Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02473926

Collaborator

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

Enrollment

Location

Arms

43.9

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Motor Activity Health Behavior Diabetes Mellitus, Type 2	Behavioral: Physical Activity Behavioral: Questionnaires	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jul 29, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline in Objective Physical Activity at 4 months [Week 1; Week 14]
ActiGraph accelerometer measures physical activity objectively as minutes/week of moderate intensity and vigorous intensity physical activity, respectively.

Secondary Outcome Measures

Change from Baseline in Physical Function at 4 months [Week 1; week 14]
Measured via 400-meter rapid gait speed test
Change from Baseline in Physical Function at 4 months [Week 0, Week 14]
Measured via the Short Physical Performance Battery (SPPB), which evaluates balance, usual walking speed, and repeated chair rise.
Change from Baseline in Grip Strength at 4 months [Week 2; Week 15]
Hand grip strength as measured by dynamometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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