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Home-based cardiac rehabilitation improves quality of life, aerobic capacity, and readmission rates in patients with chronic heart failure

Home-based cardiac rehabilitation improves quality of life, aerobic capacity, and readmission... Background: Exercise tolerance and cardiac output have a major impact on the quality of life (QOL) of patients experiencing heart failure (HF). Home-based cardiac rehabilitation can significantly improve not only exercise tolerance but also peak oxygen uptake (VO peak), and the QOL in patients with HF. The aim of this prospective study was to evaluate the beneficial effects of home-based cardiac rehabilitation on the quality of medical care in patients with chronic HF. Methods: This study was a randomized prospective trial. HF patients with a left ventricular ejection fraction (LVEF) of less than 50% were included in this study. We randomly assigned patients to the control group (n=18) and the interventional group (n=19). Within the interventional group, we arranged individualized rehabilitation programs, including home-based cardiac rehabilitation, diet education, and management of daily activity over a 3-month period. Information such as general data, laboratory data, Cardiopulmonary Exercise Test (CPET) results, Six-minute Walk Test (6MWT) results, and the scores for the Minnesota Living with Heart Failure Questionnaire (MLHFQ) before and after the intervention, was collected from all patients in this study. Results: Patients enrolled in the home-based cardiac rehabilitation programs displayed statistically significant improvement in VO peak (18.2±4.1 vs 20.9±6.6mL/kg/min, P=.02), maximal 6-Minute Walking Distance (6MWD) (421±90 vs 462±74m, P=.03), anaerobic threshold (12.4±2.5 vs 13.4±2.6mL/kg/min, P=.005), and QOL. In summary, patients receiving home-based cardiac rehabilitation experienced a 14.2% increase in VO peak, a 37% increase in QOL score, and an improvement of 41m on the 6MWD test. The 90-day readmission rate for patients reduced to 5% from 14% after receiving cardiac rehabilitation. Conclusion: Home-based cardiac rehabilitation offered the most improved results in functional capacity, QOL, and a reduced the rate of readmission within 90 days. Abbreviations: 6MWD = six-minute walk distance, 6MWT = six-minute walk test, AHA = American Heart Association, AT = anaerobic threshold, CABG = coronary artery bypass grafting, CI = cardiac index, CO = cardiac output, CPET = cardiopulmonary exercise test, CRT = cardiac resynchronization therapy, EF = ejection fraction, HF = heart failure, HFrEF = heart failure with reduced ejection fraction, ICON = left ventricle contractility index, IRB = Institutional Review Board, LVEF = left ventricle ejection fraction, MET = metabolic equivalent, MLHFQ = Minnesota Living With HF Questionnaire, NYHA Fc = New York Heart Association Functional Classification, VO peak = peak oxygen uptake, QOL = quality of life, SV = stroke volume, SVR = systemic vascular resistance, TFI = thoracic fluid index. Keywords: heart failure, home-based cardiac rehabilitation, quality of medical care Editor: Yen-Hung Lin. Both YWC and CYW contributed equally to this article. The principal investigator, JLH, had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Funding/support: This study was supported in part by grants from the Taiwan National Science Council (NSC-100–2314-B-075A-005-MY3, 101–2314-B-758–002-, 102–2314-B-758–001-, 103–2314-B-758–001-), and grants from the Taichung Veterans General Hospital (TCVGH-1033106C, 1043106C, 1043102B, 1053106C, 1063106C). This study was registered at the US National Institutes of Health (ClinicalTrials.gov) # NCT02928783. The authors have no potential conflicts of interest. a b c Department of Physical Medicine and Rehabilitation, Cardiovascular Center, Taichung Veterans General Hospital, Department of Health Business Administration, Hung Kuang University, Taichung, Institute of Clinical Medicine, and Cardiovascular Research Institute, Department of Medicine, School of Medicine, National Yang- Ming University, Taipei, Department of Physical Medicine and Rehabilitation, School of Medicine, National Defense Medical Center, Taipei, Taiwan. Correspondence: Jin-Long Huang, Cardiovascular Center, Taichung Veterans General Hospital, 1650 Taiwan Boulevard Sect. 4, Taichung 40705, Taiwan (e-mail: golden@vghtc.gov.tw); Shin-Tsu Chang, Department of Physical Medicine and Rehabilitation, Taichung Veterans General Hospital, 1650 Taiwan Boulevard Sect. 4, Taichung 40705, Taiwan (e-mail: rehchang@vghtc.gov.tw). Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Medicine (2018) 97:4(e9629) Received: 2 May 2017 / Received in final form: 26 December 2017 / Accepted: 27 December 2017 http://dx.doi.org/10.1097/MD.0000000000009629 1 Chen et al. Medicine (2018) 97:4 Medicine 1. Introduction were scrambled before being made available to researchers in order to ensure that individual identifying information at any Heart failure (HF) is a common yet complicated disease resulting level could not be obtained from the database. Clinical data of from multiple etiologies, including coronary artery disease, patients in the study were collected by both nurses and case hypertension, and certain metabolic disorders, leading to over managers within the cardiology department. The study then [1] 10,000 deaths each year in Taiwan. HF is not curable and proceeded after obtaining permission from the hospital’s requires long-term evaluation and medical care. The incidence Institutional Review Board (IRB). and prevalence rates of HF are increasing annually due to an aging populations, along with an increase in the prevalence rate of chronic systemic disorders, including hypertension, type 2 2.2. Study subjects [2,3] diabetes mellitus, and hyperlipidemia. The average age of HF patients in either the ward or outpatient department with a patients with HF is also decreasing. The therapeutic goal of HF is left ventricle ejection fraction (LVEF) of less than 50% were to avoid any aggravating symptoms, improve health-related included in this study. We evaluated the