Research

JAMA | Original Investigation

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
Mary M. McDermott, MD; Bonnie Spring, MD; Jeffrey S. Berger, MD; Diane Treat-Jacobson, PhD, RN; Michael S. Conte, MD; Mark A. Creager, MD;
Michael H. Criqui, MD, MPH; Luigi Ferrucci, MD, PhD; Heather L. Gornik, MD; Jack M. Guralnik, MD, PhD; Elizabeth A. Hahn, MA; Peter Henke, MD;
Melina R. Kibbe, MD; Debra Kohlman-Trighoff, PhD, RN; Lingyu Li, MS; Donald Lloyd-Jones, MD, ScM; Walter McCarthy, MD; Tamar S. Polonsky, MD;
Christopher Skelly, MD; Lu Tian, ScD; Lihui Zhao, PhD; Dongxue Zhang, MS; W. Jack Rejeski, PhD

Supplemental content
IMPORTANCE Clinical practice guidelines support home-based exercise for patients with CME Quiz at
peripheral artery disease (PAD), but no randomized trials have tested whether an exercise jamanetwork.com/learning
intervention without periodic medical center visits improves walking performance. and CME Questions page 1719

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 Author Affiliations: Author
affiliations are listed at the end of this
consisting of a wearable activity monitor and telephone coaching, compared with usual care,
article.
did not improve walking performance at 9-month follow-up. These results do not support
Corresponding Author: Mary M.
home-based exercise interventions of wearable devices and telephone counseling without McDermott, MD, Division of General
periodic onsite visits to improve walking performance in patients with PAD. Internal Medicine and Geriatrics,
Northwestern University
TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02462824 Feinberg School of Medicine, 750 N
Lake Shore Dr, Chicago, IL 60611
JAMA. 2018;319(16):1665-1676. doi:10.1001/jama.2018.3275 (mdm608@northwestern.edu).

