Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale.
BACKGROUND
Although there are limited clinical data to support the use of exercise training as a means to reduce mortality and morbidity in patients with heart failure, current guidelines state that exercise is beneficial.


METHODS
The objective of this trial is to determine whether exercise training reduces all-cause mortality or all-cause hospitalization for patients with left ventricular systolic dysfunction and heart failure symptoms. After undergoing baseline assessments to determine whether they can safely exercise, patients are randomized to either usual care or exercise training. Patients in the exercise training arm attend 36 supervised facility-based exercise training sessions. Exercise modalities are cycling or walking. After completing 18 sessions, patients initiate home-based exercise and then transition to solely home-based exercise after completing all 36 sessions. Patients return for facility-based training every 3 months to reinforce their exercise training program. Patients are followed for up to 4 years. Physiologic, quality-of-life, and economic end points that characterize the effect of exercise training in this patient population will be measured at baseline and at intervals throughout the trial. Blood samples will be collected to examine biomarkers such as brain natriuretic peptide, tumor necrosis factor, and C-reactive protein.


CONCLUSIONS
Because of its relatively low cost, high availability, and ease of use, exercise training is an intervention that could be accessible to most patients with heart failure. The HF-ACTION trial is designed to definitively assess the effect of exercise training on the clinically relevant end points of mortality, hospitalization, and quality of life in patients with heart failure.
Whellan
David J
DJ
Department of Medicine, Jefferson Medical College, Philadelphia, PA 19107, USA. david.whellan@jefferson.edu
O'Connor
Christopher M
CM
Lee
Kerry L
KL
Keteyian
Steven J
SJ
Cooper
Lawton S
LS
Ellis
Stephen J
SJ
Leifer
Eric S
ES
Kraus
William E
WE
Kitzman
Dalane W
DW
Blumenthal
James A
JA
Rendall
David S
DS
Houston-Miller
Nancy
N
Fleg
Jerome L
JL
Schulman
Kevin A
KA
Piña
Ileana L
IL
D005081:Exercise Therapy; D005260:Female; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D008297:Male; D012107:Research Design; D016896:Treatment Outcome