BACKGROUND: Coronary heart disease (CHD) is the most common cause of death globally. However, with falling CHD mortality rates, an increasing number of people living with CHD may need support to manage their symptoms and prognosis. Exercise-based cardiac rehabilitation (CR) aims to improve the health and outcomes of people with CHD. This is an update of a Cochrane Review previously published in 2016.
OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of exercise-based CR (exercise training alone or in combination with psychosocial or educational interventions) compared with 'no exercise' control, on mortality, morbidity and health-related quality of life (HRQoL) in people with CHD.
SEARCH METHODS: We updated searches from the previous Cochrane Review, by searching CENTRAL, MEDLINE, Embase, and two other databases in September 2020. We also searched two clinical trials registers in June 2021.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) of exercise-based interventions with at least six months' follow-up, compared with 'no exercise' control. The study population comprised adult men and women who have had a myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI), or have angina pectoris, or coronary artery disease.
DATA COLLECTION AND ANALYSIS: We screened all identified references, extracted data and assessed risk of bias according to Cochrane methods. We stratified meta-analysis by duration of follow-up: short-term (6 to 12 months); medium-term (> 12 to 36 months); and long-term ( > 3 years), and used meta-regression to explore potential treatment effect modifiers. We used GRADE for primary outcomes at 6 to 12 months (the most common follow-up time point). MAIN RESULTS: This review included 85 trials which randomised 23,430 people with CHD. This latest update identified 22 new trials (7795 participants). The population included predominantly post-MI and post-revascularisation patients, with a mean age ranging from 47 to 77 years. In the last decade, the median percentage of women with CHD has increased from 11% to 17%, but females still account for a similarly small percentage of participants recruited overall ( < 15%). Twenty-one of the included trials were performed in low- and middle-income countries (LMICs). Overall trial reporting was poor, although there was evidence of an improvement in quality over the last decade. The median longest follow-up time was 12 months (range 6 months to 19 years). At short-term follow-up (6 to 12 months), exercise-based CR likely results in a slight reduction in all-cause mortality (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.73 to 1.04; 25 trials; moderate certainty evidence), a large reduction in MI (RR 0.72, 95% CI 0.55 to 0.93; 22 trials; number needed to treat for an additional beneficial outcome (NNTB) 75, 95% CI 47 to 298; high certainty evidence), and a large reduction in all-cause hospitalisation (RR 0.58, 95% CI 0.43 to 0.77; 14 trials; NNTB 12, 95% CI 9 to 21; moderate certainty evidence). Exercise-based CR likely results in little to no difference in risk of cardiovascular mortality (RR 0.88, 95% CI 0.68 to 1.14; 15 trials; moderate certainty evidence), CABG (RR 0.99, 95% CI 0.78 to 1.27; 20 trials; high certainty evidence), and PCI (RR 0.86, 95% CI 0.63 to 1.19; 13 trials; moderate certainty evidence) up to 12 months' follow-up. We are uncertain about the effects of exercise-based CR on cardiovascular hospitalisation, with a wide confidence interval including considerable benefit as well as harm (RR 0.80, 95% CI 0.41 to 1.59; low certainty evidence). There was evidence of substantial heterogeneity across trials for cardiovascular hospitalisations (I2 = 53%), and of small study bias for all-cause hospitalisation, but not for all other outcomes. At medium-term follow-up, although there may be little to no difference in all-cause mortality (RR 0.90, 95% CI 0.80 to 1.02; 15 trials), MI (RR 1.07, 95% CI 0.91 to 1.27; 12 trials), PCI (RR 0.96, 95% CI 0.69 to 1.35; 6 trials), CABG (RR 0.97, 95% CI 0.77 to 1.23; 9 trials), and all-cause hospitalisation (RR 0.92, 95% CI 0.82 to 1.03; 9 trials), a large reduction in cardiovascular mortality was found (RR 0.77, 95% CI 0.63 to 0.93; 5 trials). Evidence is uncertain for difference in risk of cardiovascular hospitalisation (RR 0.92, 95% CI 0.76 to 1.12; 3 trials). At long-term follow-up, although there may be little to no difference in all-cause mortality (RR 0.91, 95% CI 0.75 to 1.10), exercise-based CR may result in a large reduction in cardiovascular mortality (RR 0.58, 95% CI 0.43 to 0.78; 8 trials) and MI (RR 0.67, 95% CI 0.50 to 0.90; 10 trials). Evidence is uncertain for CABG (RR 0.66, 95% CI 0.34 to 1.27; 4 trials), and PCI (RR 0.76, 95% CI 0.48 to 1.20; 3 trials). Meta-regression showed benefits in outcomes were independent of CHD case mix, type of CR, exercise dose, follow-up length, publication year, CR setting, study location, sample size or risk of bias. There was evidence that exercise-based CR may slightly increase HRQoL across several subscales (SF-36 mental component, physical functioning, physical performance, general health, vitality, social functioning and mental health scores) up to 12 months' follow-up; however, these may not be clinically important differences. The eight trial-based economic evaluation studies showed exercise-based CR to be a potentially cost-effective use of resources in terms of gain in quality-adjusted life years (QALYs).
