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Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial
Flynn KE, Pina IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP
JAMA 2009 Apr 8;301(14):1451-1459
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

CONTEXT: Findings from previous studies of the effects of exercise training on patient-reported health status have been inconsistent. OBJECTIVE: To test the effects of exercise training on health status among patients with heart failure. DESIGN, SETTING, AND PATIENTS: Multicenter, randomized controlled trial among 2,331 medically stable outpatients with heart failure with left ventricular ejection fraction of 35% or less. Patients were randomized from April 2003 through February 2007. INTERVENTIONS: Usual care plus aerobic exercise training (n = 1,172), consisting of 36 supervised sessions followed by home-based training, versus usual care alone (n = 1,159). Randomization was stratified by heart failure etiology, which was a covariate in all models. MAIN OUTCOME MEASURES: Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scale and key subscales at baseline, every 3 months for 12 months, and annually thereafter for up to 4 years. The KCCQ is scored from 0 to 100 with higher scores corresponding to better health status. Treatment group effects were estimated using linear mixed models according to the intention-to-treat principle. RESULTS: Median follow-up was 2.5 years. At 3 months, usual care plus exercise training led to greater improvement in the KCCQ overall summary score (mean 5.21; 95% confidence interval 4.42 to 6.00) compared with usual care alone (3.28; 95% confidence interval 2.48 to 4.09). The additional 1.93-point increase (95% confidence interval 0.84 to 3.01) in the exercise training group was statistically significant (p < 0.001). After 3 months, there were no further significant changes in KCCQ score for either group (p = 0.85 for the difference between slopes), resulting in a sustained, greater improvement overall for the exercise group (p < 0.001). Results were similar on the KCCQ subscales, and no subgroup interactions were detected. CONCLUSIONS: Exercise training conferred modest but statistically significant improvements in self-reported health status compared with usual care without training. Improvements occurred early and persisted over time. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00047437.

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