Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

University of Colorado Denver (CU Denver)

Status: Completed

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

Treatments: Behavioral: Questionnaires; Behavioral: Physical Activity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02473926

K23HL118133 (U.S. NIH Grant/Contract)

15-1080

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

55 participants in 2 patient groups

Physical Activity Program Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity

Usual Care Group

Other group

Description:

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.

Treatment:

Behavioral: Questionnaires