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Cardiology

Effect of a Home-Based Exercise Intervention of Wearable Technology and Telephone Coaching on Walking Performance in Peripheral Artery DiseaseThe HONOR Randomized Clinical Trial

Educational Objective
To learn about exercise interventions for patients with peripheral artery disease.

1 Credit CME

JAMA

April 24, 2018

Original Investigation

Article Information and Disclosures

Author Affiliations

¹Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois
²Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois
³Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois
⁴Weinberg College of Arts and Sciences, Northwestern University, Evanston, Illinois
⁵Department of Preventative Cardiology, New York University School of Medicine, New York, New York
⁶Center for Aging Science and Care Innovation, University of Minnesota School of Nursing, Minneapolis
⁷Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco
⁸Department of Vascular Medicine, Dartmouth-Hitchcock Medical Center, Dartmouth Geisel School of Medicine, Hanover, New Hampshire
⁹Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California, San Diego
¹⁰Division of Intramural Research, National Institute on Aging, Baltimore, Maryland
¹¹Department of Cardiovascular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, Ohio
¹²Department of Epidemiology, University of Maryland, Baltimore
¹³Department of Surgery, University of Michigan, Ann Arbor
¹⁴Department of Surgery, University of North Carolina School of Medicine, Chapel Hill
¹⁶Department of Cardiovascular and Thoracic Surgery, Rush University Medical Center, Chicago, Illinois
¹⁷Department of Medicine, University of Chicago Medical School, Chicago, Illinois
¹⁸Department of Surgery, University of Chicago Medical School, Chicago, Illinois
¹⁹Department of Health Research and Policy, Stanford University, Stanford, California
²⁰Department of Health and Exercise Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina

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Key Points

Question Among patients with lower-extremity peripheral artery disease (PAD), does a home-based exercise intervention that consists of a wearable activity monitor and telephone coaching improve walking performance?

Findings In this randomized clinical trial of 200 participants with PAD, a wearable activity monitor combined with telephone coaching did not significantly improve 6-minute walk distance at 9 months (5.5 m in the intervention group vs 14.4 m in the usual care group).

Meaning These results do not support home-based exercise interventions of wearable devices combined with telephone coaching to improve walking performance in patients with PAD.

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 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

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Article Information

Corresponding Author: Mary M. McDermott, MD, Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Dr, Chicago, IL 60611 (mdm608@northwestern.edu).

Accepted for Publication: March 6, 2018.

Correction: This article was corrected on July 3, 2018, to fix an author’s name that was misspelled in the byline, add the correct academic degrees, and fix the spelling of the last name in the Author Contributions section.

Author Contributions: Dr Tian had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: McDermott, Spring, Treat-Jacobson, Conte, Creager, Criqui, Ferrucci, Gornik, Guralnik, Hahn, Henke, Kibbe, Tian, Zhao, Rejeski.

Acquisition, analysis, or interpretation of data: McDermott, Spring, Berger, Treat-Jacobson, Creager, Criqui, Ferrucci, Gornik, Guralnik, Hahn, Kibbe, Kohlman-Trigoboff, Li, Lloyd-Jones, McCarthy, Polonsky, Skelly, Tian, Zhao, Zhang, Rejeski.

Drafting of the manuscript: McDermott, Hahn, Li, Tian, Zhang.

Critical revision of the manuscript for important intellectual content: McDermott, Spring, Berger, Treat-Jacobson, Conte, Creager, Criqui, Ferrucci, Gornik, Guralnik, Hahn, Henke, Kibbe, Kohlman-Trigoboff, Li, Lloyd-Jones, McCarthy, Polonsky, Skelly, Zhao, Zhang, Rejeski.

Statistical analysis: Guralnik, Li, Tian, Zhao, Zhang.

Obtained funding: McDermott, Rejeski.

Administrative, technical, or material support: McDermott, Berger, Criqui, Kibbe, McCarthy, Polonsky, Skelly.

Supervision: McDermott, Spring, McCarthy, Rejeski.

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.

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.

Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: Dr McDermott is Senior Editor of JAMA, but she was not involved in any of the decisions regarding review of the manuscript or its acceptance.

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Effect of a Home-Based Exercise Intervention of Wearable Technology and Telephone Coaching on Walking Performance in Peripheral Artery DiseaseThe HONOR Randomized Clinical Trial

Incorrect Name and Degrees Listed for an Author

Use of a Wearable Activity Monitor in a Home-Based Exercise Intervention for Peripheral Artery Disease

Use of a Wearable Activity Monitor in a Home-Based Exercise Intervention for Peripheral Artery Disease—Reply

Effect of a Home-Based Exercise Intervention of Wearable Technology and Telephone Coaching on Walking Performance in Peripheral Artery DiseaseThe HONOR Randomized Clinical Trial

Incorrect Name and Degrees Listed for an Author

Use of a Wearable Activity Monitor in a Home-Based Exercise Intervention for Peripheral Artery Disease

Use of a Wearable Activity Monitor in a Home-Based Exercise Intervention for Peripheral Artery Disease—Reply

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