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Purpose: Cardiac rehabilitation programs (CRPs) remain un- myocardial infarction.1–5 Despite current recommendations,6
derutilized partly because of access barriers. We therefore eval- CRPs are vastly underused, with as little as one-third of el-
uated a CRP with fewer center-based sessions (rCRP) compared igible patients participating.7 This is due to transportation
with standard CRP (sCRP) with respect to changes in exercise issues, financial cost, and time constraints.7–9 Furthermore,
capacity and cardiac risk factors. the standard CRP often treats a wide variety of cardiovascu-
Methods: In this randomized controlled noninferiority trial, lar patients, from low- to high-risk patients in a “1-size fits
primary and secondary prevention patients at low and moderate all” fashion, without triaging on the basis of disease severity.
risk were randomized to an sCRP (n = 60) or an rCRP (n = In an attempt to overcome CRP utilization barriers, alter-
61). Over 4 months, sCRP and rCRP participants attended 32 native programs with fewer CRP sessions have been devel-
and 10 on-site cardiac rehabilitation sessions, respectively. The oped and compared with center-based programs.10–12 How-
primary outcome was the difference in the change in exercise ever, many of these included only low-risk patients, focused
capacity from baseline at 4 and 16 months between the groups only on exercise, and utilized resources that are not usually
measured in seconds from a maximal treadmill exercise test. provided by CRPs such as home exercise equipment and
Noninferiority of the rCRP was tested with mixed-effects model supervised home training. Importantly, these studies lacked
analysis with a cut point of 60 seconds for the upper value of follow-up after intervention completion and were designed as
the group estimate. superiority trials in which a nonsignificant test could wrong-
Results: Attendance was higher for the rCRP group (97% ± ly be interpreted as proof of no difference between groups.13
63% vs 71% ± 22%, P = .002). Over 16 months, exercise test To overcome these gaps, we designed a comprehensive CRP
time increased for the sCRP (524 ± 168 to 604 ± 172 seconds, with fewer center-based supervised sessions (rCRP) to eval-
P < .01) and the rCRP (565 ± 183 to 640 ± 192 seconds, P < uate and compare its effectiveness with the standard CRP
.01). The rCRP was not inferior to the sCRP regarding changes (sCRP) in primary and secondary prevention patients using
in treadmill time (48.47 seconds, P = .454). The rCRP was not a noninferiority single-blinded randomized controlled trial.
inferior to the sCRP regarding metabolic and anthropometric We hypothesized that the rCRP was noninferior to the sCRP
risk factors. for changes in total time on a treadmill exercise test and risk
Conclusion: Our findings suggest that, for a selected group of factors at program completion (4 months) and at 1 year of
low-/moderate-risk patients, the number of center-based CRP follow-up from program graduation (16 months).
exercise sessions can be decreased while maintaining reduced
cardiovascular risk factors.
Key Words: cardiac rehabilitation • cardiovascular disease METHODS
prevention • exercise • risk factors This study was a prospective, 2-group noninferiority
randomized controlled trial. Consecutive patients were
C ardiac rehabilitation programs (CRPs) provide compre-
hensive management of patients with, and at risk for,
cardiovascular disease.1–4 Evidence has shown that CRPs
screened during the CRP intake clinic at St Paul’s Hospi-
tal, Vancouver, British Columbia, Canada, a tertiary care
center. Primary and secondary prevention patients at low
decrease all-cause and cardiovascular mortality by 20% and moderate risk according to the American Association
and 26%, respectively, as well as reducing risk of recurrent of Cardiovascular and Pulmonary Rehabilitation risk strat-
ification criteria14 were eligible (ejection fraction ≥40%,
Author Affiliations: Department of Biomedical Physiology and Kinesiology absence of rest or exercise-induced complex arrhythmias
(Drs Farias-Godoy, Claydon, and Lear) and Faculty of Health Sciences or ischemia, functional capacity ≥5 metabolic equivalents
(Ms Mendell and Dr Lear), Simon Fraser University, Burnaby, British Columbia, (METs), and normal exercise hemodynamics). Patients
Canada; Division of Cardiology, Providence Health Care, Healthy Heart were excluded if they had clinical congestive heart failure,
Program, St Paul’s Hospital, Vancouver, British Columbia, Canada (Drs Chan,
ejection fraction <40%, complex comorbid conditions
Ignaszewski, Singer, and Lear); School of Population and Public Health,
University of British Columbia, Vancouver, Canada (Ms Park and Dr Singer).
