Enhancing standard cardiac rehabilitation with stress management training: background, methods, and design for the enhanced study

Abstract

Purpose: Enhancing Standard Cardiac Rehabilitation with Stress Management Training in Patients with Heart Disease (ENHANCED) is a randomized clinical trial funded by the National Heart Lung and Blood Institute to evaluate the effects of stress management training (SMT) on changes in biomarkers of risk and quality of life for patients enrolled in traditional exercise-based cardiac rehabilitation (CR).

Methods: One hundred fifty cardiac patients recruited from Duke University and the University of North Carolina will be evaluated and randomized to CR enhanced by SMT (including sessions devoted to relaxation training, cognitive restructuring, communication skills, and problem solving) or to standard exercise-based CR. Before and after 12 weeks of treatment, patients will undergo a battery of psychometric questionnaires and evaluation of cardiovascular biomarkers, including measures of flow-mediated dilation, heart rate variability, baroreflex sensitivity, platelet function and inflammation, and ischemia during laboratory mental stress testing. The primary outcomes include a composite measure of stress (distress, depression, anxiety, and hostility and 24-hour urinary catecholamines and cortisol) and a composite measure of cardiac biomarkers of risk (vascular endothelial function, cardiac vagal control, inflammation, platelet function, and mental stress-induced myocardial ischemia). Secondary outcomes include measures of quality of life as well as clinical events, including death, hospitalizations, myocardial infarction, and revascularization procedures.

Results: This article reviews prior studies in the area and describes the design of the ENHANCED study. Several key methodological issues are discussed including the assessment of biomarkers of risk and barriers to the integration of SMT into traditional CR.

Conclusions: The ENHANCED study will provide important information by determining to what extent SMT combined with exercise-based CR may improve prognosis and quality of life in vulnerable cardiac patients.

Figure 1

The proposed investigation involves (1) a careful screening of potential participants; (2) a thorough pre-treatment assessment of stress and biomarkers of risk; (3) a randomized clinical trial of cardiac rehabilitation alone and Stress Management Trteatment (SMT)-enhanced cardiac rehabilitation; (4) post-treatment assessment of the impact of the 3-month intervention on cardiovascular biomarkers and quality of life; and (5) follow-up in which we plan to follow all participants for at least 6 months and up to 4 years (median 30 months) to assess clinical events including myocardial infarction, death, and cardiac-related hospitalizations.