AUTHORS' CONCLUSIONS: This updated Cochrane Review supports the conclusions of the previous version, that exercise-based CR provides important benefits to people with CHD, including reduced risk of MI, a likely small reduction in all-cause mortality, and a large reduction in all-cause hospitalisation, along with associated healthcare costs, and improved HRQoL up to 12 months' follow-up. Over longer-term follow-up, benefits may include reductions in cardiovascular mortality and MI. In the last decade, trials were more likely to include females, and be undertaken in LMICs, increasing the generalisability of findings. Well-designed, adequately-reported RCTs of CR in people with CHD more representative of usual clinical practice are still needed. Trials should explicitly report clinical outcomes, including mortality and hospital admissions, and include validated HRQoL outcome measures, especially over longer-term follow-up, and assess costs and cost-effectiveness.
OBJECTIVES: To determine the contemporary effectiveness of exercise-based cardiac rehabilitation (CR) in terms of all-cause mortality, cardiovascular mortality and hospital admissions.
DATA SOURCES: Studies included in or meeting the entry criteria for the 2016 Cochrane review of exercise-based CR in patients with coronary artery disease.
STUDY ELIGIBILITY CRITERIA: Randomised controlled trials (RCTs) of exercise-based CR versus a no-exercise control whose participants were recruited after the year 2000.
STUDY APPRAISAL AND SYNTHESIS METHODS: Two separate reviewers independently screened the characteristics of studies. One reviewer quality appraised any new studies and assessed their risk of bias using the Cochrane Collaboration's recommended risk of bias tool. Data were reported as the risk difference (95% CI).
RESULTS: We included 22 studies with 4834 participants (mean age 59.5 years, 78.4% male). We found no differences in outcomes between exercise-based CR and a no-exercise control at their longest follow-up period for: all-cause mortality (19 studies; n=4194; risk difference 0.00, 95% CI -0.02 to 0.01, P=0.38) or cardiovascular mortality (9 studies; n=1182; risk difference -0.01, 95% CI -0.02 to 0.01, P=0.25). We found a small reduction in hospital admissions of borderline statistical significance (11 studies; n=1768; risk difference -0.05, 95% CI -0.10 to -0.00, P=0.05).
CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Our analysis indicates conclusively that the current approach to exercise-based CR has no effect on all-cause mortality or cardiovascular mortality, when compared with a no-exercise control. There may be a small reduction in hospital admissions following exercise-based CR that is unlikely to be clinically important.
PROSPERO REGISTRATION NUMBER: CRD42017073616.