functional stage of HF [1,4] quality of life (QOL), and decrease the costs of health care. using the New York Heart Association Functional Classification Although several reports have suggested that the mortality rate (NYHA Fc) guidelines. Patients experiencing NYHA Fc IV, of patients with HF is improving, the overall mortality rate still pregnancy, a high bedridden status, musculoskeletal system remains high. It has been estimated that more than 23% of problems, and disabilities for which exercise is contraindicated, [5] rehospitalizations for HF occur within 60 to 90 days, while less were excluded from this study. HF patients with a preserved [5– than 50% of patients with HF will survive for more than 5 years. ejection fraction (LVEF >50%) were excluded from this study 7] According to the registry data of the American Heart Association due to a difficulty with performing a dedicated evaluation. [7] (AHA) for Projections, the prevalence of HF will increase by 46% between 2012 and 2030, where patients with HF who are 2.3. Measurements younger than 65 years old will have a 6 to 9 times greater risk of experiencing sudden cardiac death when compared with that of the All patients had to sign a consent form before joining this study. [7] general population. The huge medical expense of HF leads to a We recorded each patient’s general data, including body height, heavy economic burden on both the patient’s family and the health body weight, and laboratory data during their admission and care system. Previous studies have shown that some symptoms of outpatient visits. We then evaluated each patients’ QOL using the HF, including fatigue and dyspnea on exertion, make the daily Minnesota Living With HF Questionnaire (MLHFQ) during the [3] activities of patients with HF intolerable. Additionally, the study period. We also monitored several parameters including aggravated symptoms of HF may cause depression, anxiety, and a VO peak, anaerobic threshold (AT) through use of the [8–10] compromised QOL for the patient. Cardiopulmonary Exercise Test (CPET) and the 6 Minutes Several studies have shown that cardiopulmonary rehabilita- Walking Test (6MWT) in order to evaluate the change exercise tion programs are both safe and effective for improving tolerance during the study period. According to the data obtained functional capacity and QOL, as well as for reducing the from both the CPET and 6MWT, we designed an individualized readmission rates and all-cause mortality of patients with home-based cardiac rehabailitation program according to each [1,11,12] HF. The results of many clinical trials have established patient’s willingness. In addition, we monitored the parameters of the benefits of hospital-based cardiac rehabilitation for patients their hemodynamics status, including stroke volume (SV), LVEF, [13–15] with HF. Home-based cardiac rehabilitation may be more and thoracic fluid index (TFI), by using a noninvasive cardiac accessible and acceptable when compared with hospital-based output monitor (Aesculon [Osypka Medical, Berlin, Germany]) cardiac rehabilitation. However, home-based rehabilitation during the study period. We measured the patients’ general data programs have not been widely studied and their training effects and physiologic parameters in both groups at the beginning of the [1,13,16] remain unclear. Thus, the purpose of this study was to study and also 3 months later. Finally, we compared all collected evaluate the effects of home-based cardiac rehabilitation on the data from both groups to evaluate both the change of exercise improvement in functional capacity, enhancement in QOL, and tolerance and QOL in the patients. Medications were not the reduction in the rate of readmission for patients with HF. changed in any patient during the course of the study. 2. Methods 2.4. Exercise training protocol 2.1. Study design In the interventional group, we collected general data and This study was a prospective randomized study, where a total of parameters using the same methods as we did for the control 75 patients participated from June 2013 to March 2014 in group. In addition, patients in the interventional group received Taichung Veterans General Hospital. We explained in detail the outpatient cardiac rehabilitation for 1 week, before starting purpose and methods of the study to all staff, including home-based cardiac rehabilitation. Home-based cardiac rehabil- cardiologists, physical therapists, and nurses. HF patients with itation was conducted by requesting the interventional group to a reduced ejection fraction (HFrEF) from the general ward, the carry out aerobic exercise at least 3 times per week, for a duration intensive care unit, along with outpatients from the department of of at least 30 minutes each time. Each patient was required to cardiology, all taken from a single medical center in central perform cardiac rehabilitation with an intensity measuring 60% Taiwan were included in this study. The chosen patients were to 80% of peak heart rate, based on the results of his or her initial well informed of the content of the study and were required to CPET. The required exercise intensity was measured subjectively [17] sign a consent form before joining the study. Patients were eligible using a Borg score of 12 to 13. The types of exercises to withdraw from the study at any time. We randomly assigned prescribed were based upon individual interests and abilities, and patients into the control group and interventional group. Data included walking (47.3%), jogging (5.4%), and stationary 2 Chen et al. Medicine (2018) 97:4 www.md-journal.com cycling (47.3%). The control group was instructed to maintain Table 1 both their standard medical care and previous activity levels. Baseline characteristics of enrolled patients. Regular home-based cardiac rehabilitation was to be Control (n= 18) Intervention (n= 19) P performed for at least 3 months in the interventional group, Age, y, mean (SD) 60± 16 61± 11 .878 and all data including CPET and 6MWD were collected after Sex: Male/female (n) 14/4 17/2 .405 completion of the home-based cardiac rehabilitation. Medical Height, cm 