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JAMA. 2018 Apr 24;319(16):1665-1676. doi: 10.1001/jama.2018.3275.

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.

Author information

1
Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
2
Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
3
Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
4
Weinberg College of Arts and Sciences, Northwestern University, Evanston, Illinois.
5
Department of Preventative Cardiology, New York University School of Medicine, New York, New York.
6
Center for Aging Science and Care Innovation, University of Minnesota School of Nursing, Minneapolis.
7
Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco.
8
Department of Vascular Medicine, Dartmouth-Hitchcock Medical Center, Dartmouth Geisel School of Medicine, Hanover, New Hampshire.
9
Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California, San Diego.
10
Division of Intramural Research, National Institute on Aging, Baltimore, Maryland.
11
Department of Cardiovascular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, Ohio.
12
Department of Epidemiology, University of Maryland, Baltimore.
13
Department of Surgery, University of Michigan, Ann Arbor.
14
Department of Surgery, University of North Carolina School of Medicine, Chapel Hill.
15
Department of Cardiology and Cardiovascular Medicine, Duke University, Durham, North Carolina.
16
Department of Cardiovascular and Thoracic Surgery, Rush University Medical Center, Chicago, Illinois.
17
Department of Medicine, University of Chicago Medical School, Chicago, Illinois.
18
Department of Surgery, University of Chicago Medical School, Chicago, Illinois.
19
Department of Health Research and Policy, Stanford University, Stanford, California.
20
Department of Health and Exercise Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina.

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.

PMID:
29710165
PMCID:
PMC5933394
DOI:
10.1001/jama.2018.3275
[Indexed for MEDLINE]
Free PMC Article

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