Background. Although earlier reviews establish that patients with coronary heart disease (CHD) respond well to cardiac rehabilitation (CR), the comparative effectiveness of different CR programs or their individual core components of CR have not been evaluated. Methods. A systematic review and network meta-analysis (NMA) of randomized controlled trials (RCTs) evaluating the core components of CR (nutritional counseling (NC), risk factor modification (RFM), psychosocial management (PM), patient education (PE), and exercise training (ET)) was undertaken. The core components were evaluated individually and as part of broader CR treatment categories ('exercise-only' CR programs, 'comprehensive' CR programs, and 'secondary prevention programs without exercise'). Published RCTs were identified from database inception dates (Medline, Medline In-Process, the Cochrane database, Embase, CINAHL, Sci-Expanded, PsychINFO, the Web of Science) to July 2014. Endpoints included measures of mortality (all-cause and CV) and morbidity (myocardial infarction (MI), revascularization, and hospitalization). Hazard ratios (HR) and 95% credible intervals (CrIs) were used as summary measures. Findings. 136 trials (50,054 participants) and 169 trials (62,149 participants) were included for the NMAs of the overall CR treatment strategies and for the core components of CR respectively. 'Exercise-only' and 'comprehensive' CR programs significantly reduced the hazards of all-cause mortality, CV mortality, total MI, fatal MI, non-fatal MI, revascularization, total and CV hospitalization by 25-54% when compared to usual care, and significantly reduced the hazard of all-cause mortality by 23%-26% when compared to 'secondary prevention programs without exercise'. 'Secondary prevention programs without exercise' significantly reduced the hazards of all-cause and CV mortality, total MI, non-fatal MI, all-cause and CV hospitalization by 20%-43% when compared to usual care. The core component of PM significantly reduced the hazards of all-cause mortality, all-cause and CV hospitalization by 31%, 33% and 50% respectively. RFM and PE significantly reduced the hazards of total MI and all-cause hospitalization by 37% and 23% respectively. Interpretation. These findings confirm the central role of CR in patients with CHD, emphasize the central role of exercise training in CR, elevate the role of other key CR core components, especially psychosocial management, and establish the superiority of exercise-based CR programs to 'secondary prevention programs without exercise'. (PsycINFO Database Record (c) 2017 APA, all rights reserved)
BACKGROUND: Exercise-based cardiac rehabilitation (CR) has been recognized as an essential component of the treatment for coronary heart disease (CHD). Determining the efficacy of modern alternative treatment methods is the key to developing exercise-based CR programs.
METHODS: Studies published through June 6, 2016, were identified using MEDLINE, EMBASE, and the Cochrane Library. English-language articles regarding the efficacy of different modes of CR in patients with CHD were included in this analysis. Two investigators independently reviewed abstracts and full-text articles and extracted data from the studies. According to the categories described by prior Cochrane reviews, exercise-based CR was classified into center-based CR, home-based CR, tele-based CR, and combined CR for this analysis. Outcomes included all-cause mortality, cardiovascular death, recurrent fatal and/or nonfatal myocardial infarction, recurrent cardiac artery bypass grafting, recurrent percutaneous coronary intervention (PCI), and hospital readmissions.
RESULTS: Sixty randomized clinical trials (n = 19,411) were included in the analysis. Network meta-analysis (NMA) demonstrated that only center-based CR significantly reduced all-cause mortality (center-based: RR = 0.76 [95% CI 0.64-0.90], p = 0.002) compared to usual care. Other modes of CR were not significantly different from usual care with regard to their ability to reduce mortality. Treatment ranking indicated that combined CR exhibited the highest probability (86.9%) of being the most effective mode, but this finding was not statistically significant due to the small sample size (combined: RR = 0.50 [95% CI 0.20-1.27], p = 0.146).
CONCLUSIONS: Current evidence suggests that center-based CR is acceptable for patients with CHD. As home- and tele-based CR can save time, money, effort, and resources and may be preferred by patients, their efficacy should be investigated further in subsequent studies.
A systematic review and network meta-analysis (NMA) of randomized controlled trials (RCTs) evaluating the core components of cardiac rehabilitation (CR), nutritional counseling (NC), risk factor modification (RFM), psychosocial management (PM), patient education (PE), and exercise training (ET)) was undertaken. Published RCTs were identified from database inception dates to April 2017, and risk of bias assessed using Cochrane’s tool. Endpoints included mortality (all-cause and cardiovascular (CV)) and morbidity (fatal and non-fatal myocardial infarction (MI), coronary artery bypass surgery (CABG), percutaneous coronary intervention (PCI), and hospitalization (all-cause and CV)). Meta-regression models decomposed treatment effects into the main effects of core components, and two-way or all-way interactions between them. Ultimately, 148 RCTs (50,965 participants) were included. Main effects models were best fitting for mortality (e.g., for all-cause, specifically PM (hazard ratio HR = 0.68, 95% credible interval CrI = 0.54–0.85) and ET (HR = 0.75, 95% CrI = 0.60–0.92) components effective), MI (e.g., for all-cause, specifically PM (hazard ratio HR = 0.76, 95% credible interval CrI = 0.57–0.99), ET (HR = 0.75, 95% CrI = 0.56–0.99) and PE (HR = 0.68, 95% CrI = 0.47–0.99) components effective) and hospitalization (e.g., all-cause, PM (HR = 0.76, 95% CrI = 0.58–0.96) effective). For revascularization (including CABG and PCI individually), the full interaction model was best-fitting. Given that each component, individual or in combination, was associated with mortality and/or morbidity, recommendations for comprehensive CR are warranted.
