Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473926
• Other study ID #: 15-1080
• Secondary ID: K23HL118133
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: July 29, 2019

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 29, 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Health Behavior
• Motor Activity

Intervention

Behavioral:
• Physical Activity
Physical Activity Program Intervention
• Questionnaires
Participants in the usual care arm will receive three mailings during the intervention phase.

Locations

Country	Name	City	State
United States	University of Colorado Denver | Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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