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

2011; Elsevier BV; Volume: 13; Issue: 12 Linguagem: Inglês

10.1093/eurjhf/hfr139

1879-0844

Alison Mudge, Charles Denaro, Adam Scott, J. Atherton, Deborah E. Meyers, Thomas H. Marwick, Julie Adsett, Robert Mullins, Jessica Suna, Paul Scuffham, Peter O’Rourke,

Cardiac Health and Mental Health

European Journal of Heart FailureVolume 13, Issue 12 p. 1370-1375 Study DesignFree Access Exercise training in recently hospitalized heart failure patients enrolled in a disease management programme: design of the EJECTION-HF randomized controlled trial Alison M. Mudge, Corresponding Author Alison M. Mudge University of Queensland School of Medicine, Brisbane, AustraliaCorresponding author. Tel: +61 7 36360854, Fax: +61 7 36360272, Email: [email protected]Search for more papers by this authorCharles P. Denaro, Charles P. Denaro University of Queensland School of Medicine, Brisbane, AustraliaSearch for more papers by this authorAdam C. Scott, Adam C. Scott Queensland University of Technology School of Public Health, Brisbane, AustraliaSearch for more papers by this authorJohn J. Atherton, John J. Atherton Cardiology Department, Royal Brisbane and Women's Hospital, Brisbane, AustraliaSearch for more papers by this authorDeborah E. Meyers, Deborah E. Meyers University of Texas Medical School, Houston, TX, USASearch for more papers by this authorThomas H. Marwick, Thomas H. Marwick Cardiovascular Imaging, Heart and Vascular Unit, Cleveland Clinic, Cleveland, OH, USASearch for more papers by this authorJulie A. Adsett, Julie A. Adsett Heart Failure Service, Royal Brisbane and Women's Hospital, Brisbane, AustraliaSearch for more papers by this authorRobert W. Mullins, Robert W. Mullins Heart Failure Service, Royal Brisbane and Women's Hospital, Brisbane, AustraliaSearch for more papers by this authorJessica M. Suna, Jessica M. Suna Queensland University of Technology School of Public Health, Brisbane, AustraliaSearch for more papers by this authorPaul A. Scuffham, Paul A. Scuffham Griffith University School of Medicine, Brisbane, AustraliaSearch for more papers by this authorPeter K. O'Rourke, Peter K. O'Rourke Queensland Institute of Medical Research, AustraliaSearch for more papers by this author Alison M. Mudge, Corresponding Author Alison M. Mudge University of Queensland School of Medicine, Brisbane, AustraliaCorresponding author. Tel: +61 7 36360854, Fax: +61 7 36360272, Email: [email protected]Search for more papers by this authorCharles P. Denaro, Charles P. Denaro University of Queensland School of Medicine, Brisbane, AustraliaSearch for more papers by this authorAdam C. Scott, Adam C. Scott Queensland University of Technology School of Public Health, Brisbane, AustraliaSearch for more papers by this authorJohn J. Atherton, John J. Atherton Cardiology Department, Royal Brisbane and Women's Hospital, Brisbane, AustraliaSearch for more papers by this authorDeborah E. Meyers, Deborah E. Meyers University of Texas Medical School, Houston, TX, USASearch for more papers by this authorThomas H. Marwick, Thomas H. Marwick Cardiovascular Imaging, Heart and Vascular Unit, Cleveland Clinic, Cleveland, OH, USASearch for more papers by this authorJulie A. Adsett, Julie A. Adsett Heart Failure Service, Royal Brisbane and Women's Hospital, Brisbane, AustraliaSearch for more papers by this authorRobert W. Mullins, Robert W. Mullins Heart Failure Service, Royal Brisbane and Women's Hospital, Brisbane, AustraliaSearch for more papers by this authorJessica M. Suna, Jessica M. Suna Queensland University of Technology School of Public Health, Brisbane, AustraliaSearch for more papers by this authorPaul A. Scuffham, Paul A. Scuffham Griffith University School of Medicine, Brisbane, AustraliaSearch for more papers by this authorPeter K. O'Rourke, Peter K. O'Rourke Queensland Institute of Medical Research, AustraliaSearch for more papers by this author First published: 18 February 2014 https://doi.org/10.1093/eurjhf/hfr139Citations: 19AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Abstract 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. Trial registration: ACTRN12608000263392 Introduction Congestive heart failure is a common and generally progressive condition which is estimated to affect 300 000 Australians. In 2007–08, heart failure was the principal diagnosis for 45 000 Australian hospital admissions and an additional diagnosis in 95 000 more.1 The prevalence rises with age, affecting 10% of people aged 70 years or older. The clinical syndrome of heart failure is characterized by fatigue, breathlessness, and exercise intolerance, and has a profound effect on quality of life, often accompanied by social and functional limitations, depressive symptoms, and sleep and appetite disturbance.2–5 Advances in pharmacological therapies (including angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, and aldosterone antagonists) and devices (implantable cardioverter defibrillators and biventricular pacing) have been shown in clinical trials to improve physiological parameters and quality of life, reduce symptoms, and decrease mortality and readmission rates. However, the overall impact on outcomes has been modest in epidemiological studies.6–8 Heart failure remains the most common cause of hospitalization