163.3± 7.4 164± 8.5 .794 education regarding HF was also provided by the nursing staff Weight, kg 67.8± 18.4 67.3± 11.9 .926 during admission and the case manager in the outpatient Body mass index, kg/m 25.2± 5.7 24.9± 2.6 .807 department both groups. We monitored patients through EF %, mean (SD) 32± 11 36± 9 .369 telephone interviews held every 2 weeks during the study period. VO peak, mL/kg/min 18.9± 4.1 18.2± 4.1 .595 MET 5.4± 1.2 5.5± 1.8 .920 AT, mL/kg/min 12.8± 2.9 12.4± 2.5 .640 2.5. Statistical analysis ICM (n) 3 6 .501 After collecting all data from patients in the study, it was then DCM (n) 15 13 .501 expressed as mean±SD. Continuous variables were analyzed CABG (n) 0 2 .486 MR: I/II/III (n) 6/9/1 6/6/4 .317 using 2-way analysis of variance (ANOVA), and a paired t test AR: I/II (n) 9/4 6/6 .567 was used to compare group differences with baseline values. A P CRT (n) 8 9 1 value <.05 was considered statistically significant. Calculations RHD (n) 1 0 .486 and statistical analyses were carried out using SPSS version 18.0 (SPSS Inc., Chicago, IL). 6MWD= 6-min walk distance (meter), AR= aortic regurgitation, AT= anaerobic threshold, CABG= coronary artery bypass grafting, CRT= cardiac resynchronization therapy, DCM= dilated cardiomyopathy, EF= ejection fraction, ICM= ischemic cardiomyopathy, MET= metabolic equivalent, MR= mitral regurgitation (I= grade I, II= grade II, III= grade III), n= number of subjects, NYHA= New 3. Results York Heart Association, VO peak= peak oxygen uptake, RHD= rheumatic heart disease, SD= Forty patients were randomly assigned to the control group, while standard deviation. 35 patients were randomly selected for the interventional group. In the control group, 3 patients died during the study period, 8 were lost during follow-up, while 11 had incomplete data at the end of the study. As a result, this total of 22 patients in the control group In the interventional group, the patients who had participated were excluded from the study. In the interventional group, 3 in the home-based cardiac rehabilitation program showed a patients could not complete the cardiac rehabilitation course, 4 significant improvement of VO peak by a margin of 14.2% patients refused to receive the final test, and 9 were lost to follow- (18.2±4.1 vs 20.9±6.6mL/kg/min, P=.02), when compared up. Therefore, a total of 16 patients in this group were excluded with baseline. The MLHFQ score and 6MWD also increased from the study. In the end, there were 18 HF cases in the control significantly by the amount of 37% (32.1±10.8 vs 20.2±8.6, group and 19 HF cases in the interventional group. Within the P<.01), and 41m in the interventional group (421±90 vs 462± interventional group, 6 of the 19 patients experienced ischemic 74m, P=.03), respectively. The AT of the interventional group cardiomyopathy, 2 patients had received coronary artery bypass also improved remarkably (12.4±2.5 vs 13.4±2.6mL/kg/min, grafting (CABG) surgery, while 9 of the 19 patients had received P=.005). In the control group, there were visible declines in both cardiac resynchronization therapy (CRT) before the start of the VO peak and MET, but there were no notable changes in AT, cardiac rehabilitation program. Within the control group, 3 of the 6MWD, and MLHFQ scores at the 3-month follow-up. Table 2 18 patients experienced ischemic cardiomyopathy, no patient had displays the changes in exercise tolerance and QOL in both undergone CABG surgery, while 8 of 18 patients had received groups. CRT. One patient in the control group had rheumatic heart disease Data from the noninvasive cardiac output monitor, cardiac with severe mitral stenosis and had received a mitral valve index (CI), SV, TFI, Left Ventricle Contractility Index (ICON), replacement before joining the study. and systemic vascular resistance (SVR) were measured. The data Table 1 summarizes the baseline characteristics of the patients. showed a significant decline in the TFI of both groups after 3 There were no statistically significant differences in age, NYHA months of training (26.5±4.4 vs 22.5±4.11/kV, P=.001 for the Fc, etiology of HF, LVEF, VO peak, AT, or metabolic equivalent interventional group, 27.2±6.8 vs 22.2±3.81/kV, P<.01 for (MET) between the control and intervention patients. the control group). Other parameters showed no remarkable Table 2 The changes of exercise tolerance and quality of life in both groups. Control (N= 18) Intervention (N= 19) Parameters Pre Post P Pre Post P VO peak, mL/kg/min 18.7± 4.2 16.5± 3.7 <.01 18.2± 4.1 20.9± 6.6 .02 METs 5.4± 1.2 4.7± 1.1 <.01 5.5± 1.8 6.0± 1.9 <.01 AT, mL/kg/min 12.8± 2.9 11.7± 4.2 .136 12.4± 2.5 13.4± 2.6 .005 6MWD, m 350± 107 344± 121 .43 421± 90 462± 74 .03 MLHFQ 44.4± 15.3 42.1± 14.0 .33 32.1± 10.8 20.2± 8.6 <.01 6MWD= 6-min walk distance (meter), AT= anaerobic threshold, METs= metabolic equivalent, MLHFQ= Minnesota Living with Heart Failure questionnaire, n= number of subjects, SD= standard deviation, VO peak= peak oxygen uptake. 3 Chen et al. Medicine (2018) 97:4 Medicine Table 3 The change in parameters of heart function in both group. Control (N= 18) Intervention (N= 19) Pre Post P Pre Post P CO, L/min 4.34± 0.95 4.36± 1.09 .45 4.13± 0.45 4.29± 0.67 .15 CI, L/min/m 2.58± 0.54 2.54± 0.61 .46 2.43± 0.28 2.51± 0.39 .20 TFI, L/kV 27.2± 6.8 22.2± 3.8 <.01 26.5± 4.4 22.5± 4.1 .001 ICON 42.5± 19.5 40.3± 15.4 .15 41.6± 12.0 39.3± 11.3 .18 SVR, N.cm 1660± 534 1600± 441 .73 1680± 435 1726± 450 .78 CI= cardiac index, CO= cardiac output, ICON= Index of Contractility, n= number of subjects, SD= standard deviation, SVR= systemic vascular resistance, TFI= thoracic fluid index. differences between the 2 groups. Table 3 summarizes the whether home-based cardiac rehabilitation benefits QOL or not. changes in the parameters of heart function in both groups. According to the results of our study, we observed that patients in According to data obtained from our hospital’s database of the interventional group showed a significantly improved QOL patients’ medical records, the readmission rate for HF within 1 year after 3 months’ follow-up, compared with the control group. The was 34%, and 14% within 