Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease: The honor randomized clinical trial

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-Trighoff, Lingyu Li, Donald Lloyd-Jones, Walter McCarthy, Tamar S. Polonsky, Christopher Skelly, Lu TianLihui Zhao, Dongxue Zhang, W. Jack Rejeski

*Corresponding author for this work

Research output: Contribution to journalArticle

31 Scopus citations

Abstract

IMPORTANCE: 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. OBJECTIVE: To determine whether a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching improves walking ability over 9 months inpatients with PAD. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: 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. MAIN OUTCOMES AND MEASURES: 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. RESULTS: Among200 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; P =.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; P =.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. CONCLUSIONS AND RELEVANCE: 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.

Original languageEnglish (US)
Pages (from-to)1665-1676
Number of pages12
JournalJAMA - Journal of the American Medical Association
Volume319
Issue number16
DOIs
StatePublished - Apr 24 2018

ASJC Scopus subject areas

  • Medicine(all)

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    McDermott, M. M., Spring, B., Berger, J. S., Treat-Jacobson, D., Conte, M. S., Creager, M. A., Criqui, M. H., Ferrucci, L., Gornik, H. L., Guralnik, J. M., Hahn, E. A., Henke, P., Kibbe, M. R., Kohlman-Trighoff, D., Li, L., Lloyd-Jones, D., McCarthy, W., Polonsky, T. S., Skelly, C., ... Rejeski, W. J. (2018). Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease: The honor randomized clinical trial. JAMA - Journal of the American Medical Association, 319(16), 1665-1676. https://doi.org/10.1001/jama.2018.3275