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 Research Original Investigation Effect of a Home-Based Exercise Intervention on Walking Performance in Peripheral Artery Disease
S
upervised treadmill exercise significantly improves walk-
ing performance in patients with lower-extremity pe-
ripheral artery disease (PAD) and is recommended by
clinical practice guidelines as a first-line therapy (class IA rec-
ommendation: supervised treadmill exercise is recom-
mended or should be performed based on high-quality evi-
dence from >1 randomized clinical trial).1-5 However, traveling
to an exercise center 3 times per week for supervised tread-
mill exercise can be burdensome and many patients with PAD
decline participation.2,6
Practice guidelines also recommend home-based walking
exercise for patients with PAD (class IIA recommendation: treat-
ment is reasonable and can be useful based on high-quality evi-
dence from >1 randomized clinical trial).1 This recommenda-
tion is based on 3 randomized trials in which the home-based
exercise interventions required periodic visits to the medical
center every 1 to 4 weeks throughout the intervention.1,2,7-9
Functional impairment is common in patients with PAD,
including in those without classic claudication symptoms.10,11
Effective interventions that do not require regular medical cen-
ter visits are likely to be more accessible and acceptable to pa-
tients with PAD than exercise interventions requiring peri-
odic medical center visits.
In the Home-Based Monitored Exercise for PAD (HONOR)
randomized clinical trial, feedback from patients with PAD was
used to design an appealing home-based exercise interven-
tion. The trial tested whether an intervention that combined
telephone coaching and a wearable activity monitor to pro-
mote home-based walking exercise (but did not require peri-
odic medical center visits throughout the intervention) sig-
nificantly improved walking endurance and patient-reported
outcomes at 9-month follow-up compared with usual care.
Methods
The institutional review board at Northwestern University and
all recruitment sites approved the protocol. Participants pro-
vided written, informed consent. Participants were random-
ized between June 18, 2015, and April 4, 2017. Randomiza-
tion ended when the target sample size was achieved. The final
follow-up visit was on December 5, 2017. The trial protocol ap-
pears in Supplement 1.
Patient Contributions to the Study Design
Focus groups and pilot studies of patients with PAD were held
to solicit feedback for designing an appealing trial. For ex-
ample, because of participant enthusiasm for a wearable activ-
ity monitor, a wearable activity monitor was incorporated into
the exercise intervention. Patients with PAD also were asked to
discuss meaningful outcomes and rank questionnaires accord-
ing to the degree to which each questionnaire measured how
PAD limits their daily life. The ranking of the patient question-
naires was used to select questionnaire outcomes.
Identification of Potential Participants
Three medical centers (University of Minnesota, New York Uni-
versity, and Northwestern University) participated. Potential
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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.
participants were identified from physician referrals, lists of
patients with PAD, and response to advertisements and mail-
ings to patients aged 50 years or older. In addition, patients with
PAD who previously participated in research at each center and
expressed interest in future research were contacted.
Inclusion Criteria
Inclusion criteria included patients with an ankle brachial
index (ABI) of 0.90 or less at baseline.12 Patients with an ABI
greater than 0.90 at baseline were eligible if a hospital-
affiliated vascular laboratory report demonstrated PAD, angi-
ography of lower extremities showed stenosis of 70% or
greater, or medical records documented prior revasculariza-
tion of lower extremities. In addition, patients with an ABI
from 0.90 to 1.00 were eligible if the ABI decreased by 20%
after a heel-rise test.13
Exclusion Criteria
A patient was excluded if he or she had an amputation below
or above the knee; was confined to a wheelchair; required use
of a walking aid other than a cane; had a walking impairment
for a reason other than PAD; or had a foot ulcer, critical limb
ischemia, or significant visual or hearing impairment. A pa-
tient was excluded if he or she had a major surgery or revas-
cularization during the previous 3 months or a planned sur-
gery or revascularization during the next 9 months; was
currently or recently (within the past 3 months) participating
in a clinical trial or cardiac rehabilitation; or had Parkinson dis-
ease or required oxygen with activity. A patient was excluded
if he or she had New York Heart Association class III or IV heart
failure or angina, an increase in angina pectoris during the prior
6 months, or an abnormal baseline stress test. A patient was
excluded if he or she was already exercising at a level similar
to the intervention, did not speak English, or if his or her walk-
ing was primarily limited by symptoms from something other
than PAD.
A patient who had been treated for cancer during the past
2 years was excluded unless it was early-stage cancer, the prog-
nosis was excellent, and the cancer was unlikely to return dur-
ing study enrollment. For these patients, eligibility was deter-
mined either by medical record review or by direct consultation
between the principal investigator (M.M.M.) and the treating
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 Effect of a Home-Based Exercise Intervention on Walking Performance in Peripheral Artery Disease
physician. Patients with a Mini-Mental State Examination score
of less than 23 were excluded.14
Patient Characteristics and Randomization
A handheld Doppler instrument (Pocket-Dop II, Nicolet Vascular)
was used to measure systolic pressures in the right brachial, dor-
salis pedis, and posterior tibial arteries and left dorsalis pedis,
posterior tibial, and brachial arteries. Each pressure was mea-
sured twice. The ABI was calculated by dividing mean pres-
sures in each leg by the mean of the 4 brachial pressures.15
Medical history and race/ethnicity were obtained using an
open-ended question by trained staff.3,4 Race/ethnicity data
were required by the funding agency and allowed assess-
ment of the generalizability of the results. Height and weight
were measured. Body mass index was calculated as weight in
kilograms divided by height in meters squared.
Leg symptoms were characterized with the San Diego
Claudication Questionnaire.16 Intermittent claudication was
defined as exertional calf pain that did not begin at rest,
caused the patient to stop walking, and resolved within 10
minutes of rest. Participants without intermittent claudica-
tion were either asymptomatic (ie, reported no exertional leg
symptoms) or had exertional leg symptoms other than inter-
mittent claudication.11,16
Participants were randomized to 1 of 2 groups using a com-
puter-generated randomization list. Randomization was strati-
fied by study site and used block randomization and ran-
domly selected block sizes of 4, 6, or 8.
Intervention
Home-Based Exercise
The home-based exercise intervention was designed based
on patient feedback and incorporated social cognitive theory
and self-regulation concepts that are important for behav-
ioral change.17,18 During the first month of the intervention,
participants were asked to attend 4 weekly sessions with the
coach (weeks 1 and 2) or with other participants and the
coach (weeks 3 and 4). During these sessions, participants
walked for exercise and were assisted in setting goals for
walking exercise and shown how to enter their walking exer-
cise activity on the study website.
After the first month, participant contact with the coach
was primarily by telephone and there were no scheduled onsite
medical center visits. The coach called participants once per
week during months 1 and 2, once every other week during
months 3, 4, and the first half of month 5, and once per month
during the latter half of month 5 through month 9. Telephone
calls were structured and included discussion of progress to-
ward exercise goals, review of the wearable activity monitor
data, challenges encountered, strategies to overcome chal-
lenges, setting of new walking exercise goals, and a summary
of the telephone call content.
The intervention was individualized. Participants were typi-
cally advised to exercise 5 days per week either indoors or out-
doors and beginning with 10 to 15 minutes of exercise per ses-
sion and working up to 50 minutes per session. Participants were
asked to walk until they experienced severe leg discomfort and
then rest until they were able to resume walking.
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Original Investigation Research
If participants could walk for 10 minutes without stop-
ping due to ischemic leg symptoms, they were asked to in-
crease their walking exercise speed (intensity). Participants
without exertional leg discomfort were asked to walk with
an intensity rating of 12/20 to 14/20 on the Borg Rating of
Perceived Exertion scale.19 These methods were used success-
fully to improve 6-minute walk distance during a previous ran-
domized trial of home exercise that included weekly medical
center visits.9
Participants received a wearable activity monitor (FitBit
Zip, FitBit Inc) to monitor their physical activity. This wear-
able device has been shown to be a valid and reliable measure
of walking activity with less than 1% error compared with other
validated activity monitors.20 Data from the wearable activ-
ity monitor were uploaded via Bluetooth on the study web-
site and were visible to both the participant and coach.
Participants without a home computer or tablet were pro-
vided with a tablet for the study duration. During telephone
contact with the coach, exercise goals (exercise frequency and
duration) were entered by the coach on the website. Partici-
pants were asked to enter the minutes they walked for exer-
cise on the website and this information was visible to the
coach. Twice per month, group telephone calls for interven-
tion participants were led by the coach and included a topic
of the month such as managing pain during exercise and ex-
ercising in cold weather. Participants were encouraged to share
their successes and challenges with other participants.
Usual Care
Participants randomized to usual care received no study in-
tervention. However, participants in both study groups were
telephoned monthly by a study coordinator other than the
coach to obtain data on adverse events. Information on physi-
cal activity and walking exercise frequency was collected dur-
ing these telephone calls every 3 months.
Outcomes
All prespecified outcomes were obtained by staff blinded to
group assignment at baseline and follow-up. Investigators were
blinded to outcome data until the end of the trial. The pri-
mary outcome was change in 6-minute walk distance be-
tween baseline and 9-month follow-up.
Secondary outcomes were changes between baseline and
9-month follow-up in Walking Impairment Questionnaire
(WIQ) distance, speed, and stair climbing scores; the Medical
Outcomes Study Short Form 36 (SF-36) physical functioning
score, the Patient-Reported Outcomes Measurement Informa-
tion System (PROMIS) measures of mobility, pain interfer-
ence, and satisfaction with social roles and activities,21-29 and
change in objectively measured physical activity.30 In pre-
specified exploratory analyses, these outcomes also were mea-
sured at 4½-month follow-up.
6-Minute Walk Distance Test
Change in 6-minute walk distance is a well-validated, objec-
tive measure of walking endurance among patients with
PAD.3,4,9,31 The 6-minute walk distance test was administered
by a trained and certified research assistant who followed
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 Research Original Investigation Effect of a Home-Based Exercise Intervention on Walking Performance in Peripheral Artery Disease
a standardized protocol. Participants walked up and down a
100-ft hallway for 6 minutes after being instructed to cover
as much distance as possible.3,4,9,31 The distance completed
after 6 minutes was recorded. Twenty meters was defined as
a minimal clinically important difference.32
Questionnaire Outcomes
The questionnaires were self-administered. The WIQ is a PAD-
specific measure of self-reported limitations with 3 domains:
walking distance, walking speed, and stair climbing.21 Each
domain is scored on a scale from 0 to 100 (100 indicating
the best possible score).21 A small minimal clinically impor-
tant difference has not been established for WIQ scores.
The SF-36 was used to assess functional status in the physical
functioning domain (scale from 0-100; 100 indicating the
best possible score).22 The minimal clinically important dif-
ference for the SF-36 physical functioning score ranges from
5 to 7 points.22,33
The PROMIS questionnaires measured perceived change
in mobility (mobility short form), ability to engage in social roles
and activities (satisfaction with social roles short form), and
the degree to which pain interfered with activities (pain inter-
ference short form).23-29 The PROMIS measures use a T-score
metric with a mean (SD) score of 50 (10) compared with the
general population.23 Higher scores are better for the ques-
tionnaires on mobility and satisfaction with social roles
and worse for the questionnaire on pain interference.24-29
The minimal clinically important difference is 2.0 points
for mobility 26 and ranges from 3.5 to 4.5 points for pain
interference.24 The minimal clinically important difference has
not been established for satisfaction with social roles.
Objectively Measured Physical Activity
Free-living physical activity (measured as total count per day)
was acquired over 7 days with an accelerometer (ActiGraph).
The accelerometer was worn on the right hip and removed only
for bathing or sleeping.30
Power Calculations
Statistical power was calculated for the primary outcome of
6-minute walk distance and for the secondary questionnaire
outcomes. We anticipated a 10% dropout rate at 9-month
follow-up.3,4,9,34 In previous trials of exercise among patients
with PAD,4,9 the SD range for change in 6-minute walk dis-
tance was 51 to 69 m. Therefore, 200 participants provided 80%
power for detecting a between-group difference for change in
6-minute walk distance of 21 to 29 m using a 2-sided 2-sample
t test with a significance level of .05.
Twenty meters is the minimal clinically important differ-
ence for the 6-minute walk distance.32 For the secondary
questionnaire outcomes and based on SDs from prior
studies,9,28,29 the trial had 80% power to detect a difference
of 10.1 in the WIQ distance score, 9.2 in the WIQ speed score,
and 3.3 in the PROMIS pain interference score.
Statistical Analysis
Analyses were performed according to the intention-to-treat
principle. Baseline characteristics were summarized as mean
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and SD for continuous measures and number and percentage
in each group. Changes in each outcome between baseline
and 9-month follow-up and between baseline and 4½-month
follow-up were compared between the groups using a
2-sample t test stratified by site. For the between-group dif-
ferences, 95% CIs were constructed. Analyses for changes in
outcomes between baseline and 4½-month follow-up and
between baseline and 9-month follow-up were performed
using multiple imputation for missing data and SAS Proc MI
(SAS Institute Inc) with 80 imputed data sets. Variables used
for imputation were age, ABI, body mass index, sex, race,
smoking status, outcome values, leg symptoms, and comor-
bidities. The final statistical inference accounted for imputa-
tion variabilities.
To estimate whether the intervention effects differed in
subgroups of participants, the primary outcome analyses
were repeated within subsets of participants grouped by
baseline characteristics using tests for interaction to deter-
mine statistical significance in post hoc exploratory analy-
ses. The analyses were stratified by site to adjust for poten-
tial differences among the 3 sites. The a priori level for
statistical significance was a 2-sided P < .05. For all of the
analyses, SAS version 9.4 was used. Because there were mul-
tiple secondary outcomes and no adjustment for multiple
comparisons, results for the secondary outcomes should be
interpreted as exploratory.
Results
Of 503 participants who provided written informed consent,
200 were randomized (Figure 1). The mean (SD) age was 70.2
(10.4) years, the mean (SD) ABI was 0.66 (0.15), 105 (52.5%)
were women, 100 (50%) were black, and 182 (91%) com-
pleted 9-month follow-up. The usual care group had a higher
prevalence of current or former cigarette smoking; however,
baseline characteristics were otherwise balanced between the
groups (Table 1).
Intervention Adherence and Rates of Walking for Exercise
Of the 99 participants randomized to the exercise interven-
tion group, 92 (93%) attended all 4 onsite visits. The
completion rate was 73.9% (1295 of 1753 participants) for
scheduled intervention telephone calls. After excluding par-
ticipants who died or dropped out, the completion rate was
79.2% (1204 of 1521 participants) for scheduled intervention
telephone calls. The follow-up rates were 89% (178 of 200
participants) at 4½ months and 91% (182 of 200 partici-
pants) at 9 months.
Thirteen participants (including 1 death) (6.5%) had no ac-
celerometer data at baseline or 4½-month follow-up. An ad-
ditional participant who died before 9-month follow-up had
no accelerometer data at baseline or at 9-month follow-up.
Of the remainder, data were imputed for at least 1 visit for
91 of 187 participants (49%) contributing to the 4½-month
change in accelerometer physical activity outcome and for 93
of 186 participants (50%) contributing to the 9-month change
in accelerometer physical activity outcome.
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 Effect of a Home-Based Exercise Intervention on Walking Performance in Peripheral Artery Disease Original Investigation Research

