The telehealth vs. web-based delivered home-based walking for Veterans with peripheral artery disease (TREK-PAD) trial

Abstract: Background: Facility-based exercise such as walking is recommended for adults with peripheral artery disease (PAD). PAD is prevalent among US Veterans; thus, understanding effective methods for delivering home-based PAD exercise programs to Veterans is clinically important. Methods: Veterans with documented PAD will be recruited from three sites (Birmingham, AL, Aurora, CO, and Palo Alto, CA) for a sequential multiple assignment randomized trial (SMART) comparing a web-based delivered walking program to a telehealth delivered walking program or usual care. After 12-weeks of the walking program, participants assigned to one of the walking program intervention arms who do not increase their maximal walking distance will be re-randomized to either receive both web-based and telehealth programs or continue their original assignment till week 24. Follow-up will continue for a third 12-weeks for a total duration of 36-weeks. A total of 225 Veterans will be recruited. The primary outcome of maximal walking distance will be assessed at baseline, 12, 24, and 36-weeks with a standardized treadmill protocol. Additional outcomes include pain-free walking distance and changes in health-related quality of life, measured at the same time points. Conclusion: Determining the efficacy of delivering a home-based walking program can address barriers to facility-based programs which are often not available and create participant burden, particularly to those residing in rural areas distant from healthcare facilities. Veterans are both vulnerable to such barriers and overburdened by PAD. This study will contribute to current evidence related to home-based exercise interventions for Veterans with PAD.

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