in the elderly, and accounts for a substantial personal and economic burden as well as significant mortality.1,9,10 This challenge has led to the development of organized heart failure disease management programmes (DMPs) which include education, self-management training, symptom monitoring, and outreach by a multidisciplinary team of specially trained nurses and other health professionals. There is strong evidence that such DMPs can improve outcomes including mortality and hospital readmissions in patients recently discharged from hospital with heart failure.11–14 Exercise training has been investigated as an additional management strategy in heart failure outpatients on stable medical therapy. Studies have demonstrated that exercise training is safe, can improve exercise capacity and quality of life for outpatients with heart failure, and may reduce heart failure-related readmissions.15–17 However, exercise training has largely been investigated as a single intervention, delivered in stable patients without a recent hospitalization. While trials have compared a post-discharge DMP which includes structured exercise training with usual clinical follow-up,18,19 there have been no trials comparing a DMP with and without exercise training in the early post-hospital period. This is an important clinical question for the design of heart failure services, because the addition of a centre-based exercise programme adds considerably to staffing and equipment costs. However, participants with a recent hospitalization may be particularly motivated to engage in an exercise training programme, and the high rate of adverse outcomes in recently discharged heart failure patients (compared with stable outpatients) may result in greater absolute benefits in this population. Several other questions remain regarding exercise training. While it is now recognized that up to one half of clinical heart failure patients have preserved left ventricular ejection fraction on echocardiography,20 most clinical trials have only included patients with proven systolic dysfunction.15 Women and elderly patients remain under-represented in trial populations. Finally, the outcome measures used in most studies have been limited to exercise capacity, quality of life, and service use, despite the adverse effect of this condition on a wide range of patient experiences. This study aims to assess the value of a structured exercise training programme (ETP), in addition to a DMP for heart failure, in a representative sample of adult patients with a recent hospitalization for heart failure who are able to undertake a DMP and are considered clinically safe to exercise. The primary hypothesis is that DMP + ETP compared with DMP alone can reduce the rate of death and readmission at 12 months. Secondary hypotheses are that, compared with DMP alone, DMP +ETP can: reduce depressive symptoms at 3 and 6 months improve functional status at 3 and 6 months improve cognitive status at 3 and 6 months improve sleep quality at 3 and 6 months improve quality of life at 6 months. We also hypothesize that DMP + ETP may be cost-effective from the perspective of the healthcare system compared with DMP alone, due to the reduction in readmission rates offsetting the additional costs of the ETP. Methods Study design The study is a multisite randomized controlled trial with blinded outcome assessment. The study conforms with the Declaration of Helsinki and has been approved by the Human Research Ethics Committees of participating hospitals, and is included in the Australian Clinical Trials Registry (ACTR12608000263392). Study subjects and recruitment The study recruits adult patients discharged from participating hospitals with heart failure as a dominant clinical diagnosis. Study hospitals include three tertiary metropolitan teaching hospitals [Royal Brisbane and Women's (RBWH), Princess Alexandra, and The Prince Charles (TPCH)] and two regional hospitals (Logan and Ipswich), all located in south-east Queensland, Australia. These hospitals were selected because they had an established DMP, and had implemented or were planning to implement an ETP. Inpatients are actively identified by heart failure service staff using daily bed lists and direct referrals, and potential participants are referred to the research nurse. Patients are eligible if they have documented evidence of symptoms (dyspnoea, fatigue and/or peripheral oedema) and signs (raised jugular venous pressure, displaced apex beat, third heart sound, and/or crepitations on chest auscultation) of heart failure during their hospital admission, are discharged on medical therapy for heart failure, and have chest X-ray or recent (within 6 months) echocardiographic findings consistent with heart failure. Participants must be able to complete baseline assessment and commence the assigned treatment within 6 weeks of hospital discharge. Patients are ineligible if they are unsuitable for the intervention because they are terminally ill, live outside the hospital catchment area, or have severe cognitive, language, psychological, or physical disabilities which would preclude participation in the programme. Patients are also ineligible if they are waiting for a cardiovascular procedure including revascularization or insertion of an implantable cardioverter