Figure 1. Study Participation and Follow-up Rates

503 Patients assessed for eligibility and

signed informed consent form

303 Excluded
242 Did not have PAD
34 Refused to participate
8 Abnormal, unwilling, or unable
to complete treadmill test
7 Exercise regularly
6 Gait problems other than
PAD that affect walking
2 Other health problems
that affect walking
2 Not able to contact
1 MMSE score <23
1 Already enrolled in another
trial

200 Randomized

99 Randomized to receive home-based 101 Randomized to receive usual care

exercise intervention 101 Received usual care as
95 Received intervention as randomized
randomized
4 Did not receive intervention as
randomized (did not participate
in any exercise sessions)

41⁄2-mo Follow-up 41⁄2-mo Follow-up

85 Completed follow-up 93 Completed follow-up
1 Died 3 Lost to follow-up MMSE indicates Mini-Mental State
8 Lost to follow-up 5 Canceled visit Examination; PAD, peripheral artery
5 Canceled visit disease. The reasons for exclusion
were not obtained for patients who
9-mo Follow-up 9-mo Follow-up
did not provide informed consent
because hundreds of potential
88 Completed follow-up 94 Completed follow-up
2 Died 4 Lost to follow-up participants without PAD were
9 Lost to follow-up 3 Canceled visit excluded by telephone prior to
attending a study visit and there were
insufficient resources to track the
97 Included in primary analysis 101 Included in primary analysis reasons for exclusion. The MMSE
2 Excluded (died)
score range is 0 to 30 (patients with a
score of <23 were excluded).

