| Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. | |
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MedLine Citation:
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PMID: 19351941 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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CONTEXT: Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure. Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes. OBJECTIVE: To test the efficacy and safety of exercise training among patients with heart failure. DESIGN, SETTING, AND PATIENTS: Multicenter, randomized controlled trial of 2331 medically stable outpatients with heart failure and reduced ejection fraction. Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) were randomized from April 2003 through February 2007 at 82 centers within the United States, Canada, and France; median follow-up was 30 months. INTERVENTIONS: Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone. MAIN OUTCOME MEASURES: Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or heart failure hospitalization. RESULTS: The median age was 59 years, 28% were women, and 37% had New York Heart Association class III or IV symptoms. Heart failure etiology was ischemic in 51%, and median left ventricular ejection fraction was 25%. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. A total of 759 patients (65%) in the exercise training group died or were hospitalized compared with 796 patients (68%) in the usual care group (hazard ratio [HR], 0.93 [95% confidence interval {CI}, 0.84-1.02]; P = .13). There were nonsignificant reductions in the exercise training group for mortality (189 patients [16%] in the exercise training group vs 198 patients [17%] in the usual care group; HR, 0.96 [95% CI, 0.79-1.17]; P = .70), cardiovascular mortality or cardiovascular hospitalization (632 [55%] in the exercise training group vs 677 [58%] in the usual care group; HR, 0.92 [95% CI, 0.83-1.03]; P = .14), and cardiovascular mortality or heart failure hospitalization (344 [30%] in the exercise training group vs 393 [34%] in the usual care group; HR, 0.87 [95% CI, 0.75-1.00]; P = .06). In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics, the HRs were 0.89 (95% CI, 0.81-0.99; P = .03) for all-cause mortality or hospitalization, 0.91 (95% CI, 0.82-1.01; P = .09) for cardiovascular mortality or cardiovascular hospitalization, and 0.85 (95% CI, 0.74-0.99; P = .03) for cardiovascular mortality or heart failure hospitalization. Other adverse events were similar between the groups. CONCLUSIONS: In the protocol-specified primary analysis, exercise training resulted in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points. After adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00047437. |
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Authors:
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Christopher M O'Connor; David J Whellan; Kerry L Lee; Steven J Keteyian; Lawton S Cooper; Stephen J Ellis; Eric S Leifer; William E Kraus; Dalane W Kitzman; James A Blumenthal; David S Rendall; Nancy Houston Miller; Jerome L Fleg; Kevin A Schulman; Robert S McKelvie; Faiez Zannad; Ileana L Piña; |
Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural |
Journal Detail:
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Title: JAMA : the journal of the American Medical Association Volume: 301 ISSN: 1538-3598 ISO Abbreviation: JAMA Publication Date: 2009 Apr |
Date Detail:
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Created Date: 2009-04-08 Completed Date: 2009-04-14 Revised Date: 2012-05-17 |
Medline Journal Info:
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Nlm Unique ID: 7501160 Medline TA: JAMA Country: United States |
Other Details:
