Effects of exercise training on depressive symptoms in patients with chronic heart failure: the HF-ACTION randomized trial - PubMed (original) (raw)

Randomized Controlled Trial

Effects of exercise training on depressive symptoms in patients with chronic heart failure: the HF-ACTION randomized trial

James A Blumenthal et al. JAMA. 2012.

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Abstract

Context: Depression is common in patients with cardiac disease, especially in patients with heart failure, and is associated with increased risk of adverse health outcomes. Some evidence suggests that aerobic exercise may reduce depressive symptoms, but to our knowledge the effects of exercise on depression in patients with heart failure have not been evaluated.

Objective: To determine whether exercise training will result in greater improvements in depressive symptoms compared with usual care among patients with heart failure.

Design, setting, and participants: Multicenter, randomized controlled trial involving 2322 stable patients treated for heart failure at 82 medical clinical centers in the United States, Canada, and France. Patients who had a left ventricular ejection fraction of 35% or lower, had New York Heart Association class I to IV heart failure, and had completed the Beck Depression Inventory II (BDI-II) score were randomized (1:1) between April 2003 and February 2007. Depressive scores ranged from 0 to 59; scores of 14 or higher are considered clinically significant.

Interventions: Participants were randomized either to supervised aerobic exercise (goal of 90 min/wk for months 1-3 followed by home exercise with a goal of ≥120 min/wk for months 4-12) or to education and usual guideline-based heart failure care.

Main outcome measures: Composite of death or hospitalization due to any cause and scores on the BDI-II at months 3 and 12.

Results: Over a median follow-up period of 30 months, 789 patients (68%) died or were hospitalized in the usual care group compared with 759 (66%) in the aerobic exercise group (hazard ratio [HR], 0.89; 95% CI, 0.81 to 0.99; P = .03). The median BDI-II score at study entry was 8, with 28% of the sample having BDI-II scores of 14 or higher. Compared with usual care, aerobic exercise resulted in lower mean BDI-II scores at 3 months (aerobic exercise, 8.95; 95% CI, 8.61 to 9.29 vs usual care, 9.70; 95% CI, 9.34 to 10.06; difference, -0.76; 95% CI,-1.22 to -0.29; P = .002) and at 12 months (aerobic exercise, 8.86; 95% CI, 8.67 to 9.24 vs usual care, 9.54; 95% CI, 9.15 to 9.92; difference, -0.68; 95% CI, -1.20 to -0.16; P = .01).

Conclusions: Compared with guideline-based usual care, exercise training resulted in a modest reduction in depressive symptoms, although the clinical significance of this improvement is unknown.

Trial registration: clinicaltrials.gov Identifier: NCT00047437.

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Figures

Figure 1

Figure 1

Flow of participants through trial.

Figure 2

Figure 2

Nonlinear association between self-reported weekly minutes of exercise (from months 9-12) and BDI-II scores at 12 months, adjusted for gender, age, race, smoking status, blood urea nitrogen, LVEF, NYHA class, hypertension, diabetes, six minute walk distance, Weber score, Kansas City Cardiomyopathy Questionnaire score (21), site, beta blockade dose, and mitral valve regurgitation, ventricular conduction status, use of any antidepressant medication, baseline BDI-II scores, and BDI-II scores at 3 months. The weekly minutes term in the model was fitted using a 3-knot restricted cubic spline. The analysis is limited to participants in the AE condition only and with complete BDI-II data at 12 months (N = 629). Fitted line is for a typical participant (median of continuous covariates, most prevalent class for categorical variables). Shaded area represents 95% CI and hatch marks represent case density, with each dot representing a case. Some density dots extend beyond x-axis range in order to display the cases more clearly. Comparing a participant who reported 90 minutes of exercise per week to a participant who reported 0 minutes per week revealed a regression coefficient of −1.67 (95% CI = −2.62, −0.73).

Figure 3

Figure 3

Unadjusted Kaplan-Meier curves for time to composite endpoint (all-cause death or first all-cause hospitalization). Curves represent sample stratified on treatment group assignment (blue = Aerobic Exercise, red = Usual Care) and depressive symptom severity category (solid line = BDI-II < 14, dashed line = BDI-II ≥ 14). The number at risk for each group is displayed across the bottom of the plot.

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