At 3-month follow-up, participants in the exercise inter-
vention group reported greater increases in walking exercise
frequency (from 1.7 episodes/week at baseline to 3.7 epi-
sodes/week; within-group difference, 2.0 episodes/week) vs
participants in the usual care group (from 1.5 episodes/week
at baseline to 2.2 episodes/week; within-group difference,
0.7 episodes/week) (between-group difference for the mean
change from baseline to follow-up, 1.3 episodes/week [95%
CI, 0.4 to 2.3 episodes/week], P = .005) and at 6-month
follow-up (from 1.7 to 4.3 episodes/week [within-group dif-
ference, 2.8 episodes/week] vs from 1.5 to 2.4 episodes/
week [within-group difference, 0.9 episodes/week], respec-
tively; between-group difference for the mean change from
baseline to follow-up, 1.9 episodes/week [95% CI, 0 to 3.8
episodes/week], P = .045).
At 9-month follow-up, there was no statistically signifi-
cant difference in reported walking exercise frequency for
the exercise intervention group (from 1.7 episodes/week at
baseline to 3.5 episodes/week; within-group difference, 1.9
episodes/week) vs the usual care group (from 1.5 episodes/
week at baseline to 2.3 episodes/week; within-group differ-
ence, 0.8 episodes/week) (between-group difference, 1.1
episodes/week [95% CI, −0.2 to 2.4 episodes/week], P = .09)
(Table 2).
Among participants in the exercise intervention group
with valid data from a wearable device throughout the inter-
vention period, there was no significant change in mean
steps per day (3945 steps/d [SD, 2689 steps/d] for days 1-60;
3744 steps/d [SD, 2698 steps/d] for days 66-126; and 3551
steps/d [SD, 2933 steps/d] for days 192-252). Between base-
line and 4½ months, the mean change was −200 steps/d
(95% CI, −594 to 194 steps/d; P = .31) and between base-
line and 9 months was −394 steps/d (95% CI, −972 to 185
steps/d; P = .18).
Primary Outcome
At 9-month follow-up, there was no significant difference for
the mean change in 6-minute walk distance for the exercise
intervention group (from 330.5 m [SD, 100.2 m] at baseline to
333.4 m [SD, 115.1 m]; within-group difference, 5.5 m) vs the
usual care group (from 336.2 m [SD, 96.6 m] at baseline to
348.2 m [SD, 98.1 m]; within-group difference, 14.4 m)

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 Research Original Investigation Effect of a Home-Based Exercise Intervention on Walking Performance in Peripheral Artery Disease

Table 1. Characteristics of Participants Randomized to Home-Based Exercise vs Usual Care

Home-Based Exercise Usual Care
(n = 99)a (n = 101)a
Age, mean (SD), y 70.1 (10.6) 70.4 (10.1)
Female sex 54 (54.5) 51 (50.5)
Black race 49 (49.5) 51 (50.5)
Abbreviation: PROMIS,
Ankle brachial index, mean (SD)b 0.65 (0.15) 0.67 (0.14) Patient-Reported Outcomes
Body mass index, mean (SD)c 29.6 (5.3) 29.9 (5.3) Measurement Information System.
a
Current or former smoker 79 (79.8) 91 (90.1) Data are expressed as No. (%)
unless otherwise indicated. Two
Myocardial infarction 16 (16.2) 21 (20.8)
participants were missing data for
Heart failure 8 (8.1) 11 (11.0) myocardial infarction, 1 was missing
Stroke 10 (10.1) 16 (15.8) data for heart failure, 1 was missing
data for the Short Form 36 physical
Angina 18 (18.2) 24 (24.0)
component score, and 2 were
Cancer 18 (18.2) 19 (18.8) missing data for the Walking
Diabetes 35 (35.4) 32 (31.7) Impairment Questionnaire distance
score at baseline.
Classic claudication symptoms 17 (17.2) 22 (21.8) b
This comparison excluded 34
Exertional leg pain other than claudication 68 (68.7) 67 (66.3) participants who were eligible based
No exertional leg symptoms 14 (14.1) 12 (11.9) on prior revascularization or other
History of lower extremity revascularization 36 (36.4) 44 (43.6) criteria and who had a baseline ankle
brachial index greater than 0.90.
6-min walk distance, mean (SD), m 331 (100) 336 (97) c
Calculated as weight in kilograms
Medical Outcomes Study Short Form 35.4 (9.4) 36.9 (9.0) divided by height in meters squared.
36 physical component summary score,
d
mean (SD)d Range: 0 to 100; a score of 100
Walking Impairment Questionnaire score, indicates the best possible score.
mean (SD)d e
Based on item response theory;
Distance 37.7 (29.5) 37.9 (27.3) therefore, these subcomponents
Speed 36.4 (19.4) 40.0 (24.5) have no defined minimum or
maximum value. The lowest and
Stair climbing 48.7 (27.2) 47.4 (27.8) highest scores observed have been
PROMIS score, mean (SD)e 20 and 80, respectively.
f
Pain interferencef 56.5 (8.4) 56.7 (7.5) A higher score indicates
a worse outcome.
Role satisfactiong 48.2 (10.0) 48.8 (10.5)
g
A higher score indicates
Mobilityg 33.3 (5.3) 33.8 (5.4)
the best outcome.