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Languages: eng Pagination: 1439-50 Citation Subset: AIM; IM |
Affiliation:
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Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, USA. oconn002@mc.duke.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00047437 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Ambulatory Care Chronic Disease Exercise Exercise Therapy* / adverse effects Female Heart Failure / mortality, rehabilitation* Hospitalization Humans Male Middle Aged Prognosis Quality of Life Self Care |
| Grant Support | |
ID/Acronym/Agency:
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5U01HL063747/HL/NHLBI NIH HHS; 5U01HL064250/HL/NHLBI NIH HHS; 5U01HL064257/HL/NHLBI NIH HHS; 5U01HL064264/HL/NHLBI NIH HHS; 5U01HL064265/HL/NHLBI NIH HHS; 5U01HL066461/HL/NHLBI NIH HHS; 5U01HL066482/HL/NHLBI NIH HHS; 5U01HL066491/HL/NHLBI NIH HHS; 5U01HL066494/HL/NHLBI NIH HHS; 5U01HL066497/HL/NHLBI NIH HHS; 5U01HL066501/HL/NHLBI NIH HHS; 5U01HL068973/HL/NHLBI NIH HHS; 5U01HL068980/HL/NHLBI NIH HHS; R37 AG018915/AG/NIA NIH HHS; U01 HL063747-06S1/HL/NHLBI NIH HHS; U01 HL064250-06/HL/NHLBI NIH HHS; U01 HL064257-01A2/HL/NHLBI NIH HHS; U01 HL064264-05/HL/NHLBI NIH HHS; U01 HL064265-04/HL/NHLBI NIH HHS; U01 HL066461-06S1/HL/NHLBI NIH HHS; U01 HL066482-04/HL/NHLBI NIH HHS; U01 HL066491-06/HL/NHLBI NIH HHS; U01 HL066494-04/HL/NHLBI NIH HHS; U01 HL066497-04/HL/NHLBI NIH HHS; U01 HL066501-06/HL/NHLBI NIH HHS; U01 HL068973-06/HL/NHLBI NIH HHS; U01 HL068980-05/HL/NHLBI NIH HHS |
| Investigator | |
Investigator/Affiliation:
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Christopher M O'Connor / ; Kerry L Lee / ; Stephen J Ellis / ; David S Rendall / ; David J Whellan / ; Ileana L Piña / ; Steven J Keteyian / ; Lawton S Cooper / ; Robin Boineau / ; Lawrence J Fine / ; Jerome L Fleg / ; Eric S Leifer / ; Virginia Erickson / ; Jonathan G Howlett / ; Nancy Houston Miller / ; Debra Isaac / ; Robert McKelvie / ; Faiez Zannad / ; Sharon Boozer / ; Patty Connolly / ; Anthony Doll / ; Stephen J Ellis / ; Camille Frazier / ; Deb Mark / ; Michelle McClanahan-Crowder / ; Marcia Meyer / ; Brenda S Mickley / ; David S Rendall / ; Molly Rich / ; Hoss Rostami / ; Sharon Settles / ; Kathy Spinella / ; Jessica Staib / ; Omar Thompson / ; William Abraham / ; Danuta Biniakiewicz / ; Joann Homan / ; Vera Bittner / ; Meredith Fitz-Gerald / ; Gregory Ewald / ; Heidi Craddock / ; Jean Flanagan / ; Gregg Fonarow / ; Virginia Erickson / ; Wilson Colucci / ; Nancy Z Lim / ; Elena Tokareva / ; Rami Alharethi / ; Ray Hershberger / ; Deirdre Nauman / ; Steven J Keteyian / ; Matthew Saval / ; Dalane W Kitzman / ; Brittney L Fray / ; Brian Moore / ; Ileana L Piña / ; Marianne Vest / ; Andrew Smith / ; Gail Snell / ; Eugene Wolfel / ; Mona Cantu / ; Kirkwood Adams / ; Jana Glotzer / ; Valerie Johnson / ; Kate Schumacher / ; Gordon Blackburn / ; Carrie Geither / ; Susan Moore / ; A Bleakley Chandler / ; Shanda Browning Vaughn / ; Paula J Easler / ; Debbie Williams / ; Julius M Gardin / ; Kelly Dimick / ; Sharon K Sklar / ; Sherri Teller / ; Jalal K Ghali / ; Karen Hale-Stenson / ; Mihai Gheorghiade / ; Theresa Strzelczyk / ; Maryl R Johnson / ; Cassondra Vander Ark / ; Lee R Goldberg / ; Andrew Kao / ; Jennifer Dekerlegand / ; William E Kraus / ; Johanna Johnson / ; Brian D Duscha / ; Mandeep R Mehra / ; Hector Ventura / ; Bobbett Harris / ; Monica Colvin-Adams / ; Kathy Duderstadt / ; Karen Meyer / ; Melissa Steger / ; Barry Cabuay / ; Ron M Oren / ; Page Scovel / ; Andrew Kao / ; Tracey Stevens / ; Karen Haffey / ; Christy Mandacina / ; Ann Stewart / ; Ann M Swank / ; John Manire / ; Paul D Thompson / ; Ludmila Cosio-Lima / ; Marie Lagasse / ; Tehmina Naz / ; Lynne