Los programas de rehabilitación cardiaca (RC) que ofrecen prevención secundaria para enfermedades cardiovasculares (ECV) aconsejan comportamientos de estilo de vida saludable, con técnicas de cambio de comportamiento (BCT) de metas y planificación, retroalimentación y monitoreo y apoyo social recomendado. Se necesita más información sobre el uso del BCT en la CR en el hogar para apoyar estos programas en la práctica. OBJETIVO: Identificar y describir el uso de BCT en programas de RC domiciliarios. DISEÑO Y AJUSTE: Se identificaron ensayos controlados aleatorios de RC domiciliaria entre 2005 y 2015 mediante la búsqueda en MEDLINE (®), Embase, PsycINFO, Web of Science y Cochrane Database. MÉTODO: Los revisores seleccionaron de forma independiente títulos y resúmenes de elegibilidad. Se extrajeron datos relevantes, incluyendo BCT, de los estudios incluidos. Un meta-análisis estudió el cambio del factor de riesgo en los programas basados en el hogar y comparadores. RESULTADOS: De 2448 estudios identificados, 11 de buena calidad metodológica (10 en post-miocardio infarto, uno en insuficiencia cardíaca, 1907 pacientes) se incluyeron. Estos informaron el uso de 20 diferentes BCTs. El apoyo social (no especificado) se utilizó en todos los estudios y el establecimiento de metas (comportamiento) en 10. De los 11 estudios, 10 informaron eficacia en la reducción de los factores de riesgo de ECV, pero un estudio no mostró ninguna mejora en comparación con la atención habitual. Este estudio difiere de los programas efectivos en que no incluye los BCT que tienen instrucciones sobre cómo realizar el comportamiento y el monitoreo, o una fuente creíble. CONCLUSIÓN: El apoyo social y la fijación de metas se utilizaron con frecuencia BCT en los programas de CR en el hogar, con los BCT relacionados con el monitoreo, la instrucción sobre cómo realizar el comportamiento y la fuente creíble de ser incluidos en programas efectivos. Otros ensayos robustos son necesarios para determinar el valor relativo de diferentes BCTs dentro de los programas de RC.
Coronary heart disease (CHD) is the most common cause of death globally. However, with falling CHD mortality rates, an increasing number of people living with CHD may need support to manage their symptoms and prognosis. Exercise-based cardiac rehabilitation (CR) aims to improve the health and outcomes of people with CHD. This is an update of a Cochrane Review previously published in 2016.
OBJECTIVES:
To assess the clinical effectiveness and cost-effectiveness of exercise-based CR (exercise training alone or in combination with psychosocial or educational interventions) compared with 'no exercise' control, on mortality, morbidity and health-related quality of life (HRQoL) in people with CHD.
SEARCH METHODS:
We updated searches from the previous Cochrane Review, by searching CENTRAL, MEDLINE, Embase, and two other databases in September 2020. We also searched two clinical trials registers in June 2021.
SELECTION CRITERIA:
We included randomised controlled trials (RCTs) of exercise-based interventions with at least six months' follow-up, compared with 'no exercise' control. The study population comprised adult men and women who have had a myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI), or have angina pectoris, or coronary artery disease.
DATA COLLECTION AND ANALYSIS:
We screened all identified references, extracted data and assessed risk of bias according to Cochrane methods. We stratified meta-analysis by duration of follow-up: short-term (6 to 12 months); medium-term (> 12 to 36 months); and long-term ( > 3 years), and used meta-regression to explore potential treatment effect modifiers. We used GRADE for primary outcomes at 6 to 12 months (the most common follow-up time point).