Table 2. Changes in Number of Blocks Walked and Walking Exercise Frequency During Past Week

Home-Based Exercise, Mean (SD) (n = 97) Usual Care, Mean (SD) (n = 101) Between-Group Difference
Within-Group Within-Group for Mean Change
Baseline Follow-up Differencea Baseline Follow-up Differencea From Baseline (95% CI) P Value
Distance Walked During Past Week, No. of Blocks
3-mo follow-up 17.3 (26.3) 28.8 (51.3) 11.7 (52.3) 17.5 (30.8) 22.4 (39.1) 4.9 (29.6) 6.7 (−6.3 to 19.7) .31
6-mo follow-up 17.3 (26.3) 45.6 (103.6) 28.0 (100.0) 17.5 (30.8) 21.0 (45.3) 3.6 (33.3) 24.4 (−1.2 to 49.9) .06
9-mo follow-up 17.3 (26.3) 28.7 (53.7) 11.4 (51.1) 17.5 (30.8) 24.2 (37.8) 6.7 (36.9) 4.6 (−9.2 to 18.4) .51
Walking Exercise Frequency During Past Week, No. of Episodes
3-mo follow-up 1.7 (2.9) 3.7 (2.5) 2.0 (3.7) 1.5 (2.1) 2.2 (3.0) 0.7 (2.5) 1.3 (0.4 to 2.3) .005
6-mo follow-up 1.7 (2.9) 4.3 (6.8) 2.8 (7.3) 1.5 (2.1) 2.4 (3.5) 0.9 (3.3) 1.9 (0 to 3.8) .045
9-mo follow-up 1.7 (2.9) 3.5 (4.2) 1.9 (5.0) 1.5 (2.1) 2.3 (2.9) 0.8 (2.9) 1.1 (−0.2 to 2.4) .09
a
Indicates mean change between baseline and follow-up.

(between-group difference for the mean change from base-
line to follow-up, −8.9 m [95% CI, −26.0 to 8.2 m], P = .31;
Table 3).
Secondary Outcomes
At 9-month follow-up, there was no difference in change in the
mean score for WIQ distance in the exercise intervention group
(from 38.0 [SD, 29.4] at baseline to 52.2 [SD, 33.5]; within-
group difference, 10.6) compared with the usual care group
(from 37.7 [SD, 27.1] at baseline to 46.1 [SD, 30.0]; within-
group difference, 4.8) (between-group difference for the mean
change from baseline to follow-up, 5.8 [95% CI, −3.0 to 14.7],
P = .20; Table 3).
At 9-month follow-up, the mean score for PROMIS pain
interference changed in the exercise intervention group from
56.4 (SD, 8.4) at baseline to 56.6 (SD, 9.0) (within-group dif-
ference, 0.7) vs from 56.7 (SD, 7.5) at baseline to 53.4 (SD, 8.8)
(within-group difference, −2.8) in the usual care group

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 Table 3. Effects of Home-Based Walking Exercise Intervention on Primary and Secondary Outcomesa

Home-Based Exercise (n = 97) Usual Care (n = 101)

jama.com
9-mo Within-Group 9-mo Within-Group Between-Group Difference
Baseline, Follow-up, Difference Baseline, Follow-up, Difference for Mean Change
Mean (SD) Mean (SD) (95% CI)b Mean (SD) Mean (SD) (95% CI)b From Baseline (95% CI) P Value
6-minute walk distance, m 330.5 (100.2) 333.4 (115.1) 5.5 (−8.7 to 19.7) 336.2 (96.6) 348.2 (98.1) 14.4 (0.5 to 28.3) −8.9 (−26.0 to 8.2) .31
WIQ scorec
Distance 38.0 (29.4) 52.2 (33.5) 10.6 (3.3 to 17.9) 37.7 (27.1) 46.1 (30.0) 4.8 (−2.4 to 12.0) 5.8 (−3.0 to 14.7) .20
Speed 36.7 (19.3) 41.3 (26.4) 4.1 (−1.1 to 9.2) 40.0 (24.4) 43.4 (24.4) 2.8 (−2.3 to 7.9) 1.3 (−5.0 to 7.5) .69
Stair climbing 49.2 (27.1) 52.2 (32.4) 2.5 (−3.7 to 8.7) 47.4 (27.6) 50.5 (29.4) 2.6 (−3.4 to 8.7) −0.2 (−7.6 to 7.3) .97
SF-36 physical functioning scorec 35.8 (9.4) 36.5 (10.8) 0.4 (−1.5 to 2.4) 36.9 (9.0) 39.0 (9.6) 1.8 (0 to 3.7) −1.4 (−3.7 to 1.0) .24
PROMIS scored
Pain interferencee 56.4 (8.4) 56.6 (9.0) 0.7 (−1.1 to 2.6) 56.7 (7.5) 53.4 (8.8) −2.8 (−4.6 to −1.0) 3.5 (1.3 to 5.8) .002
Role satisfactionf 48.5 (9.9) 48.2 (9.7) −0.1 (−2.4 to 2.1) 48.8 (10.4) 50.4 (10.3) 1.7 (−0.6 to 4.0) −1.8 (−4.6 to 1.0) .20
Mobilityf 33.3 (5.3) 33.0 (6.3) −0.3 (−1.3 to 0.7) 33.8 (5.3) 33.1 (5.9) −0.7 (−1.7 to 0.3) 0.4 (−0.8 to 1.7) .47
Accelerometer
No. of participants 91 91 95 95
Physical activity outcome 112 445 (67 129) 111 767 (72 263) −494 (−13 110 to 12 123) 115 069 (71 988) 112 669 (70 318) −2427 (−13 439 to 8585) 1934 (−14 872 to 18 740) .82

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b
Abbreviations: PROMIS, Patient-Reported Outcomes Measurement Information System; SF-36, Medical Indicates mean change between baseline and 9-month follow-up.
Outcomes Study Short Form 36; WIQ, Walking Impairment Questionnaire. c
Range from 0 to 100; a score of 100 indicates the best possible score.
a
Results exclude 2 participants who died prior to completing 9-month follow-up. Missing data were imputed; d
Based on item response theory; therefore, these subcomponents have no defined minimum or maximum value.
however, data for the 2 participants who died before completing 9-month follow-up were not included The lowest and highest scores observed for PROMIS have been 20 and 80, respectively.
in the imputed analyses. The data were imputed as follows: 6-minute walk distance: 21 participants e
A higher score indicates a worse outcome.
(10.6%); WIQ distance score: 21 participants (10.6%); WIQ speed score: 17 (8.6%); WIQ stair climbing score:
f
17 (8.6%); SF-36 physical functioning score: 19 (9.6%); PROMIS pain interference score: 17 (8.6%); A higher score indicates the best outcome.
Effect of a Home-Based Exercise Intervention on Walking Performance in Peripheral Artery Disease

PROMIS role satisfaction score: 17 (8.6%); PROMIS mobility score: 17 (8.6%); accelerometer measured
physical activity: 93 (50%).