(poorly controlled diabetes or chronic kidney disease), cog-
nitive impairment, scheduled revascularization, depression,
All authors have read and approved the article.
or no understanding of the English language. This study
The authors declare no conflicts of interest. was approved by the Providence Health Care and Simon
Correspondence: Scott A. Lear, PhD, Healthy Heart Program, St Paul’s Fraser University research ethics boards. All participants
Hospital, 180-1081 Burrard St, Vancouver, BC V6Z 1Y6, Canada (slear@ provided written informed consent.
providencehealth.bc.ca). Potential participants were approached after the CRP
Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved. intake assessment. Consenting participants were strati-
DOI: 10.1097/HCR.0000000000000269 fied by gender and randomized to either the sCRP or the
Figure 1. Diagram of study design. rCRP indicates reduced cardiac rehabilitation program; sCRP, standard cardiac rehabilitation program.
Figure 2. Flow diagram of study participants through different phases of enrollment, allocation, follow-up, and analysis. CRP indicates cardiac
rehabilitation program.
In addition, some of these studies provided costly home ex- and participated in more physical activity than those in a
ercise equipment, focused only on low-risk patients, were 6-month center-based program at 1-year follow-up.28 Al-
limited to exercise-only interventions, and conducted no though in our study treadmill time and physical activity lev-
follow-up after the intervention. Our study addressed these els were comparable between the 2 groups, patients in the
gaps and demonstrated that a CRP with 10 center-based sCRP experienced a decline in total treadmill time after 1
exercise sessions was as effective as the standard CRP in year that was not observed in the rCRP patients.
modifying cardiac risk factors immediately after completion Program adherence measured as attendance to scheduled
and for 1 year after in low- and moderate-risk patients. center-based CR was higher for the rCRP group (84% vs
As for sustainability of results, we are aware of 1 study 71.5%, P < .01). This could be explained by the rCRP be-
that found that participants in a 6-month home-based ing less time-consuming, requiring less transportation and
exercise program achieved a greater exercise capacity hospital time. This is consistent with the literature as many
CRP participants perceive the effort to attend center-based
sessions as a barrier for participation and adherence.29 The
decreased center-based number of CR sessions, however,
did not translate into reduced self-reported physical activ-
ity at program completion and at 1-year follow-up. This
positive change was not significantly different between the
groups. These findings are consistent with Carlson et al,30
who reported no difference in physical activity between
a home and center-based group at program completion
(3.8 ± 1.3 vs 4.3 ± 1.2 exercise sessions per week, respec-
tively; P > .05).
Although observational studies introduce inherent bias,
some have reported a positive association between CRP
“dose” and survival in secondary prevention patients.31-33
Our findings do not contradict these reports. The reduction
in center-based time was not a reduction of CRP “dose,” as
rCRP participants were encouraged to exercise and self-man-
age modifiable risk factors outside the hospital setting, while
still being supervised by the CRP staff. Indeed, we performed
subanalyses that showed no significant correlation between
center-based session attendance and exercise capacity change
Figure 3. Total treadmill time in seconds for the sCRP and rCRP groups in either group (r = 0.161, P ≥ .05) (data not shown).
at baseline, 4, and 16 months. Closed circles denote the sCRP and The results of this study have important implications for
open circles denote the rCRP. aSignificant differences from baseline. the delivery of CRP services. Traditional programs have
b
Significant difference between 4 and 16 months in the sCRP group.
accessibility challenges: extended travel time,7 low intake ca-
Significance indicators above the plot refer to the rCRP data and below
the plot to the sCRP data. rCRP indicates reduced cardiac rehabilitation
pacity, and increased cost.34 Although the number patients
program; sCRP, standard cardiac rehabilitation program. with cardiovascular disease who survive their coronary
events increases, CR availability has not and it continues to