Wagoner / ; Susan K Roll / ; Frank G Yanowitz / ; Johnny Walker / ; Adam Mueller / ; Peter McCullough / ; Cathy Coleman / ; Kimberly A Dorrell / ; Tamika Washington / ; Eileen Handberg / ; James A Hill / ; Jacqueline Bakos / ; Alice Boyette / ; Pamela Smith / ; Cynthia Williams / ; Dalynn Badenhop / ; Susan Schroeder / ; Kelly Walter / ; Peter Kokkinos / ; Elisse Collins / ; Lauren Korsak / ; Eric Eichhorn / ; Allison Leonard / ; Tina Worley / ; Gerald Fletcher / ; Phil Peasley / ; Pam Oldano / ; John Kostis / ; Nora M Cosgrove / ; Udho Thadani / ; Lisa Rogan / ; Michelle Thresher / ; John Turner / ; Denise Barnard / ; Denise Herman / ; Annette Contasti / ; Marcy Sagerian / ; Elizabeth Ofili / ; Anekwe Onwuanyi / ; Sunday Nkemdiche / ; Howard Eisen / ; James Fitzpatrick / ; Joyce Wald / ; Jennie Wong / ; Myrvin Ellestad / ; Leslie Kern / ; Ezra A Amsterdam / ; Mary J Burns / ; Savitri Fedson / ; Ravi K Garg / ; Peggy Bennett / ; Linda Bond / ; Leway Chen / ; Janice Schrack / ; Douglas Pearce / ; Linda Bond / ; Greg Palevo / ; Margarett Serfass / ; Daniel Forman / ; Maria M Lopez / ; Yemi Talabi-Oates / ; April Williams / ; David Truitte / ; Cindy Baumann / ; Jenny Adams / ; Anne Lawrence / ; Dennis McNamara / ; Emily Gruendler / ; Virginia Schneider / ; Steven Hutchins / ; Alyce Hartwick / ; Paul Campbell / ; Michele Esposito / ; Carol Buchter / ; Rebecca A Letterer / ; Robert Taylor / ; Cheri Wells / ; Bruce Johnson / ; Beth Kaping / ; Susan Leathes / ; Joseph O'Bryan / ; Lynn Langley / ; Edward T Hastings / ; Cassandra Clancy / ; Neil Agruss / ; Christine Lawless / ; Robin Fortman / ; Timothy R McConnell / ; Deb Wantz / ; Mary N Walsh / ; Regina Margiotti / ; Stuart Russell / ; Elizabeth Heck / ; Justine Lachmann / ; Diane Lippman / ; Jeannette McLaughlin / ; Joel Landzberg / ; Susan Mathus / ; David W Cullinane / ; Wyatt Voyles / ; Dione Lenz / ; Scott Kaczkowski / ; Jack L David / ; Eve Gillespie / ; Pat Keane-Richmond / ; Steven K Krueger / ; Lori Heiss / ; Stephen Gottlieb / ; Nancy Greenberg / ; Neil Gordon / ; Emily Parks / ; Melanie Willoughby / ; Marvin W Kronenberg / ; Jennie Glenn / ; Carol Madison / ; Malcolm Arnold / ; Julie K Smith / ; Eduardo Azevedo / ; Glen Drobot / ; Estrellita Estrella-Holder / ; Jonathan Howlett / ; Darlene Cooley-Warnell / ; Sheila Yarn / ; Debra Isaac / ; Jane Grant / ; Kim Lyzun / ; Marie-Helene LeBlanc / ; Rachel Vienneau / ; Robert S McKelvie / ; Linda Beare / ; Jill Hancock / ; Gordon Moe / ; Delores Golob / ; Kenneth Melvin / ; Anne Cymet / ; Judith Renton / ; Anil Nigam / ; Julie LaLonge / ; Karim Djaballah / ; Patrick Aebehard / ; Marie Christine Iliou / ; Remi Sabatier / ; Annette Belin / ; Alain Cohen-Solal / ; Luc Hittinger / ; Bertram Pitt / ; Philip A Ades / ; Lotfy L Basta / ; Victor Froelicher / ; Mary Elizabeth Hamel / ; Barry M Massie / ; Lemuel Moyé / ; Lynda H Powell / ; William E Kraus / ; Johanna Johnson / ; Lucy Piner / ; Daniel Bensimhon / ; Stuart Russell / ; Julius M Gardin / ; Renee L Bess / ; Gerald I Cohen / ; Steven J Keteyian / ; Jonathan K Ehrman / ; Clinton A Brawner / ; Nancy Houston Miller / ; James A Blumenthal / ; Krista Barbour / ; Tanya M Spruill / ; Bess Marcus / ; Jim Raczynski / ; Kirkwood Adams / ; Mark Donahue / ; Mike Felker / ; Kevin A Schulman / ; Kevin P Weinfurt / ; Kathryn E Flynn / ; Shelby Reed / ; Ann Burnette / ; Linda Davidson-Ray / ; Joëlle Y Friedman / ; Yanhong Li / ; Li Lin / ; Betsy O'Neal / ; Michael Zile / ; Ralph H Johnson / ; Daniel R Bensimhon / ; Vera Bittner / ; Robin Boineau / ; Mark E Dunlap / ; William E Kraus / ; Christopher M O'Connor / ; Gordon Moe / ; John Wertheimer / ; David J Whellan / |
| Comments/Corrections | |
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