Context: Observational studies have shown that psychosocial factors are associated with increased risk for cardiovascular morbidity and mortality, but the effects of behavioral interventions on psychosocial and medical end points remain uncertain. Objective: To determine the effect of 2 behavioral programs, aerobic exercise training and stress management training, with routine medical care on psychosocial functioning and markers of cardiovascular risk. Design, Setting, and Patients: Randomized controlled trial of 134 patients(92 male and 42 female; aged 40-84 years) with stable ischemic heart disease(IHD) and exercise-induced myocardial ischemia. Conducted from January 1999 to February 2003. Interventions: Routine medical care(usual care); usual care plus supervised aerobic exercise training for 35 minutes 3 times per week for 16 weeks; usual care plus weekly 1.5-hour stress management training for 16 weeks. Main Outcome Measures: Self-reported measures of general distress(General Health Questionnaire GHQ ) and depression(Beck Depression Inventory BDI ); left ventricular ejection fraction(LVEF) and wall motion abnormalities(WMA); flow-mediated dilation; and cardiac autonomic control(heart rate variability during deep breathing and baroreflex sensitivity). Results: Patients in the exercise and stress management groups had lower mean(SE) BDI scores(exercise: 8.2 0.6 ; stress management: 8.2 0.6 ) vs usual care(10.1 0.6 ; P=.02); reduced distress by GHQ scores(exercise: 56.3 0.9 ; stress management: 56.8 0.9 ) vs usual care(53.6 0.9 ; P=.02); and smaller reductions in LVEF during mental stress testing(exercise:-0.54% 0.44% ; stress management:-0.34% 0.45% ) vs usual care(-1.69% 0.46% ; P=.03). Exercise and stress management were associated with lower mean(SE) WMA rating scores(exercise: 0.20 0.07 ; stress management: 0.10 0.07 ) in a subset of patients with significant stress-induced WMA at baseline vs usual care(0.36 0.07 ; P=.02). Patients in the exercise and stress management groups had greater mean(SE) improvements in flow-mediated dilation(exercise: mean SD , 5.6% 0.45% ; stress management: 5.2% 0.47% ) vs usual care patients(4.1 % 0.48% ; P=.03). In a subgroup, those receiving stress management showed improved mean(SE) baroreflex sensitivity(8.2 0.8 ms/mmHg) vs usual care(5.1 0.9 ms/mmHg; P=.02) and significant increases in heart rate variability(193.7 19.6 ms) vs usual care(132.1 21.5 ms; P=.04). Conclusion: For patients with stable IHD, exercise and stress management training reduced emotional distress and improved markers of cardiovascular risk more than usual medical care alone.
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