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Randomized Controlled Trial
. 2016 Apr 5;133(14):1341-50.
doi: 10.1161/CIRCULATIONAHA.115.018926. Epub 2016 Mar 21.

Enhancing Cardiac Rehabilitation With Stress Management Training: A Randomized, Clinical Efficacy Trial

James A Blumenthal  1 , Andrew Sherwood  2 , Patrick J Smith  2 , Lana Watkins  2 , Stephanie Mabe  2 , William E Kraus  2 , Krista Ingle  2 , Paula Miller  2 , Alan Hinderliter  2
Affiliations
Randomized Controlled Trial

Enhancing Cardiac Rehabilitation With Stress Management Training: A Randomized, Clinical Efficacy Trial

James A Blumenthal et al. Circulation. .

Abstract

Background: Cardiac rehabilitation (CR) is the standard of care for patients with coronary heart disease. Despite considerable epidemiological evidence that high stress is associated with worse health outcomes, stress management training (SMT) is not included routinely as a component of CR.

Methods and results: One hundred fifty-one outpatients with coronary heart disease who were 36 to 84 years of age were randomized to 12 weeks of comprehensive CR or comprehensive CR combined with SMT (CR+SMT), with assessments of stress and coronary heart disease biomarkers obtained before and after treatment. A matched sample of CR-eligible patients who did not receive CR made up the no-CR comparison group. All participants were followed up for up to 5.3 years (median, 3.2 years) for clinical events. Patients randomized to CR+SMT exhibited greater reductions in composite stress levels compared with those randomized to CR alone (P=0.022), an effect that was driven primarily by improvements in anxiety, distress, and perceived stress. Both CR groups achieved significant, and comparable, improvements in coronary heart disease biomarkers. Participants in the CR+SMT group exhibited lower rates of clinical events compared with those in the CR-alone group (18% versus 33%; hazard ratio=0.49; 95% confidence interval, 0.25-0.95; P=0.035), and both CR groups had lower event rates compared with the no-CR group (47%; hazard ratio=0.44; 95% confidence interval, 0.27-0.71; P<0.001).

Conclusions: CR enhanced by SMT produced significant reductions in stress and greater improvements in medical outcomes compared with standard CR. Our findings indicate that SMT may provide incremental benefit when combined with comprehensive CR and suggest that SMT should be incorporated routinely into CR.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00981253.

Keywords: coronary disease; epidemiology; exercise; rehabilitation; stress, psychological.

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Figures

Figure 1
Figure 1
Participant flow in the ENHANCED (Enhancing Standard Cardiac Rehabilitation with Stress Management Training in Patients with Coronary Heart Disease) clinical trial. CR = Cardiac Rehabilitation; CR+SMT = Cardiac Rehabilitation Enhanced with Stress Management Training; ITT = intention-to-treat.
Figure 2
Figure 2
Cumulative time-to-event curves for clinical events in the CR+SMT, CR-alone, and No-CR groups. Clinical events included all-cause mortality, myocardial infarction, cardiac or peripheral vascular intervention, stroke/TIA, or unstable angina requiring hospitalization. Participants in the CR+SMT were at significantly lower risk of clinical events compared with the CR-alone group (HR= 0.47 [0.24, 0.91], P = 0.025). Both CR groups had lower event rates compared with a non-randomized, matched No-CR control group (HR = 0.35 [0.22, 0.56], P < .001). Number at risk represents participants with follow-up data for clinical events who had not yet had an event at years 0, 2, and 4.
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