defibrillator or cardiac resynchronization therapy, or if they have already completed a 12 week structured exercise programme within the previous 12 months. Patients are excluded if they are considered unsafe for exercise according to safety criteria adapted from the American College of Sports Medicine (see Box ).21 Eligible participants are provided with written and verbal information about the study during their inpatient stay or in the early post-hospital period, and are invited to participate in the trial. The research nurse obtains written informed consent from all participants and undertakes a baseline assessment within 6 weeks of hospital discharge. The research nurse informs the trial co-ordinator of each enrolment. Patients who choose not to participate in the trial are offered standard care including the DMP (control conditions). Box 1 Clinical safety criteria Patients are considered unsuitable for randomization if they have: refractory chest pain poorly controlled arrhythmias causing haemodynamic symptoms high degree AV block pacemakers which do not permit adequate heart rate response to exercise significant uncorrected primary valvular disease isolated pulmonary hypertension poorly controlled symptomatic postural hypotension obstructive cardiomyopathies Randomization Consenting participants are randomized to DMP or to DMP + ETP by the trial statistician using computer-generated sequences in blocks of 10, stratified by study site. Sequential, sealed opaque envelopes containing the assigned group are provided to the trial co-ordinator, who arranges participant attendances and appointments. Study conditions (Figure 1) Figure 1. Study schema for the EJECTION trialOpen in figure viewerPowerPoint Control Participants randomized to the control group receive a heart failure DMP delivered by a specialist multidisciplinary heart failure outreach team at each hospital. The organization and processes at each site vary depending on local governance and resourcing models, although there is a state-wide heart failure service co-ordinator and processes exist for information sharing between services. Participants are provided with one-on-one education by a specialist heart failure nurse, and invited to attend a 12 week programme of weekly 1 h education sessions which include the pathophysiology of heart failure, pharmacotherapy, dietary and fluid management, self-management principles, and sleep and anxiety management. One session is specifically devoted to the role of exercise, and all participants are provided with a home exercise programme which is reviewed regularly by DMP staff. The home exercise programme aims to progress participants to the National Physical Activity Guidelines and is prescribed based on the Exercise and Sports Science Australia Position Statement on exercise training and chronic heart failure.22 Information is provided regarding exercise safety and an action plan for adverse signs and symptoms (e.g. chest pain, breathlessness, or pre-syncope). Participants receive home visits and/or telephone follow-up by nursing and pharmacy staff according to clinical need, available resources, and personal preferences for up to 6 months following hospital discharge. Medical review is scheduled by the attending medical team, and may include specialist cardiology, specialist physician, or general practitioner (GP) follow-up. A structured discharge summary, which may include information about medication titration, is provided to the GP at the time of hospital discharge, and further changes are communicated to the GP by the heart failure service during the follow-up period. Intervention In addition to the DMP described above, participants randomized to the intervention are offered 36 sessions of a structured gymnasium-based exercise class over 24 weeks (twice per week for 12 weeks followed by once per week for 12 weeks). Exercise classes are jointly supervised by a nurse and a physiotherapist or exercise physiologist, and consist of 10 min of warm up, 45–50 min of exercise, and 10 min cool down. Exercise incorporates upper limb and lower limb aerobic and resistance training.23–25 The exercise programme is individually prescribed following performance of a submaximal exercise test (6 min walk test) and with consideration of physical limitations imposed by co-morbid conditions. Aerobic exercise is prescribed in an interval training format, with exercise intensity initiated and progressed according to the rating of perceived exertion (RPE; Borg scale 9–13) and a work:rest ratio of 1:1 progressed to 2:1. Resistance training is commenced at 6–15 repetitions and progressed to three sets, maintaining an RPE of 9–13. In frail individuals, initial goals may be more modest and a greater period of rest provided. Flexibility exercises are incorporated into the cool down, and balance-specific activities are included for those in whom a deficit is identified. Intervention participants are provided with an individual home-based exercise programme, which they are encouraged to complete in addition to exercise classes to accumulate five planned exercise sessions per week. The prescription is a mix of aerobic and resistance exercise using minimal equipment. It is supported by an information book and diary for recording exercise, by motivational