ACTION - A CHF Trial Investigating Outcomes of Exercise

  • Pina, Ileana L. (PI)

Project: Research project

Project Details

Description

DESCRIPTION (provided by applicant):
The primary aim of the ACTION Trial is to determine the long-term safety and
effectiveness of exercise training for New York Heart Association Classes II-IV
congestive heart failure patients in addition to standard of care versus a
strategy of standard care alone. The secondary objective is to determine the
incidence and significance of exercise-related complications, the effect on
exercise tolerance and quality of life, and the cost-effectiveness of
training. The exercise training will include 36 facility-based training sessions
followed by home-based exercise and interval facility sessions. Training will
be at 60-70% of heart rate reserve. Patients randomized to the training arm
will train by either walking or bicycle ergometers. Treadmills or exercise
bicycles will be provided to training patients by the coordinating center, if
desired. Effectiveness will be defined as the primary combined endpoint of
all-cause mortality and all-cause hospitalizations. The expected annual baseline rate is 30% for the control group. The expected
non-adherence and drop-out rate is 35% the first year and 15% annually
thereafter, with a cross-over rate of 5% per year. The regional center team
and the coordinating center will implement multiple strategies to improve
adherence in patients in the training arm. Using these assumptions, a total
sample size of 3000 subjects will be required to detect a 20% reduction in the
primary outcome with an alpha level of 0.05 and a power greater than 80%. If
the non-adherence and drop-out rate decrease to 30% in the first year and
12.5% annually thereafter, the power to detect a 20% difference is greater
than 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; and
6 months for close out, analysis, and presentation.
StatusFinished
Effective start/end date9/30/026/30/10

ASJC

  • Medicine(all)