90 days during the period 2011 to improvement in QOL is also related to the improvement in 2012. At the 3-month follow-up period, the interventional group exercise tolerance. In addition to the benefits that cardiac showed a significant reduction in the readmission rate within 90 rehabilitation provides, a further advantage it has is the easy days, decreasing from the average rate of 14% to 5%. The home- integration of a home-based cardiac rehabilitation into a patient’s based cardiac rehabilitation program thus lowered the readmission life. A home-based rehabilitation program has a lower impact on rate for HF by nearly 10% for this 90-day follow-up period. a patient’s daily life. In contrast, there was a decrease in VO peak In conclusion, home-based cardiac rehabilitation programs and AT in the control group, which did not show any can not only improve a patient’s aerobic capacity, but they can improvement in QOL. These data may explain, at least in part, also lower the readmission rate of patients with HF. Furthermore, why patients enrolled in the home-based cardiac rehabilitation no adverse events were reported during the home-based program displayed a better QOL. rehabilitation program. 4.4. Improvement in 6-minute walking distance (6MWD) 4. Discussion The 6MWD has been proposed as an easy, well-tolerated, and [25] alternative method for evaluating functional capacity. Previ- 4.1. Major findings ous studies have demonstrated that higher rates of death and Our study demonstrates that home-based cardiac rehabilitation hospitalization were found in HF patients with a 6MWD of less results in a statistically significant improvement in both VO peak [26] than 300m. We showed that a 6MWD greater than 300m and AT, which in turn was associated with improvements in may indicate a better prognosis. The meta-analysis offered strong functional capacity and QOL. evidence that the 6MWD was responsive to change in clinical status following cardiac rehabilitation, with an estimated mean [27] difference in distance of 60.43m. In our study, 6MWD results 4.2. Improvement in VO peak and anaerobic threshold improved from 420 to 461m after patients received home-based In our study, home-based cardiac rehabilitation was associated cardiac rehabilitation for 3 months. This increased distance of 41 with a remarkable improvement in VO peak, AT, and QOL. m on the 6MWD test was associated with an increase in both That same result could also be observed in outpatient-based VO peak and AT, after the home-based rehabilitation program. [18,19] 2 cardiac rehabilitation. The improvement exercise tolerance patients with HFrEF can be well-explained by the improvement VO peak and AT. Nevertheless, previous studies have shown 2 4.5. Changes in heart function after rehabilitation that approximately 20% to 50% of patients with HF are unable Previous studies have shown that exercise training offers no to comply with hospital-based cardiac rehabilitation programs in benefits toward heart function, including cardiac output, SV, and [20] the first 3 to 6 months. As a result, home-based cardiac [28,29] LVEF. Only 1 published study showed there was significant rehabilitation programs are shown to be more convenient, and improvement in LVEF in both hospital-based and home-based may be an acceptable alternative option for patients with chronic [30] exercise programs. However, the noninvasive cardiac output [21] HF. Such home-based programs may therefore be a more measurement data showed no significant change in our study. The [22] practical strategy for motivating patients to continue exercise. results of this study were thus similar to the findings of previous Several published studies have shown that home-based exercise research. Short-term, home-based cardiac rehabilitation no [1] training could improve both VO peak and 6MWD. This is significant benefits to cardiac physiologic function. However, similar to our results, which showed an improved VO peak of more long-term research is still required in order to evaluate the 2.7mL/kg/min, an improved AT of 1.2mL/kg/min, along with an effects of such exercise programs on cardiac physiologic function. improvement in 6MWD of 41m. In our study, both groups experienced a lower TFI at 3 months, compared with that at the beginning of the study. Traditional 4.3. Improvement in QOL treatment for HF, including medical therapy, diet education, and Several previous studies have shown that rehabilitation programs lifestyle modification, still provided benefits toward the control of can lead to a statistically significant improvement in QOL for fluid status in patients with HF. Although short-term rehabilitation [20,23,24] patients with HF. However, it remains controversial had no effect on heart function, the improvement in both VO peak 4 Chen et al. Medicine (2018) 97:4 www.md-journal.com [13] O’Connor CM, Whellan DJ, Lee KL, et al. Efficacy and safety of exercise and AT may play an important role in functional capacity training in patients with chronic heart failure: HF-ACTION randomized and QOL. controlled trial. JAMA 2009;301:1439–50. [14] Maiorana , O’Driscoll G, Dembo L, et al. Effect of aerobic and resistance exercise training on vascular function in heart failure. Am J Physiol Heart 4.6. Limitations Circ Physiol 2000;279:H1999–2005. [15] Selig SE, Carey MF, Menzies DG, et al. Moderate-intensity resistance A limited number of subjects, high rate of loss follow-up, and a exercise training in patients with chronic heart failure improves strength, predominantly male subject pool are the limitations within this endurance, heart rate variability, and forearm blood flow. J Card Fail 2004;10:21–30. study. In addition, the study period may have been too short to [16] Jolly K, Taylor RS, Lip GY, et al. 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Home-based cardiac rehabilitation improves quality of life, aerobic capacity, and readmission rates in patients with chronic heart failure

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Wolters Kluwer Health
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Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc.
