PMID- 29710165 OWN - NLM STAT- MEDLINE DCOM- 20180507 LR - 20181114 IS - 1538-3598 (Electronic) IS - 0098-7484 (Print) IS - 0098-7484 (Linking) VI - 319 IP - 16 DP - 2018 Apr 24 TI - 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. PG - 1665-1676 LID - 10.1001/jama.2018.3275 [doi] AB - 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 in patients 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: 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; 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02462824. FAU - McDermott, Mary M AU - McDermott MM AD - Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. AD - Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. FAU - Spring, Bonnie AU - Spring B AD - Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. AD - Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois. AD - Weinberg College of Arts and Sciences, Northwestern University, Evanston, Illinois. FAU - Berger, Jeffrey S AU - Berger JS AD - Department of Preventative Cardiology, New York University School of Medicine, New York, New York. FAU - Treat-Jacobson, Diane AU - Treat-Jacobson D AD - Center for Aging Science and Care Innovation, University of Minnesota School of Nursing, Minneapolis. FAU - Conte, Michael S AU - Conte MS AD - Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco. FAU - Creager, Mark A AU - Creager MA AD - Department of Vascular Medicine, Dartmouth-Hitchcock Medical Center, Dartmouth Geisel School of Medicine, Hanover, New Hampshire. FAU - Criqui, Michael H AU - Criqui MH AD - Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California, San Diego. FAU - Ferrucci, Luigi AU - Ferrucci L AD - Division of Intramural Research, National Institute on Aging, Baltimore, Maryland. FAU - Gornik, Heather L AU - Gornik HL AD - Department of Cardiovascular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, Ohio. FAU - Guralnik, Jack M AU - Guralnik JM AD - Department of Epidemiology, University of Maryland, Baltimore. FAU - Hahn, Elizabeth A AU - Hahn EA AD - Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. FAU - Henke, Peter AU - Henke P AD - Department of Surgery, University of Michigan, Ann Arbor. FAU - Kibbe, Melina R AU - Kibbe MR AD - Department of Surgery, University of North Carolina School of Medicine, Chapel Hill. FAU - Kohlman-Trighoff, Debra AU - Kohlman-Trighoff D AD - Department of Cardiology and Cardiovascular Medicine, Duke University, Durham, North Carolina. FAU - Li, Lingyu AU - Li L AD - Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. FAU - Lloyd-Jones, Donald AU - Lloyd-Jones D AD - Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. AD - Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. FAU - McCarthy, Walter AU - McCarthy W AD - Department of Cardiovascular and Thoracic Surgery, Rush University Medical Center, Chicago, Illinois. FAU - Polonsky, Tamar S AU - Polonsky TS AD - Department of Medicine, University of Chicago Medical School, Chicago, Illinois. FAU - Skelly, Christopher AU - Skelly C AD - Department of Surgery, University of Chicago Medical School, Chicago, Illinois. FAU - Tian, Lu AU - Tian L AD - Department of Health Research and Policy, Stanford University, Stanford, California. FAU - Zhao, Lihui AU - Zhao L AD - Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. FAU - Zhang, Dongxue AU - Zhang D AD - Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. FAU - Rejeski, W Jack AU - Rejeski WJ AD - Department of Health and Exercise Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina. LA - eng SI - ClinicalTrials.gov/NCT02462824 PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Intramural PL - United States TA - JAMA JT - JAMA JID - 7501160 SB - IM EIN - JAMA. 2018 Jul 3;320(1):96. PMID: 29971378 CIN - JAMA. 2018 Sep 25;320(12):1285-1286. PMID: 30264109 MH - Aged MH - Exercise Therapy/*methods MH - Female MH - *Home Nursing MH - Humans MH - Male MH - Middle Aged MH - Patient Compliance MH - Peripheral Arterial Disease/physiopathology/*rehabilitation MH - Surveys and Questionnaires MH - Telemedicine MH - Telephone MH - *Walking MH - *Wearable Electronic Devices PMC - PMC5933394 COIS- Conflict of Interest Disclosures: The authors have 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. EDAT- 2018/05/02 06:00 MHDA- 2018/05/08 06:00 PMCR- 2018/10/24 CRDT- 2018/05/01 06:00 PHST- 2018/05/01 06:00 [entrez] PHST- 2018/05/02 06:00 [pubmed] PHST- 2018/05/08 06:00 [medline] PHST- 2018/10/24 00:00 [pmc-release] AID - 2679277 [pii] AID - joi180033 [pii] AID - 10.1001/jama.2018.3275 [doi] PST - ppublish SO - JAMA. 2018 Apr 24;319(16):1665-1676. doi: 10.1001/jama.2018.3275.