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Community Walking Exercise for Patients With Peripheral Artery Disease

NCT02075502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-04-22

No results posted yet for this study

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).

Conditions

Interventions

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)

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

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

    collaborator NIH

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Ryan J. Mays, PhD, MPH, MS · International Heart Institute of Montana Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-01
Primary Completion
2020-02-12
Completion
2020-02-12

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02075502 on ClinicalTrials.gov