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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
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 (+).
catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)
International Heart Institute of Montana Foundation
Missoula, Montana, United States
Change in peak walking time (PWT)
Time frame: Baseline, post-revascularization (ET or open intervention) (4 weeks, if applicable), post-12 weeks (exercise and control groups), 6 months following intervention time period
Change in claudication onset time (COT)
Time frame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Change in patient-reported outcomes
Time frame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Change in peak oxygen uptake
Time frame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Change in functional ability
Functional ability will be assessed with the 6-min walk test and Short Physical Performance Battery which consists of 1) walking short distances, 2) completing balance tests and 3) sit and standing from a chair 5 times.
Time frame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Evaluation of total volume of activity
Time frame: post-12 weeks (exercise and control groups)
Evaluation of exercise adherence
For patients randomized to the exercise therapy group
Time frame: post-12 weeks (exercise and control groups)
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revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)