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(Reprinted) JAMA April 24, 2018 Volume 319, Number 16
Original Investigation Research

1671
 Research Original Investigation Effect of a Home-Based Exercise Intervention on Walking Performance in Peripheral Artery Disease

Figure 2. Change in Response to the Home-Based Walking Exercise Intervention by Participant Characteristics

Home-Based Exercise Usual Care

Within-Group 6-min Within-Group 6-min Mean Between-
Walk Distance Change Walk Distance Change Group Difference Favors
No. of From Baseline, Mean No. of From Baseline, Mean for Change From Favors Home-Based P P Value for
Source Patients (95% CI) Patients (95% CI) Baseline (95% CI), m Usual Care Exercise Value Interaction
Age, y
≤70 50 11.1 (–13.2 to 35.3) 49 19.9 (–5.5 to 45.2) –8.8 (–36.9 to 19.3) .54
.97
>70 47 0.2 (–16.5 to 16.9) 52 9.8 (–5.4 to 25.0) –9.6 (–30.6 to 11.4) .37
Sex
Female 53 12.8 (–9.2 to 34.7) 51 24.2 (3.0 to 45.4) –11.4 (–35.3 to 12.5) .35
.81
Male 44 0.4 (–20.2 to 21.0) 50 7.5 (–11.6 to 26.5) –7.1 (–32.6 to 18.4) .58
Race
Black 48 19.9 (–28.0 to 67.8) 51 24.6 (–20.3 to 69.5) –4.7 (–30.2 to 20.7) .72
.67
Other 49 4.5 (–12.7 to 21.7) 50 17.2 (0.4 to 34.0) –12.7 (–36.7 to 11.2) .30
Ankle brachial index
≤0.60 26 –2.9 (–30.5 to 24.6) 30 17.9 (–9.8 to 45.6) –20.9 (–55.0 to 13.3) .23
.41
>0.60 71 8.6 (–8.1 to 25.3) 71 13.0 (–3.0 to 29.0) –4.4 (–24.5 to 15.6) .66
Diabetes
Yes 35 –11.1 (–33.7 to 11.5) 32 4.9 (–19.6 to 29.4) –15.9 (–44.6 to 12.7) .28
.53
No 62 14.4 (–4.0 to 32.7) 69 18.5 (1.7 to 35.2) –4.1 (–25.8 to 17.6) .71
Current smoker
Yes 26 28.7 (–3.3 to 60.8) 30 24.4 (–9.7 to 58.4) 4.4 (–28.8 to 37.5) .80
.37
No 71 –1.2 (–17.3 to 15.0) 71 11.9 (–3.5 to 27.3) –13.1 (–33.3 to 7.2) .21
6-min walk distance, m
≤ Baseline median 52 7.7 (–13.2 to 28.5) 46 18.6 (–2.6 to 39.7) –10.9 (–36.7 to 14.9) .41
.70
> Baseline median 45 2.2 (–17.4 to 21.7) 55 6.4 (–12.4 to 25.3) –4.3 (–27.7 to 19.1) .72
Classic intermittent claudication symptoms
Yes 16 1.4 (–33.4 to 36.2) 22 16.5 (–11.9 to 44.9) –15.1 (–56.8 to 26.7) .48
.82
No 81 6.9 (–10.2 to 24.1) 79 14.8 (–3.4 to 33.0) –7.9 (–27.1 to 11.3) .42
Site
Northwestern University 69 0 (–14.4 to 14.5) 72 10.5 (–3.5 to 24.4) –10.4 (–30.7 to 9.8) .31
New York University 15 9.7 (–26.0 to 45.4) 16 27.9 (–4.3 to 60.0) –18.2 (–68.0 to 31.6) .47 .63
University of Minnesota 13 10.9 (–17.9 to 39.7) 13 0.6 (–29.9 to 31.1) 10.3 (–33.8 to 54.4) .65
Overall 97 5.5 (–8.7 to 19.7) 101 14.4 (0.5 to 28.3) –8.9 (–26.0 to 8.2) .31

–75 –50 –25 0 25 50 75

Mean Between-Group Difference
for Change in 6-min Walk Distance
Between Baseline and 9-mo
Follow-up, m

(between-group difference for the mean change from base-
line to follow-up, 3.5 [95% CI, 1.3 to 5.8], P = .002), indicating
a more favorable change in the pain interference score in the
usual care group. There were no other statistically significant
differences for the secondary outcomes between the exercise
intervention group and the usual care group (Table 3).
Exploratory Analyses
At 4½-month follow-up, the mean 6-minute walk distance in
the exercise intervention group changed from 330.0 m (SD,
99.8 m) at baseline to 339.0 m (SD, 113.7 m) (within-group dif-
ference, 9.8 m) vs from 336.2 m (SD, 96.6 m) at baseline to 335.7
m (SD, 104.2 m) (within-group difference, 0 m; 95% CI, −12.6
to 12.7 m) in the usual care group (between-group difference
for the mean change from baseline to follow-up, 9.8 m [95%
CI, −6.2 to 25.7 m], P = .23). There were no statistically signifi-
cant between-group differences in the mean change from base-
line to follow-up between the exercise intervention and usual
care groups for any other outcomes at 4½-month follow-up
(eTable 1 in Supplement 2).
There were no statistically significant interactions in the
post hoc exploratory analyses for response to the exercise
intervention according to age, sex, race, severity of PAD,
baseline performance in 6-minute walk distance, study site,
diabetes, current smoking, or intermittent claudication
symptoms (Figure 2). Changes in the numbers of blocks
walked during the past week and patient-reported walking
exercise frequency per week in the post hoc exploratory
analyses were plotted by change in 6-minute walk distance
(Figure 3). There was a weak positive correlation between
change in 6-minute walk distance at 9-month follow-up and
change in patient-reported blocks walked during the past
week (Figure 3A) and change in patient-reported walking
exercise frequency per week (Figure 3B).
Adverse Events
Forty-three participants (45%) in the exercise intervention
group vs 51 (51%) in the usual care group reported more diffi-
culty than usual with exercise or activity during the trial and
45 (47%) vs 48 (48%), respectively, reported new or increas-
ing shortness of breath during activity. Fifty-five serious ad-
verse events occurred among 23 participants in the exercise
intervention group and 23 events occurred among 15 partici-
pants in the usual care group (eTable 2 in Supplement 2).

