Effect of a Home-Based Exercise Intervention of Wearable Technology and Telephone Coaching on Walking Performance in Peripheral Artery Disease
Authors: Mary M. McDermott, Bonnie Spring, Jeffrey S. Berger, Diane Treat-Jacobson, Michael S. Conte, Mark A. Creager, Michael H. Criqui, Luigi Ferrucci, Heather L. Gornik, Jack M. Guralnik, Elizabeth A. Hahn, Peter Henke, Melina R. Kibbe, Debra Kohlman-Trigoboff, Lingyu Li, Donald Lloyd-Jones, Walter McCarthy, Tamar S. Polonsky, Christopher Skelly, Lu Tian, Lihui Zhao, Dongxue Zhang, W. Jack Rejeski
Journal: JAMA (2018)

<h3>Importance</h3> Clinical practice guidelines support home-based exercise for patients with peripheral artery disease (PAD), but no randomized trials have tested whether an exercise intervention without periodic medical center visits improves walking performance. <h3>Objective</h3> To determine whether a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching improves walking ability over 9 months in patients with PAD. <h3>Design, Setting, and Participants</h3> Randomized clinical trial conducted at 3 US medical centers. Patients with PAD were randomized between June 18, 2015, and April 4, 2017, to home-based exercise vs usual care for 9 months. Final follow-up was on December 5, 2017. <h3>Interventions</h3> The exercise intervention group (n = 99) received 4 weekly medical center visits during the first month followed by 8 months of a wearable activity monitor and telephone coaching. The usual care group (n = 101) received no onsite sessions, active exercise, or coaching intervention. <h3>Main Outcomes and Measures</h3> The primary outcome was change in 6-minute walk distance at 9-month follow-up (minimal clinically important difference [MCID], 20 m). Secondary outcomes included 9-month change in subcomponents of the Walking Impairment Questionnaire (WIQ) (0-100 score; 100, best), SF-36 physical functioning score, Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire (higher = better; MCID, 2 points), PROMIS satisfaction with social roles questionnaire, PROMIS pain interference questionnaire (lower = better; MCID range, 3.5-4.5 points), and objectively measured physical activity. <h3>Results</h3> Among 200 randomized participants (mean [SD] age, 70.2 [10.4] years; 105 [52.5%] women), 182 (91%) completed 9-month follow-up. The mean change from baseline to 9-month follow-up in the 6-minute walk distance was 5.5 m in the intervention group vs 14.4 m in the usual care group (difference, −8.9 m; 95% CI, −26.0 to 8.2 m;<i>P</i> = .31). The exercise intervention worsened the PROMIS pain interference score, mean change from baseline to 9 months was 0.7 in the intervention group vs −2.8 in the usual care group (difference, 3.5; 95% CI, 1.3 to 5.8;<i>P</i> = .002). There were no significant between-group differences in the WIQ score, the SF-36 physical functioning score, or the PROMIS mobility or satisfaction with social roles scores. <h3>Conclusions and Relevance</h3> Among patients with PAD, a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching, compared with usual care, did not improve walking performance at 9-month follow-up. These results do not support home-based exercise interventions of wearable devices and telephone counseling without periodic onsite visits to improve walking performance in patients with PAD. <h3>Trial Registration</h3> clinicaltrials.gov Identifier:NCT02462824