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0025-7974
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Abstract

Background: Exercise tolerance and cardiac output have a major impact on the quality of life (QOL) of patients experiencing heart failure (HF). Home-based cardiac rehabilitation can significantly improve not only exercise tolerance but also peak oxygen uptake (VO peak), and the QOL in patients with HF. The aim of this prospective study was to evaluate the beneficial effects of home-based cardiac rehabilitation on the quality of medical care in patients with chronic HF. Methods: This study was a randomized prospective trial. HF patients with a left ventricular ejection fraction (LVEF) of less than 50% were included in this study. We randomly assigned patients to the control group (n=18) and the interventional group (n=19). Within the interventional group, we arranged individualized rehabilitation programs, including home-based cardiac rehabilitation, diet education, and management of daily activity over a 3-month period. Information such as general data, laboratory data, Cardiopulmonary Exercise Test (CPET) results, Six-minute Walk Test (6MWT) results, and the scores for the Minnesota Living with Heart Failure Questionnaire (MLHFQ) before and after the intervention, was collected from all patients in this study. Results: Patients enrolled in the home-based cardiac rehabilitation programs displayed statistically significant improvement in VO peak (18.2±4.1 vs 20.9±6.6mL/kg/min, P=.02), maximal 6-Minute Walking Distance (6MWD) (421±90 vs 462±74m, P=.03), anaerobic threshold (12.4±2.5 vs 13.4±2.6mL/kg/min, P=.005), and QOL. In summary, patients receiving home-based cardiac rehabilitation experienced a 14.2% increase in VO peak, a 37% increase in QOL score, and an improvement of 41m on the 6MWD test. The 90-day readmission rate for patients reduced to 5% from 14% after receiving cardiac rehabilitation. Conclusion: Home-based cardiac rehabilitation offered the most improved results in functional capacity, QOL, and a reduced the rate of readmission within 90 days. Abbreviations: 6MWD = six-minute walk distance, 6MWT = six-minute walk test, AHA = American Heart Association, AT = anaerobic threshold, CABG = coronary artery bypass grafting, CI = cardiac index, CO = cardiac output, CPET = cardiopulmonary exercise test, CRT = cardiac resynchronization therapy, EF = ejection fraction, HF = heart failure, HFrEF = heart failure with reduced ejection fraction, ICON = left ventricle contractility index, IRB = Institutional Review Board, LVEF = left ventricle ejection fraction, MET = metabolic equivalent, MLHFQ = Minnesota Living With HF Questionnaire, NYHA Fc = New York Heart Association Functional Classification, VO peak = peak oxygen uptake, QOL = quality of life, SV = stroke volume, SVR = systemic vascular resistance, TFI = thoracic fluid index. Keywords: heart failure, home-based cardiac rehabilitation, quality of medical care Editor: Yen-Hung Lin. Both YWC and CYW contributed equally to this article. The principal investigator, JLH, had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Funding/support: This study was supported in part by grants from the Taiwan National Science Council (NSC-100–2314-B-075A-005-MY3, 101–2314-B-758–002-, 102–2314-B-758–001-, 103–2314-B-758–001-), and grants from the Taichung Veterans General Hospital (TCVGH-1033106C, 1043106C, 1043102B, 1053106C, 1063106C). This study was registered at the US National Institutes of Health (ClinicalTrials.gov) # NCT02928783. The authors have no potential conflicts of interest. a b c Department of Physical Medicine and Rehabilitation, Cardiovascular Center, Taichung Veterans General Hospital, Department of Health Business Administration, Hung Kuang University, Taichung, Institute of Clinical Medicine, and Cardiovascular Research Institute, Department of Medicine, School of Medicine, National Yang- Ming University, Taipei, Department of Physical Medicine and Rehabilitation, School of Medicine, National Defense Medical Center, Taipei, Taiwan. Correspondence: Jin-Long Huang, Cardiovascular Center, Taichung Veterans General Hospital, 1650 Taiwan Boulevard Sect. 4, Taichung 40705, Taiwan (e-mail: golden@vghtc.gov.tw); Shin-Tsu Chang, Department of Physical Medicine and Rehabilitation, Taichung Veterans General Hospital, 1650 Taiwan Boulevard Sect. 4, Taichung 40705, Taiwan (e-mail: rehchang@vghtc.gov.tw). Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Medicine (2018) 97:4(e9629) Received: 2 May 2017 / Received in final form: 26 December 2017 / Accepted: 27 December 2017 http://dx.doi.org/10.1097/MD.0000000000009629 1 Chen et al. Medicine (2018) 97:4 Medicine 1. Introduction were scrambled before being made available to researchers in order to ensure that individual identifying information at any Heart failure (HF) is a common yet complicated disease resulting level could not be obtained from the database. Clinical data of from multiple etiologies, including coronary artery disease, patients in the study were collected by both nurses and case hypertension, and certain metabolic disorders, leading to over managers within the cardiology department. The study then [1] 10,000 deaths each year in Taiwan. HF is not curable and proceeded after obtaining permission from the hospital’s requires long-term evaluation and medical care. The incidence Institutional Review Board (IRB). and prevalence rates of HF are increasing annually due to an aging populations, along with an increase in the prevalence rate of chronic systemic disorders, including hypertension, type 2 2.2. Study subjects [2,3] diabetes mellitus, and hyperlipidemia. The average age of HF patients in either the ward or outpatient department with a patients with HF is also decreasing. The therapeutic