interviewing techniques by the exercise professionals involved in the programme, and by reinforcement of techniques and adherence at the gym-based sessions. Outcome measures The primary outcome is the proportion of patients who have died or been readmitted for any cause within 12 months of enrolment. Hospital readmissions are defined as any admitted episode to a Queensland public hospital, and dates of all readmissions will be obtained from the Queensland Health Admitted Patients Data Collection by probabilistic matching. Date of death will be obtained by the Queensland Health Statistics Centre from the state-wide death registry. Dates of death and readmission will be verified where possible by hospital records. Secondary clinical outcomes are collected 3 and 6 months after programme commencement using a standardized assessment, by a research nurse unaware of treatment assignment. These outcomes are: Depressive symptoms measured using the Geriatric Depression Scale (a validated measure of depressive symptoms in older adults) and the Hare–Davis Cardiac Depression Scale (a validated measure of depressive symptoms in patients with a range of cardiac disorders).26,27 Functional status measured using a standardized 6 min walk test as a measure of submaximal exercise capacity, hand-held dynamometry as a measure of grip strength, and activities of daily living using standardized questions. Cognitive status using Folstein's mini-mental status examination.28 Quality of life using the Assessment of Quality of Life (AQoL) instrument, a utility instrument validated in Australian clinical and non-clinical population samples which will permit determination of health utilities allowing a cost–utility analysis.29 Sleep quality using the Pittsburgh Sleep Quality Index30 in a subset of patients. Healthcare use including hospital admissions and outpatient and emergency department attendances obtained from the hospital information systems. Confounding variables Baseline variables obtained from the medical record and baseline assessment include age, sex, aetiology of heart failure, systolic dysfunction, atrial fibrillation, de novo vs. decompensated heart failure, New York Heart Association (NYHA) class, co-morbidities, use of evidence-based medications and implantable devices, baseline functional status, baseline depressive symptoms, and recruiting hospital. Process measures Attendance at education and exercise sessions is recorded by programme staff for each participant. Home visits, telephone follow-up, and other DMP activities are recorded for each participant. Self-reported home exercise is recorded at 3 and 6 month follow-up, aided by completion of a home exercise diary. Analysis Analysis will be undertaken on an intention-to-treat basis. Baseline characteristics will be summarized and compared between the control and intervention group using standard summary statistics. Differences in the proportion of patients with the primary outcome will be evaluated using contingency tables and χ2 testing. Time to event analysis will be undertaken using Kaplan–Meier curves and the log rank test. If there are significant difference between the groups in baseline confounding variables, logistic and Cox regression analysis will be undertaken adjusting for these differences. Differences between groups in secondary outcomes will be tested using χ2 testing testing for categorical variables or Student's t-test (or appropriate non-parametric testing if indicated) for continuous variables. Significance will be taken as P < 0.05 in all analyses. Planned subgroup analyses will explore the impact of the intervention in females, participants aged >70 years, and participants with preserved systolic function, as these groups have been under-represented in previous research. Economic analysis will be undertaken from the perspective of the healthcare system, using cost–utility methods. Costs will be modelled based on additional measured or estimated capital set-up costs for the exercise programme adjusted for inflation, and estimated additional staffing requirements at current prices. Health resource utilization costs will be calculated from bed-day use, outpatient attendances, and emergency department attendances, and health utilities determined by comparing AQoL scores. Sample size Estimating a control group event rate (12 month death or readmission) of 40–60% and assuming a 15% absolute reduction, with an α of 0.05 (two-sided) and power of 80%, we will require a sample size of 173 participants per group or a total enrolment of 346. The primary outcome will be available for all participants as it is obtained from third-party sources, but we anticipate a drop-out rate for secondary clinical outcomes of 20–30% by 6 months. Study integrity Due to the nature of the intervention, participants and programme staff delivering the intervention cannot be blinded to allocation. However, the research officers conducting the baseline, 3 and 6 month assessments are unaware of group assignment, and death and readmission data will be obtained from third party data sources. Discussion The study has recruited 150 participants so far (mean age 62 years, 27% female, 30% left ventricular ejection fraction >40%). Eligibility at the initial tertiary sites (RBWH and TPCH) was lower than anticipated due