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 Effect of a Home-Based Exercise Intervention on Walking Performance in Peripheral Artery Disease Original Investigation Research

Figure 3. Change in 6-Minute Walk Distance Between Baseline and 9-Month Follow-up
According to Patient-Reported Change in Physical Activity and Frequency of Walking Exercise

A Change in 6-min walk distance at 9-mo follow-up by change in patient-reported blocks walked during past week

200

100
Change in 6-min Walk Distance Between
Baseline and 9-mo Follow-up, m

–100 Home-based exercise

Northwestern University (n = 69)
New York University (n = 15)
University of Minnesota (n = 13)
–200 Usual care
Northwestern University (n = 72)
New York University (n = 16)
University of Minnesota (n = 13)

–300
–200 –100 0 100 200 300
Change in Patient-Reported Blocks Walked During Past Week, No. of Blocks

B Change in 6-min walk distance at 9 mo follow-up by change in patient-reported walking exercise frequency per week
200

100
Change in 6-min Walk Distance Between
Baseline and 9-mo Follow-up, m

–100

–200

–300
–20 –10 0 10 20 30
Change in Patient-Reported Walking Exercise Frequency During Past Week, No. of Episodes/wk

Two deaths occurred and both were participants in the activity monitor did not improve 6-minute walk distance at
exercise intervention group. One participant died due to criti- 9-month follow-up compared with usual care. The usual care
cal limb ischemia complicated by sepsis and the other due to group reported greater improvement in PROMIS-measured
metastatic cancer. Neither was considered related to study pain interference score for daily activities compared with the
participation. Adverse event rates are reported in eTable 3 in exercise intervention group at 9-month follow-up. There
Supplement 2. were no significant differences in other secondary outcomes,
including the PROMIS mobility score, the PROMIS satisfac-
tion with social roles score, WIQ scores, quality of life, or
objectively measured physical activity levels.
Discussion Clinical practice guidelines recommend supervised
Among patients with PAD, a home-based exercise inter- treadmill exercise for patients with PAD, and clinical trials
vention of telephone coaching combined with a wearable have shown supervised treadmill exercise significantly

