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 language||English (US)|
|Number of pages||12|
|Journal||JAMA - Journal of the American Medical Association|
|State||Published - Apr 24 2018|
Bibliographical noteFunding Information:
Funding/Support: The study was supported by grant CER-1306-02719 from the Patient-Centered Outcomes Research Institute and funding from the intramural program at the National Institute on Aging.
completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr McDermott reported receiving grant funding from the National Heart, Lung, and Blood Institute, the National Institute on Aging, Novartis, and Regeneron; nonfinancial support from ViroMed; and the study drug for another peripheral artery disease study from ReserveAge and Hershey’s. Dr Spring reported serving on an ActiGraph scientific advisory board. Dr Berger reported receiving grant funding from AstraZeneca, Janssen, and the National Institutes of Health. Dr Conte reported serving on the clinical advisory board for Abbott Vascular; serving on the scientific advisory board for Symic; and receiving funding from the National Heart, Lung, and Blood Institute. Dr Gornik reported receiving research support from AstraZeneca; and having a patent pending regarding a method to measure ankle brachial index. Dr Guralnik reported receiving personal fees from Pluristem Pharma, Boeringer-Ingleheim, and Viking Therapeutics. Dr Skelly reported having editor royalty agreements with Springer and Inside Ultrasound; and being the co-founder of Maji Therapeutics. No other disclosures were reported.
The study was supported by grant CER-1306-02719 from the Patient-Centered Outcomes Research Institute and funding from the intramural program at the National Institute on Aging.
© 2018 American Medical Association. All rights reserved.