• 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 Tian, Lihui Zhao, Dongxue Zhang, and W Jack Rejeski.
• Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
• JAMA. 2018 Apr 24; 319 (16): 1665-1676.

ImportanceClinical 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.ObjectiveTo 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.Design, Setting, And ParticipantsRandomized 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.InterventionsThe 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 MeasuresThe 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.ResultsAmong 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; 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 RelevanceAmong 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.Trial Registrationclinicaltrials.gov Identifier: NCT02462824.

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