to a high proportion of out-of-area patients, and some patients re-presenting with exacerbations were ineligible because of previous ETP participation, as both sites had an established exercise programme before the trial commenced. Consent rates have also been lower than anticipated (∼30%), reflecting the time demands of this complex intervention in an older, chronically unwell patient group. Slow recruitment will be mitigated by the addition of two regional hospitals (Logan and Ipswich) and a further tertiary referral site (Princess Alexandra Hospital). The range of sites is an important strength of the study in terms of generalizability of findings. Patient characteristic vary between sites, reflecting local socio-demographic factors and the extent of external referral. Each site has been requested to structure their education and exercise programmes to offer a 12 week programme with 'rolling' entry to facilitate commencement within 6 weeks of discharge, and ETP protocols have been provided. The study has also facilitated sharing of some resources such as education materials between services. However, other features of the programme, such as staffing levels, mix of home and clinic visits offered, extent of telephone follow-up, patient education materials, and type of medical follow-up, are at the discretion of the individual services, and will contribute to the detailed process evaluation to describe and understand variability between services. Randomization has been stratified by site to minimize confounding by these structural features. We recognize the risk that the effect size of our intervention may be limited because we are only offering twice-weekly exercise, which is less intensive than some previous studies. This reflects the pragmatic nature of our trial. This choice was informed by staff and participants in our existing heart failure ETPs, who believed that attendance at a more intensive programme would be poor. We are also aware of the risk of contamination as we are providing home exercise advice to the control group. However, in light of current guidelines,31 we did not consider it ethical to do otherwise. Finally, we recognize that only a minority of heart failure patients will meet eligibility and consent requirements for this relatively demanding 24 week research programme, which may limit its generalizability. We are currently enrolling ∼12% of all inpatients screened by the service, which is comparable with rates reported in other studies of ETP and/or DMP in heart failure.32–34 Despite these potential weaknesses, this study will provide practical evidence for post-hospital disease management programmes in heart failure regarding the clinical effectiveness and cost-effectiveness of a formal centre-based exercise rehabilitation programme in the early weeks after a hospitalization with heart failure, which has been missing to date.35 Process measures will quantify adherence to the proposed intervention, which has been missing in many previous trials, as well as allowing us to quantify diversity between different real-world DMPs. Exercise adherence remains a significant challenge; this trial will provide meaningful information to patients and carers regarding the potential and immediate benefits of exercise by addressing a wider range of important patient-centred outcomes including depressive symptoms, dependency in everyday functional tasks, and sleep quality. Funding The Australian National Health and Medical Research Council (NHMRC Project Grant no. 498403); the Royal Brisbane and Women's Hospital Foundation; The Prince Charles Hospital Foundation. The funding bodies have no input into study design, data management or analysis, or the decision to publish. Conflict of interest: none declared. Authors' contributions: A.M. conceived and designed the study and drafted the manuscript. C.D., A.S., J.J.A., D.E.M. and T.M. contributed to design of the intervention and evaluation. J.A.A. and R.M. designed the exercise protocols and contributed to study design. J.S. contributed to design of methods and study flow. P.O. and P.S. contributed to design of the statistical and economic evaluations. All authors reviewed and approved the manuscript. Acknowledgments The authors thank Diane Bookless, Dr George Javorsky, Dr Jeffrey Franco, Dr Johannes Moolman, Dr Darius Korczyk, Annabel Hickey, and the staff and patients of the heart failure services at participating hospitals. References 1 Australian Institute of Health and Welfare Cardiovascular Disease: Australian Facts 2011. Cardiovascular Disease Series 2011Canberra AIHW 2KonstamV, MoserDK, deJongMJ. Depression and anxiety in heart failure J Card Fail 2005 11 455– 463 3VogelsRL, ScheltensP, Schroeder-TankaJM, WeinsteinHC. Cognitive impairment in heart failure: a systematic review of the literature Eur J Heart Fail 2007 9 440– 449 4SandekA, DoehnerW, AnkerSD, vonHaelingS. Nutrition in heart failure: an update Curr Opin Clin Nutr Metab Care 2009 12 384– 391 5RaoA, GrayD. 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A consensus document of the Heart Failure Association and the European Association for Cardiovascular Prevention and Rehabilitation Eur J H Fail 2011 13 347– 357 Citing Literature Volume13, Issue12December 2011Pages 1370-1375 FiguresReferencesRelatedInformation