# Telehealth delivered home-based walking for vets with Peripheral Artery Disease (TREK-PAD)

> **NIH VA I01** · BIRMINGHAM VA MEDICAL CENTER · 2024 · —

## Abstract

ABSTRACT
Over 8 million Americans carry a diagnosis of peripheral artery disease (PAD), which is associated with a
significant risk for functional disability, cardiovascular events, and death. Furthermore, the risk of PAD and
adverse outcomes related to PAD, including amputations, are greater among minority groups. It is well known
that physical activity, such as walking, can reduce the risk of cardiovascular disease (CVD) and all-cause
mortality among vascular patients. For patients with PAD who experience claudication (pain with walking), PAD
management should include regular exercise such as walking. Despite guideline recommendations for center-
based exercise programs, few facilities offer such programs. Among those that offer center-based programs,
patients experience significant barriers to attendance. Developing effective and accessible interventions to
promote physical activity among patients, including Veterans who have high PAD rates, is warranted.
 The purpose of this proposed study is to evaluate two delivery methods of home-based walking among
Veterans with PAD, using an innovative sequential multiple assignments, randomized trial (SMART) design to
compare a web-based delivered walking program, and a video telehealth delivered walking program versus
usual care among 225 Veterans with PAD in three sites (Birmingham AL, Palo Alto CA, and Denver CO).
Participants will be randomized to 1 of 3 arms; (i) the web-based delivered (WBD) program, (ii) the video
telehealth delivered (VTD) program, or (iii) usual care (UC). All participants, irrespective of study assignment,
will receive 2 in-person visits with an exercise physiologist prior to randomization. After 12-weeks, participants
in the WBD arm who do not respond will be further randomized to receive WBD + VTD or WBD only. At 24-
weeks, participants in the VTD arm who do not respond will be further randomized to receive VTD + WBD or
VTD only. Nonresponse will be defined as a <15% increase in maximal walk distance compared to baseline
(measured with a validated treadmill protocol at 12-weeks). The interventions will then continue for an additional
12-weeks. After the 24-week visit, participants will be followed for an additional 12 weeks to examine longer-
term responses for a total participant study duration of 36-weeks. Visits at baseline, 12-, 24- and 36-weeks
include maximal and pain-free walking distance and health-related quality of life (HRQOL). The primary outcome
of interest will be change in maximal walking distance from baseline to 12-weeks. Secondary outcomes include
change in maximal walking distance at 24-, and 36-weeks, and change in pain-free walking distance, and
HRQOL at 12-, 24- and 36-weeks. Primary and secondary outcomes will be measured in all participants.
Impact: This trial will be the first to use a SMART design to compare two delivery methods for a home-based
walking program tailored to Veterans with PAD. With this study, we address a major gap in current knowled...

## Key facts

- **NIH application ID:** 10750260
- **Project number:** 1I01RX003965-01A2
- **Recipient organization:** BIRMINGHAM VA MEDICAL CENTER
- **Principal Investigator:** Elizabeth A. Jackson
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2024-01-01 → 2027-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10750260

## Citation

> US National Institutes of Health, RePORTER application 10750260, Telehealth delivered home-based walking for vets with Peripheral Artery Disease (TREK-PAD) (1I01RX003965-01A2). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10750260. Licensed CC0.

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