MAIN RESULTS:
This review included 85 trials which randomised 23,430 people with CHD. This latest update identified 22 new trials (7795 participants). The population included predominantly post-MI and post-revascularisation patients, with a mean age ranging from 47 to 77 years. In the last decade, the median percentage of women with CHD has increased from 11% to 17%, but females still account for a similarly small percentage of participants recruited overall ( < 15%). Twenty-one of the included trials were performed in low- and middle-income countries (LMICs). Overall trial reporting was poor, although there was evidence of an improvement in quality over the last decade. The median longest follow-up time was 12 months (range 6 months to 19 years). At short-term follow-up (6 to 12 months), exercise-based CR likely results in a slight reduction in all-cause mortality (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.73 to 1.04; 25 trials; moderate certainty evidence), a large reduction in MI (RR 0.72, 95% CI 0.55 to 0.93; 22 trials; number needed to treat for an additional beneficial outcome (NNTB) 75, 95% CI 47 to 298; high certainty evidence), and a large reduction in all-cause hospitalisation (RR 0.58, 95% CI 0.43 to 0.77; 14 trials; NNTB 12, 95% CI 9 to 21; moderate certainty evidence). Exercise-based CR likely results in little to no difference in risk of cardiovascular mortality (RR 0.88, 95% CI 0.68 to 1.14; 15 trials; moderate certainty evidence), CABG (RR 0.99, 95% CI 0.78 to 1.27; 20 trials; high certainty evidence), and PCI (RR 0.86, 95% CI 0.63 to 1.19; 13 trials; moderate certainty evidence) up to 12 months' follow-up. We are uncertain about the effects of exercise-based CR on cardiovascular hospitalisation, with a wide confidence interval including considerable benefit as well as harm (RR 0.80, 95% CI 0.41 to 1.59; low certainty evidence). There was evidence of substantial heterogeneity across trials for cardiovascular hospitalisations (I2 = 53%), and of small study bias for all-cause hospitalisation, but not for all other outcomes. At medium-term follow-up, although there may be little to no difference in all-cause mortality (RR 0.90, 95% CI 0.80 to 1.02; 15 trials), MI (RR 1.07, 95% CI 0.91 to 1.27; 12 trials), PCI (RR 0.96, 95% CI 0.69 to 1.35; 6 trials), CABG (RR 0.97, 95% CI 0.77 to 1.23; 9 trials), and all-cause hospitalisation (RR 0.92, 95% CI 0.82 to 1.03; 9 trials), a large reduction in cardiovascular mortality was found (RR 0.77, 95% CI 0.63 to 0.93; 5 trials). Evidence is uncertain for difference in risk of cardiovascular hospitalisation (RR 0.92, 95% CI 0.76 to 1.12; 3 trials). At long-term follow-up, although there may be little to no difference in all-cause mortality (RR 0.91, 95% CI 0.75 to 1.10), exercise-based CR may result in a large reduction in cardiovascular mortality (RR 0.58, 95% CI 0.43 to 0.78; 8 trials) and MI (RR 0.67, 95% CI 0.50 to 0.90; 10 trials). Evidence is uncertain for CABG (RR 0.66, 95% CI 0.34 to 1.27; 4 trials), and PCI (RR 0.76, 95% CI 0.48 to 1.20; 3 trials). Meta-regression showed benefits in outcomes were independent of CHD case mix, type of CR, exercise dose, follow-up length, publication year, CR setting, study location, sample size or risk of bias. There was evidence that exercise-based CR may slightly increase HRQoL across several subscales (SF-36 mental component, physical functioning, physical performance, general health, vitality, social functioning and mental health scores) up to 12 months' follow-up; however, these may not be clinically important differences. The eight trial-based economic evaluation studies showed exercise-based CR to be a potentially cost-effective use of resources in terms of gain in quality-adjusted life years (QALYs).
AUTHORS' CONCLUSIONS:
This updated Cochrane Review supports the conclusions of the previous version, that exercise-based CR provides important benefits to people with CHD, including reduced risk of MI, a likely small reduction in all-cause mortality, and a large reduction in all-cause hospitalisation, along with associated healthcare costs, and improved HRQoL up to 12 months' follow-up. Over longer-term follow-up, benefits may include reductions in cardiovascular mortality and MI. In the last decade, trials were more likely to include females, and be undertaken in LMICs, increasing the generalisability of findings. Well-designed, adequately-reported RCTs of CR in people with CHD more representative of usual clinical practice are still needed. Trials should explicitly report clinical outcomes, including mortality and hospital admissions, and include validated HRQoL outcome measures, especially over longer-term follow-up, and assess costs and cost-effectiveness.