goal of HF is left ventricle ejection fraction (LVEF) of less than 50% were to avoid any aggravating symptoms, improve health-related included in this study. We evaluated the functional stage of HF [1,4] quality of life (QOL), and decrease the costs of health care. using the New York Heart Association Functional Classification Although several reports have suggested that the mortality rate (NYHA Fc) guidelines. Patients experiencing NYHA Fc IV, of patients with HF is improving, the overall mortality rate still pregnancy, a high bedridden status, musculoskeletal system remains high. It has been estimated that more than 23% of problems, and disabilities for which exercise is contraindicated, [5] rehospitalizations for HF occur within 60 to 90 days, while less were excluded from this study. HF patients with a preserved [5– than 50% of patients with HF will survive for more than 5 years. ejection fraction (LVEF >50%) were excluded from this study 7] According to the registry data of the American Heart Association due to a difficulty with performing a dedicated evaluation. [7] (AHA) for Projections, the prevalence of HF will increase by 46% between 2012 and 2030, where patients with HF who are 2.3. Measurements younger than 65 years old will have a 6 to 9 times greater risk of experiencing sudden cardiac death when compared with that of the All patients had to sign a consent form before joining this study. [7] general population. The huge medical expense of HF leads to a We recorded each patient’s general data, including body height, heavy economic burden on both the patient’s family and the health body weight, and laboratory data during their admission and care system. Previous studies have shown that some symptoms of outpatient visits. We then evaluated each patients’ QOL using the HF, including fatigue and dyspnea on exertion, make the daily Minnesota Living With HF Questionnaire (MLHFQ) during the [3] activities of patients with HF intolerable. Additionally, the study period. We also monitored several parameters including aggravated symptoms of HF may cause depression, anxiety, and a VO peak, anaerobic threshold (AT) through use of the [8–10] compromised QOL for the patient. Cardiopulmonary Exercise Test (CPET) and the 6 Minutes Several studies have shown that cardiopulmonary rehabilita- Walking Test (6MWT) in order to evaluate the change exercise tion programs are both safe and effective for improving tolerance during the study period. According to the data obtained functional capacity and QOL, as well as for reducing the from both the CPET and 6MWT, we designed an individualized readmission rates and all-cause mortality of patients with home-based cardiac rehabailitation program according to each [1,11,12] HF. The results of many clinical trials have established patient’s willingness. In addition, we monitored the parameters of the benefits of hospital-based cardiac rehabilitation for patients their hemodynamics status, including stroke volume (SV), LVEF, [13–15] with HF. Home-based cardiac rehabilitation may be more and thoracic fluid index (TFI), by using a noninvasive cardiac accessible and acceptable when compared with hospital-based output monitor (Aesculon [Osypka Medical, Berlin, Germany]) cardiac rehabilitation. However, home-based rehabilitation during the study period. We measured the patients’ general data programs have not been widely studied and their training effects and physiologic parameters in both groups at the beginning of the [1,13,16] remain unclear. Thus, the purpose of this study was to study and also 3 months later. Finally, we compared all collected evaluate the effects of home-based cardiac rehabilitation on the data from both groups to evaluate both the change of exercise improvement in functional capacity, enhancement in QOL, and tolerance and QOL in the patients. Medications were not the reduction in the rate of readmission for patients with HF. changed in any patient during the course of the study. 2. Methods 2.4. Exercise training protocol 2.1. Study design In the interventional group, we collected general data and This study was a prospective randomized study, where a total of parameters using the same methods as we did for the control 75 patients participated from June 2013 to March 2014 in group. In addition, patients in the interventional group received Taichung Veterans General Hospital. We explained in detail the outpatient cardiac rehabilitation for 1 week, before starting purpose and methods of the study to all staff, including home-based cardiac rehabilitation. Home-based cardiac rehabil- cardiologists, physical therapists, and nurses. HF patients with itation was conducted by requesting the interventional group to a reduced ejection fraction (HFrEF) from the general ward, the carry out aerobic exercise at least 3 times per week, for a duration intensive care unit, along with outpatients from the department of of at least 30 minutes each time. Each patient was required to cardiology, all taken from a single medical center in central perform cardiac rehabilitation with an intensity measuring 60% Taiwan were included in this study. The chosen patients were to 80% of peak heart rate, based on the results of his or her initial well informed of the content of the study and were required to CPET. The required exercise intensity was measured subjectively [17] sign a consent form before joining the study. Patients were eligible using a Borg score of 12 to 13. The types of exercises to withdraw from the study at any time. We randomly assigned prescribed were based upon individual interests and abilities, and patients into the control group and interventional group. Data included walking (47.3%), jogging (5.4%), and stationary 2 Chen et al. Medicine (2018) 97:4 www.md-journal.com cycling (47.3%). The control group was instructed to maintain Table 1 both their standard medical care and previous activity levels. Baseline characteristics of enrolled patients. Regular home-based cardiac rehabilitation was to be Control (n= 18) Intervention (n= 19) P performed for at least 3 months in the interventional group, Age, y, mean (SD) 60± 16 61± 11 .878 and all data including CPET and 6MWD were collected after Sex: Male/female (n) 14/4 17/2 .405 completion of the home-based cardiac rehabilitation. Medical Height, cm 163.3± 7.4 164± 8.5 .794 education regarding HF was also provided by the nursing staff Weight, kg 67.8± 18.4 67.3± 11.9 .926 during admission and the case manager in the outpatient Body mass index, kg/m 25.2± 5.7 24.9± 2.6 .807 department both groups. We monitored patients through EF %, mean (SD) 32± 11 36± 9 .369 telephone interviews held every 2 weeks during the study period. VO peak, mL/kg/min 18.9± 4.1 18.2± 4.1 .595 MET 5.4± 1.2 5.5± 1.8 .920 AT, mL/kg/min 12.8± 2.9 12.4± 2.5 .640 2.5. Statistical analysis ICM (n) 3 6 .501 After collecting all data from patients in the study, it was then DCM (n) 15 13 .501 expressed as mean±SD. Continuous variables were analyzed CABG (n) 0 2 .486 MR: I/II/III (n) 6/9/1 6/6/4 .317 using 2-way analysis of variance (ANOVA), and a paired t test AR: I/II (n) 9/4 6/6 .567 was used to compare group differences with baseline values. A P CRT (n) 8 9 1 value <.05 was considered statistically significant. Calculations RHD (n) 1 0 .486 and statistical analyses were carried out using SPSS version 18.0 (SPSS Inc., Chicago, IL). 6MWD= 6-min walk distance (meter), AR= aortic regurgitation, AT= anaerobic threshold, CABG= coronary artery bypass grafting, CRT= cardiac resynchronization therapy, DCM= dilated cardiomyopathy, EF= ejection fraction, ICM= ischemic cardiomyopathy, MET= metabolic equivalent, MR= mitral regurgitation (I= grade I, II= grade II, III= grade III), n= number of subjects, NYHA= New 3. Results York Heart Association, VO peak= peak oxygen uptake, RHD= rheumatic heart disease, SD= Forty patients were randomly assigned to the control group, while standard deviation. 35 patients were randomly selected for the interventional group. In the control group, 3 patients died during the study period, 8 were lost during follow-up, while 11 had incomplete data at the end of the study. As a result, this total of 22 patients in the control group In the interventional group, the patients who had participated were excluded from the study. In the interventional group, 3 in the home-based cardiac rehabilitation program showed a patients could not complete the cardiac rehabilitation course, 4 significant improvement of VO peak by a margin of 14.2% patients refused to receive the final test, and 9 were lost to follow- (18.2±4.1 vs 20.9±6.6mL/kg/min, P=.02), when compared up. Therefore, a total of 16 patients in this group were excluded with baseline. The MLHFQ score and 6MWD also increased from the study. In the end, there were 18 HF cases in the control significantly by the amount of 37% (32.1±10.8 vs 20.2±8.6, group and 19 HF cases in the interventional group. Within the P<.01), and 41m in the interventional group (421±90 vs 462± interventional group, 6 of the 19 patients experienced ischemic 74m, P=.03), respectively. The AT of the interventional group cardiomyopathy, 2 patients had received coronary artery bypass also improved remarkably (12.4±2.5 vs 13.4±2.6mL/kg/min, grafting (CABG) surgery, while 9 of the 19 patients had received P=.005). In the control group, there were visible declines in both cardiac resynchronization therapy (CRT) before the start of the VO peak and MET, but there were no notable changes in AT, cardiac rehabilitation program. Within the control group, 3 of the 6MWD, and MLHFQ scores at the 3-month follow-up. Table 2 18 patients experienced ischemic cardiomyopathy, no patient had displays the changes in exercise tolerance and QOL in both undergone CABG surgery, while 8 of 18 patients had received groups. CRT. One patient in the control group had rheumatic heart disease Data from the noninvasive cardiac output monitor, cardiac with severe mitral stenosis and had received a mitral valve index (CI), SV, TFI, Left Ventricle Contractility Index (ICON), replacement before joining the study. and systemic vascular resistance (SVR) were measured. The data Table 1 summarizes the baseline characteristics of the patients. showed a significant decline in the TFI of both groups after 3 There were no statistically significant differences in age, NYHA months of training (26.5±4.4 vs 22.5±4.11/kV, P=.001 for the Fc, etiology of HF, LVEF, VO peak, AT, or metabolic equivalent interventional group, 27.2±6.8 vs 22.2±3.81/kV, P<.01 for (MET) between the control and intervention patients. the control group). Other parameters showed no remarkable Table 2 The changes of exercise tolerance and quality of life in both groups. Control (N= 18) Intervention (N= 19) Parameters Pre Post P Pre Post P VO peak, mL/kg/min 18.7± 4.2 16.5± 3.7 <.01 18.2± 4.1 20.9± 6.6 .02 METs 5.4± 1.2 4.7± 1.1 <.01 5.5± 1.8 6.0± 1.9 <.01 AT, mL/kg/min 12.8± 2.9 11.7± 4.2 .136 12.4± 2.5 13.4± 2.6 .005 6MWD, m 350± 107 344± 121 .43 421± 90 462± 74 .03 MLHFQ 44.4± 15.3 42.1± 14.0 .33 32.1± 10.8 20.2± 8.6 <.01 6MWD= 6-min walk distance (meter), AT= anaerobic threshold, METs= metabolic equivalent, MLHFQ= Minnesota Living with Heart Failure questionnaire, n= number of subjects, SD= standard deviation, VO peak= peak oxygen uptake. 