NCT02075502

Community Walking Exercise for Patients With Peripheral Artery Disease

A Community-based Exercise Program to Improve Walking Outcomes in Patients With Peripheral Artery Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of the study is to determine the effect of a community-based walking exercise program with detailed training, monitoring, and coaching (TMC) exercise components enhanced by community-based participatory research (CBPR) practices (TMC+) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).

Detailed description

The investigators will test the hypothesis that PAD patients randomized to the exercise program in the community setting incorporating TMC+ will improve walking ability compared with patients who receive the standard of care (exercise advice). Secondary hypotheses include a significant improvement in patient-reported outcomes, an improvement in functional ability or a significant increase in volume of physical activity for patients who complete community-based walking exercise when compared with patients receiving the standard of care. Exploratory hypotheses include a significant improvement in PWT for 1) patients receiving a combination of lower extremity endovascular therapy (ET) and community-based walking exercise or 2) open peripheral intervention and community-based walking exercise compared to patients who do not receive endovascular therapy or open intervention and receive only the standard of care.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
BEHAVIORAL	Exercise therapy	The exercise therapy program with training, monitoring and coaching enhanced by community-based participatory research (CBPR) (TMC+) is a comprehensive approach to community-based walking exercise for improving PAD patient outcomes. The components of TMC+ are optimal training guidelines for patients (i.e., T), monitoring from both investigators and patient self-monitoring (i.e., M), coaching from investigators on how to improve patients' walking ability (i.e., C), and finally enhancements from CBPR practices (+).
PROCEDURE	lower extremity ET	catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)
PROCEDURE	peripheral open intervention	revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)

Timeline

• Start date: 2014-02-01
• Primary completion: 2020-02-12
• Completion: 2020-02-12
• First posted: 2014-03-03
• Last updated: 2020-04-22

Locations

1 site across 1 country: United States