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 Research Original Investigation Effect of a Home-Based Exercise Intervention on Walking Performance in Peripheral Artery Disease
improves treadmill walking performance and 6-minute walk
distance. 1 ,3 - 5 However, supervised treadmill exercise
requires frequent medical center visits and such attendance
is difficult for many patients with PAD.6 Three randomized
trials demonstrated that interventions promoting walking
exercise at home, which included scheduled medical center
visits every 1 to 4 weeks throughout the intervention, sig-
nificantly improved the 6-minute walk distance by approxi-
mately 45 to 53 m, which is consistent with a large meaning-
ful change.7-9
In comparison, supervised treadmill exercise interven-
tions improved the 6-minute walk distance by only 15 to
33 m.3,4,8 Home-based exercise interventions are convenient
and accessible, and because of their large effect on 6-minute
walk distance, these types of interventions are a potentially
important treatment for patients with PAD. To our knowl-
edge, no prior randomized trials have tested a behavioral
intervention of home-based exercise among patients with
PAD in which most of the contact with the coach occurred
during telephone calls and was enhanced by a wearable
activity monitor without periodic visits to the medical center
throughout the intervention.
There are several potential explanations for the lack
of benefit from the exercise intervention in this trial.
First, for behavioral interventions, remote coaching is less
potent than in-person visits.35 Second, based on feedback
from patients, this trial used a wearable activity monitor.
However, the wearable monitor measured activity through-
out the day, whereas the intervention was designed to
increase discrete episodes of walking exercise each day. This
mismatch between the wearable device measurement and
the exercise recommendations may have encouraged par-
ticipants to increase overall activity level (which has not
been shown to improve walking endurance among patients
with PAD) rather than increase walking exercise (which has
been shown to improve walking endurance among patients
with PAD).3,4,7-9
Third, the monthly counseling via telephone calls
during the final 4½ months of the intervention may have
been too infrequent. The frequency of walking exercise
was significantly greater among participants in the exercise
intervention group than in the usual care group at 3- and
6-month follow-up; however, there was no significant dif-
ference at 9-month follow-up. Fourth, patients with PAD
who are interested in home-based exercise without med-
ical center visits throughout the intervention may be less
committed than patients who agree to participate in super-
vised exercise.
Additional characteristics of this trial should be noted. First,
the findings are consistent with a recent study of 431 healthy
people in which a wearable physical activity monitor did not
increase physical activity levels.36 In the current study, the ex-
ercise intervention did not increase the frequency or amount
of exercise at 9-month follow-up. These results are important
given the increasing number of individuals using wearable de-
vices to improve health.36
Second, the observed improvement in PROMIS-measured
pain interference among participants in the usual care group
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compared with those in the exercise intervention group may
reflect greater ischemic leg symptoms during attempts to ex-
ercise in the exercise intervention group. Observational stud-
ies suggested that some patients with PAD limit their activity
to avoid ischemic leg symptoms, which may have reduced
PROMIS-measured pain interference with daily activities in the
usual care group.10,11,37
Third, the increases in the frequency of walking exercise
per day reported by participants in the exercise intervention
group were not consistent with the activity data recorded by
the wearable device or the objective physical activity moni-
tor, suggesting that participants in the exercise intervention
group may have perceived they were exercising more than
their actual behavior. Fourth, consistent with prior observa-
tional studies and randomized trials,3,4,9,11,37 most partici-
pants with PAD in this trial did not have classic claudication
symptoms. The results did not differ according to the pres-
ence vs absence of intermittent claudication symptoms.
Fifth, the results reported herein should not be con-
strued as evidence that home-based exercise is ineffective for
patients with PAD. Behavioral interventions in randomized
clinical trials that included periodic visits to a medical center
throughout the intervention achieved large meaningful
improvements in the 6-minute walk distance among patients
with PAD.7-9 Furthermore, these prior home-based exercise
interventions achieved greater improvement in the 6-minute
walk distance than supervised exercise interventions.3,4,9
Sixth, in previous randomized trials, 6-minute walk dis-
tance declined in the control group.3,4,9 In this trial, the usual
care group reported increasing their physical activity and both
walking exercise frequency and 6-minute walk distance did
not decline. Patients randomized to usual care may have de-
cided to increase exercise on their own because they were not
receiving any active intervention such as in an attention-
control intervention.
Limitations
This study has several limitations. First, the results may not
be generalizable to participants who did not meet eligibility
criteria or who were not interested in increasing their exer-
cise activity level. Second, data on location of PAD (aorto-
iliac vs superficial femoral) were not collected.
Third, there were multiple secondary outcome measures
and no adjustment for multiple comparisons. Fourth, the
absence of immediate coach review and feedback of up-
loaded activity and exercise data may have resulted in an
insufficiently potent exercise intervention. Fifth, participants
in the exercise intervention group adhered to 79% of sched-
uled intervention telephone calls with a coach, which may
have been insufficient.
Sixth, the minimal clinically important difference for
the 6-minute walk distance has not been defined spe-
cifically for patients with PAD. Seventh, the telephone calls
every 3 months used to measure walking exercise beha-
vior in the usual care group may have been too infrequent
to measure uptake of exercise activity. Eighth, there were
substantial data missing for the objective measure of physi-
cal activity.
jama.com
 Effect of a Home-Based Exercise Intervention on Walking Performance in Peripheral Artery Disease
Conclusions
Among patients with PAD, a home-based exercise interven-
tion consisting of a wearable activity monitor and telephone
ARTICLE INFORMATION
Accepted for Publication: March 6, 2018.
Author Affiliations: Department of Medicine,
Northwestern University Feinberg School of
Medicine, Chicago, Illinois (McDermott, Hahn, Li,
Lloyd-Jones, Zhang); Department of Preventive
Medicine, Northwestern University Feinberg School
of Medicine, Chicago, Illinois (McDermott, Spring,
Lloyd-Jones, Zhao); Department of Psychiatry and
Behavioral Sciences, Northwestern University
Feinberg School of Medicine, Chicago, Illinois
(Spring); Weinberg College of Arts and Sciences,
Northwestern University, Evanston, Illinois (Spring);
Department of Preventative Cardiology, New York
University School of Medicine, New York, New York
(Berger); Center for Aging Science and Care
Innovation, University of Minnesota School of
Nursing, Minneapolis (Treat-Jacobson); Division of
Vascular and Endovascular Surgery, Department of
Surgery, University of California, San Francisco
(Conte); Department of Vascular Medicine,
Dartmouth-Hitchcock Medical Center,
Dartmouth Geisel School of Medicine, Hanover,
New Hampshire (Creager); Division of Preventive
Medicine, Department of Family Medicine and
Public Health, University of California, San Diego
(Criqui); Division of Intramural Research, National
Institute on Aging, Baltimore, Maryland (Ferrucci);
Department of Cardiovascular Medicine, Cleveland
Clinic Lerner College of Medicine, Case Western
Reserve University, Cleveland, Ohio (Gornik);
Department of Epidemiology, University of
Maryland, Baltimore (Guralnik); Department of
Surgery, University of Michigan, Ann Arbor (Henke);
Department of Surgery, University of North
Carolina School of Medicine, Chapel Hill (Kibbe);
Department of Cardiology and Cardiovascular
Medicine, Duke University, Durham, North Carolina
(Kohlman-Trighoff); Department of Cardiovascular
and Thoracic Surgery, Rush University Medical
Center, Chicago, Illinois (McCarthy); Department of
Medicine, University of Chicago Medical School,
Chicago, Illinois (Polonsky); Department of Surgery,
University of Chicago Medical School, Chicago,
Illinois (Skelly); Department of Health Research and
Policy, Stanford University, Stanford, California
(Tian); Department of Health and Exercise Science,
Wake Forest University School of Medicine,
Winston-Salem, North Carolina (Rejeski).
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-Trighoff, Li, Lloyd-Jones, McCarthy,
Polonsky, Skelly, Tian, Zhao, Zhang, Rejeski.
Drafting of the manuscript: McDermott, Hahn, Li,
Tian, Zhang.
jama.com
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coaching, compared with usual care, did not improve walk-
ing 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.
Critical revision of the manuscript for important
intellectual content: McDermott, Spring, Berger,
Treat-Jacobson, Conte, Creager, Criqui, Ferrucci,
Gornik, Guralnik, Hahn, Henke, Kibbe,
Kohlman-Trighoff, 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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Cardiology/American Heart Association Task Force
on Clinical Practice Guidelines [published correction
appears in Circulation. 2017;135(12):e791-e792].
Circulation. 2017;135(12):e726-e779.
(Reprinted) JAMA April 24, 2018 Volume 319, Number 16
Original Investigation Research
2. McDermott MM, Kibbe MR. Improving lower
extremity functioning in peripheral artery disease:
exercise, endovascular revascularization, or both?
JAMA. 2017;317(7):689-690.
3. McDermott MM, Ferrucci L, Tian L, et al. Effect
of granulocyte-macrophage colony-stimulating
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artery disease: the PROPEL randomized clinical
trial. JAMA. 2017;318(21):2089-2098.
4. McDermott MM, Ades P, Guralnik JM, et al.
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