3 Chen et al. Medicine (2018) 97:4 Medicine Table 3 The change in parameters of heart function in both group. Control (N= 18) Intervention (N= 19) Pre Post P Pre Post P CO, L/min 4.34± 0.95 4.36± 1.09 .45 4.13± 0.45 4.29± 0.67 .15 CI, L/min/m 2.58± 0.54 2.54± 0.61 .46 2.43± 0.28 2.51± 0.39 .20 TFI, L/kV 27.2± 6.8 22.2± 3.8 <.01 26.5± 4.4 22.5± 4.1 .001 ICON 42.5± 19.5 40.3± 15.4 .15 41.6± 12.0 39.3± 11.3 .18 SVR, N.cm 1660± 534 1600± 441 .73 1680± 435 1726± 450 .78 CI= cardiac index, CO= cardiac output, ICON= Index of Contractility, n= number of subjects, SD= standard deviation, SVR= systemic vascular resistance, TFI= thoracic fluid index. differences between the 2 groups. Table 3 summarizes the whether home-based cardiac rehabilitation benefits QOL or not. changes in the parameters of heart function in both groups. According to the results of our study, we observed that patients in According to data obtained from our hospital’s database of the interventional group showed a significantly improved QOL patients’ medical records, the readmission rate for HF within 1 year after 3 months’ follow-up, compared with the control group. The was 34%, and 14% within 90 days during the period 2011 to improvement in QOL is also related to the improvement in 2012. At the 3-month follow-up period, the interventional group exercise tolerance. In addition to the benefits that cardiac showed a significant reduction in the readmission rate within 90 rehabilitation provides, a further advantage it has is the easy days, decreasing from the average rate of 14% to 5%. The home- integration of a home-based cardiac rehabilitation into a patient’s based cardiac rehabilitation program thus lowered the readmission life. A home-based rehabilitation program has a lower impact on rate for HF by nearly 10% for this 90-day follow-up period. a patient’s daily life. In contrast, there was a decrease in VO peak In conclusion, home-based cardiac rehabilitation programs and AT in the control group, which did not show any can not only improve a patient’s aerobic capacity, but they can improvement in QOL. These data may explain, at least in part, also lower the readmission rate of patients with HF. Furthermore, why patients enrolled in the home-based cardiac rehabilitation no adverse events were reported during the home-based program displayed a better QOL. rehabilitation program. 4.4. Improvement in 6-minute walking distance (6MWD) 4. Discussion The 6MWD has been proposed as an easy, well-tolerated, and [25] alternative method for evaluating functional capacity. Previ- 4.1. Major findings ous studies have demonstrated that higher rates of death and Our study demonstrates that home-based cardiac rehabilitation hospitalization were found in HF patients with a 6MWD of less results in a statistically significant improvement in both VO peak [26] than 300m. We showed that a 6MWD greater than 300m and AT, which in turn was associated with improvements in may indicate a better prognosis. The meta-analysis offered strong functional capacity and QOL. evidence that the 6MWD was responsive to change in clinical status following cardiac rehabilitation, with an estimated mean [27] difference in distance of 60.43m. In our study, 6MWD results 4.2. Improvement in VO peak and anaerobic threshold improved from 420 to 461m after patients received home-based In our study, home-based cardiac rehabilitation was associated cardiac rehabilitation for 3 months. This increased distance of 41 with a remarkable improvement in VO peak, AT, and QOL. m on the 6MWD test was associated with an increase in both That same result could also be observed in outpatient-based VO peak and AT, after the home-based rehabilitation program. [18,19] 2 cardiac rehabilitation. The improvement exercise tolerance patients with HFrEF can be well-explained by the improvement VO peak and AT. Nevertheless, previous studies have shown 2 4.5. Changes in heart function after rehabilitation that approximately 20% to 50% of patients with HF are unable Previous studies have shown that exercise training offers no to comply with hospital-based cardiac rehabilitation programs in benefits toward heart function, including cardiac output, SV, and [20] the first 3 to 6 months. As a result, home-based cardiac [28,29] LVEF. Only 1 published study showed there was significant rehabilitation programs are shown to be more convenient, and improvement in LVEF in both hospital-based and home-based may be an acceptable alternative option for patients with chronic [30] exercise programs. However, the noninvasive cardiac output [21] HF. Such home-based programs may therefore be a more measurement data showed no significant change in our study. The [22] practical strategy for motivating patients to continue exercise. results of this study were thus similar to the findings of previous Several published studies have shown that home-based exercise research. Short-term, home-based cardiac rehabilitation no [1] training could improve both VO peak and 6MWD. This is significant benefits to cardiac physiologic function. However, similar to our results, which showed an improved VO peak of more long-term research is still required in order to evaluate the 2.7mL/kg/min, an improved AT of 1.2mL/kg/min, along with an effects of such exercise programs on cardiac physiologic function. improvement in 6MWD of 41m. In our study, both groups experienced a lower TFI at 3 months, compared with that at the beginning of the study. Traditional 4.3. Improvement in QOL treatment for HF, including medical therapy, diet education, and Several previous studies have shown that rehabilitation programs lifestyle modification, still provided benefits toward the control of can lead to a statistically significant improvement in QOL for fluid status in patients with HF. Although short-term rehabilitation [20,23,24] patients with HF. However, it remains controversial had no effect on heart function, the improvement in both VO peak 4 Chen et al. Medicine (2018) 97:4 www.md-journal.com [13] O’Connor CM, Whellan DJ, Lee KL, et al. 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