Rationale and design of a smartphone‐enabled, home‐based exercise program in patients with symptomatic peripheral arterial disease: The smart step randomized trial

• Authors: Arash Harzand, Emory University; Alexander Vakili, Emory University; Alaaeddin Alrohaibani, Atlanta Veterans Affairs Medical Center; Smah M. Abdelhamid, Atlanta Veterans Affairs Medical Center; Neil F. Gordon, University of the Witwatersrand; John Thiel, INTERVENT International; Jaime Benarroch-Gampel, Emory University; Victoria Teodorescu, Emory University; Keri Minton, Grady Memorial Hospital; Nanette Wenger, Emory University; Ravi Rajani, Emory University; Amit Shah, Emory University
• Journal Title: CLINICAL CARDIOLOGY
• Volume: Volume 43, Number 6
• Publisher: Wiley Open Access | 2020-04-23, Pages 537-545
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1002/clc.23362
• Subjects: Health Sciences, Rehabilitation and Therapy; Health Sciences, Health Care Management; Health Sciences, Public Health
• Keywords: Supervised exercise therapy; symptomatic peripheral arterial disease; first‐line therapy; patient adoption; Home‐based exercise therapy; virtual solutions; feasibility

Abstract

Background Supervised exercise therapy (SET) is recommended in patients with symptomatic peripheral arterial disease (PAD) as first‐line therapy, although patient adoption remains low. Home‐based exercise therapy (HBET) delivered through smartphones may expand access. The feasibility of such programs, especially in low‐resource settings, remains unknown. Methods Smart Step is a pilot randomized trial of smartphone‐enabled HBET vs walking advice in patients with symptomatic PAD in an inner‐city hospital. Participants receive a smartphone app with daily exercise reminders and educational content. A trained coach performs weekly phone‐based coaching sessions. All participants receive a Fitbit Charge HR 2 to measure physical activity. The primary outcome changes in 6‐minute walking test (6MWT) distance at 12 weeks over baseline. Secondary outcomes are the degree of engagement with the smartphone app and changes in health behaviors and quality of life scores after 12 weeks and 1 year. Results A total of 15 patients are randomized as of December 15, 2019 with a mean (SD) age of 66.1 (5.8) years. The majority are female (60%) and black (87%). At baseline, the mean (SD) ABI and 6MWT were 0.86 (0.29) and 363.5 m, respectively. Enrollment is expected to continue until December 2020 to achieve a target size of 50 participants. Conclusions The potential significance of this trial will be to provide preliminary evidence of a home‐based, “mobile‐first” approach for delivering a structured exercise rehabilitation program. Smartphone‐enabled HBET can be potentially more accessible than center‐based programs, and if proven effective, may have a potential widespread public health benefit.