Addition of Supervised Exercise Training to a Post-Hospital Disease Management Program for Patients Recently Hospitalized With Acute Heart Failure: The EJECTION-HF Randomized Phase 4 Trial.

OBJECTIVES: This study sought to measure the impact on all-cause death or readmission of adding center-based exercise training (ET) to disease management programs for patients with a recent acute heart failure (HF) hospitalization. BACKGROUND: ET is recommended for patients with HF, but evidence is based mainly on ET as a single intervention in stable outpatients. METHODS: A randomized, controlled trial with blinded outcome assessor, enrolling adult participants with HF discharged from 5 hospitals in Queensland, Australia. All participants received HF-disease management program plus supported home exercise program; intervention participants were offered 24 weeks of supervised center-based ET. Primary outcome was all-cause 12-month death or readmission. Pre-planned subgroups included age (<70 years vs. older), sex, left ventricular ejection fraction (≤40% vs. >40%), and exercise adherence. RESULTS: Between May 2008 and July 2013, 278 participants (140 intervention, 138 control) were enrolled: 98 (35.3%) age ≥70 years, 71 (25.5%) females, and 62 (23.3%) with a left ventricular ejection fraction of >40%. There were no adverse events associated with ET. There was no difference in primary outcome between groups (84 of 140 [60.0%] intervention vs. 90 of 138 [65.2%] control; p = 0.37), but a trend toward greater benefit in participants age <70 years (OR: 0.56 [95% CI: 0.30 to 1.02] vs. OR: 1.56 [95% CI: 0.67 to 3.64]; p for interaction = 0.05). Participants who exercised to guidelines (72 of 101 control and 92 of 117 intervention at 3 months) had a significantly lower rate of death and readmission (91 of 164 [55.5%] vs. 41 of 54 [75.9%]; p = 0.008). CONCLUSIONS: Supervised center-based ET was a safe, feasible addition to disease management programs with supported home exercise in patients recently hospitalized with acute HF, but did not reduce combined end-point of death or readmission. (A supervised exercise programme following hospitalisation for heart failure: does it add to disease management?; ACTRN12608000263392).

Exercise training in recently hospitalized heart failure patients enrolled in a disease management programme: design of the EJECTION-HF randomized controlled trial.

AIMS: The Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) study will evaluate the impact of a supervised exercise training programme (ETP) on clinical outcomes in recently hospitalized heart failure patients attending a disease management programme (DMP). Methods This multisite, pragmatic randomized controlled trial enrols patients discharged from participating hospitals with clinical evidence of heart failure who are willing and able to participate in a DMP and considered clinically safe to exercise. Enrolment includes participants with impaired and preserved left ventricular systolic function. Baseline assessment and programme commencement occur within 6 weeks of hospital discharge. The control group DMP includes individualized education and follow-up from a multidisciplinary heart failure team; a weekly education programme for 12 weeks; self-management advice; and medical follow-up. Home exercise is recommended for all participants. In addition, intervention participants are offered 36 supervised, structured gym-based 1 h exercise sessions over 24 weeks. Sessions are tailored to exercise capacity and include aerobic, resistance, and balance exercises. Enrolment target is 350 participants. Primary outcome is 12-month mortality and readmissions. Secondary outcomes include blinded evaluation of depressive symptoms, sleep quality, cognition, and functional status (activities of daily living, 6 min walk distance, grip strength) at 3 and 6 months. A cost-utility analysis will be conducted. CONCLUSION: This study will enrol a representative group of hospitalized heart failure patients and measure a range of patient and health service outcomes to inform the design of post-hospital DMPs for heart failure. Enrolment will be completed in 2013. ACTRN12608000263392.