See comment in PubMed Commons belowJAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457.
Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial.
Flynn KE1,
Piña 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;
HF-ACTION Investigators.
O'Connor CM, Lee KL, Ellis SJ, Rendall DS, Whellan DJ, Piña IL, Keteyian SJ, Cooper LS, Boineau R, Fine LJ, Fleg JL, Leifer ES, Erickson V, Howlett JG, Miller NH, Isaac D, McKelvie R, Zannad F, Boozer S, Connolly P, Doll A, Ellis SJ, Frazier C, Mark D, McClanahan-Crowder M, Meyer M, Mickley BS, Rendall DS, Rich M, Rostami H, Settles S, Spinella K, Staib J, Thompson O, Abraham W, Biniakiewicz D, Homan J, Bittner V, Fitz-Gerald M, Ewald G, Craddock H, Flanagan J, Fonarow G, Erickson V, Colucci W, Lim NZ, Tokareva E, Alharethi R, Hershberger R, Nauman D, Keteyian SJ, Saval M, Kitzman DW, Fray BL, Moore B, Piña IL, Vest M, Smith A, Snell G, Wolfel E, Cantu M, Adams K, Glotzer J, Johnson V, Schumacher K, Blackburn G, Geither C, Moore S, Chandler AB Jr, Vaughn SB, Easler PJ, Williams D, Gardin JM, Dimick K, Sklar SK, Teller S, Ghali JK, Hale-Stenson K, Gheorghiade M, Strzelczyk T, Johnson MR, Ark CV, Goldberg LR, Kao A, Dekerlegand J, Kraus WE, Johnson J, Duscha BD, Mehra MR, Ventura H, Harris B, Colvin-Adams M, Duderstadt K, Meyer K, Steger M, Cabuay B, Oren RM, Scovel P, Kao A, Stevens T, Haffey K, Mandacina C, Stewart A, Swank AM, Manire J, Thompson PD, Cosio-Lima L, Lagasse M, Naz T, Wagoner L, Roll SK, Yanowitz FG, Walker J, Mueller A, McCullough P, Coleman C, Dorrell KA, Washington T, Handberg E, Hill JA, Bakos J, Boyette A, Smith P, Williams C, Badenhop D, Schroeder S, Walter K, Kokkinos P, Collins E, Korsak L, Eichhorn E, Leonard A, Worley T, Fletcher G, Peasley P, Oldano P, Kostis J, Cosgrove NM, Thadani U, Rogan L, Thresher M, Turner J, Barnard D, Herman D, Contasti A, Sagerian M, Ofili E, Onwuanyi A, Nkemdiche S, Eisen H, Fitzpatrick J, Wald J, Wong J, Ellestad M, Kern L, Amsterdam EA, Burns MJ, Fedson S, Garg RK, Bennett P, Bond L, Chen L, Schrack J, Pearce D, Bond L, Palevo G, Serfass M, Forman D, Lopez MM, Talabi-Oates Y, Williams A, Truitte D, Baumann C, Adams J, Lawrence A, McNamara D, Gruendler E, Schneider V, Hutchins S, Hartwick A, Campbell P, Esposito M, Buchter C, Letterer RA, Taylor R, Wells C, Johnson B, Kaping B, Leathes S, O'Bryan J, Langley L, Hastings ET, Clancy C, Agruss N, Lawless C, Fortman R, McConnell TR, Wantz D, Walsh MN, Margiotti R, Russell S, Heck E, Lachmann J, Lippman D, McLaughlin J, Landzberg J, Mathus S, Cullinane DW, Voyles W, Lenz D, Kaczkowski S, Gillespie E, Keane-Richmond P, Krueger SK, Heiss L, Gottlieb S, Greenberg N, Gordon N, Parks E, Willoughby M, Kronenberg MW, Glenn J, Madison C, Arnold M, Smith JK, Azevedo E, Drobot G, Estrella-Holder E, Howlett J, Cooley-Warnell D, Yarn S, Isaac D, Grant J, Lyzun K, LeBlanc MH, Vienneau R, McKelvie RS, Beare L, Hancock J, Moe G, Golob D, Melvin K, Cymet A, Renton J, Nigam A, LaLonge J, Djaballah K, Aebehard P, Iliou MC, Sabatier R, Belin A, Cohen-Solal A, Hittinger L, Pitt B, Ades PA, Basta LL, Froelicher V, Hamel ME, Massie BM, Moyé L, Powell LH, Kraus WE, Johnson J, Piner L, Bensimhon D, Russell S, Gardin JM, Bess RL, Cohen GI, Keteyian SJ, Ehrman JK, Brawner CA, Miller NH, Blumenthal JA, Barbour K, Spruill TM, Marcus B, Raczynski J, Adams K, Donahue M, Felker M, Schulman KA, Weinfurt KP, Flynn KE, Reed S, Burnette A, Davidson-Ray L, Friedman JY, Li Y, Lin L, O'Neal B, Zile M, Johnson RH, Bensimhon DR, Bitner V, Boineau R, Dunlap ME, Kraus WE, O'Connor CM, Moe G, Wertheimer J, Whellan DJ.
- 1
- Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27715, USA. kathryn.flynn@duke.edu
Abstract
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 2331 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 = 1172), consisting of 36 supervised sessions followed by home-based training, vs usual care alone (n = 1159). 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 < .001). After 3 months, there were no further significant changes in KCCQ score for either group (P = .85 for the difference between slopes), resulting in a sustained, greater improvement overall for the exercise group (P < .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.
Figure 1
Flow of Participants Through the Trial
JAMA. ;301(14):1451-1459.
Figure 2
Predicted Average Health Status Trajectories by Treatment Group Note: P = .001 for treatment effect for both ischemic and nonischemic heart failure. Error bars indicate SEs at each time point.
JAMA. ;301(14):1451-1459.
Figure 3
Distribution of Predicted Change From Baseline to 3 Months in the KCCQ Overall Summary Score by Treatment Group Note: Bin size = 2. The bin centered over zero ranges from greater than −1 to 1.
JAMA. ;301(14):1451-1459.
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