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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Motor Activity; Health Behavior
• Intervention / Treatment: Behavioral: Physical Activity; Behavioral: Questionnaires

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver | Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity Program Intervention; 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; Physical Activity Program Intervention
Other: Usual Care Group; 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; Participants in the usual care arm will receive three mailings during the intervention phase.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Amy Huebschmann, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• Huebschmann AG, Glasgow RE, Leavitt IM, Chapman K, Rice JD, Lockhart S, Stevens-Lapsley JE, Reusch JEB, Dunn AL, Regensteiner JG. Integrating a physical activity coaching intervention into diabetes care: a mixed-methods evaluation of a pilot pragmatic trial. Transl Behav Med. 2022 May 25;12(4):601-610. doi: 10.1093/tbm/ibac014.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): July 29, 2019

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: June 12, 2015
• First Posted (Estimated): June 17, 2015

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Physical Function; Sedentary Lifestyle; Physical Impairment
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 15-1080; K23HL118133 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO