The primary aim of the ACTION Trial is to determine the long-term safety andeffectiveness of exercise training for New York Heart Association Classes II-IVcongestive heart failure patients in addition to standard of care versus astrategy of standard care alone. The secondary objective is to determine theincidence and significance of exercise-related complications, the effect onexercise tolerance and quality of life, and the cost-effectiveness oftraining.The exercise training will include 36 facility-based training sessionsfollowed by home-based exercise and interval facility sessions. Training willbe at 60-70% of heart rate reserve. Patients randomized to the training armwill train by either walking or bicycle ergometers. Treadmills or exercisebicycles will be provided to training patients by the coordinating center, ifdesired. Effectiveness will be defined as the primary combined endpoint ofall-cause mortality and all-cause hospitalizations.The expected annual baseline rate is 30% for the control group. The expectednon-adherence and drop-out rate is 35% the first year and 15% annuallythereafter, with a cross-over rate of 5% per year. The regional center teamand the coordinating center will implement multiple strategies to improveadherence in patients in the training arm. Using these assumptions, a totalsample size of 3000 subjects will be required to detect a 20% reduction in theprimary outcome with an alpha level of 0.05 and a power greater than 80%. Ifthe non-adherence and drop-out rate decrease to 30% in the first year and12.5% annually thereafter, the power to detect a 20% difference is greaterthan 90%. The primary analysis will be based on intent-to-treat.The trial will take place over 5 years with an initial 6 months for planning,training, and implementation; 3 years of enrollment; 1 year of follow-up; and6 months for close out, analysis, and presentation.
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