Development of a core outcome set for cardiac rehabilitation in patients with myocardial infarction: a study protocol.

INTRODUCTION: Heterogeneous outcome reporting is common in clinical trials focused on cardiac rehabilitation for myocardial infarction (MI); this practice often results in the exclusion of data from clinical trials in systematic reviews. Developing a core outcome set (COS) may solve this problem. METHODS AND ANALYSIS: We will first identify a preliminary list of outcomes through a systematic review. Next, we will conduct semistructured interviews with patients to explore additional potential outcomes deemed important by patients. Then, we will engage various stakeholders such as clinicians, researchers and methodologists in two Delphi survey tends to refine and prioritise the identified outcomes. Subsequently, we will gather insights directly from patients with MI by administering plain language patient surveys; patients will be involved in questionnaire development. Finally, we will hold two face-to-face consensus meetings for patients and other stakeholders to develop the final COS for cardiac rehabilitation in MI. ETHICS AND DISSEMINATION: The Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine approved this study (2022DZMEC-349). The final COS will be published in a peer-reviewed journal and disseminated in conferences. TRIAL REGISTRATION: We registered this study in the Core Outcome Measures in Effectiveness Trials Initiative (COMET) platform. REGISTRATION NUMBER: 1725 (http://www.comet-initiative.org/studies/details/1725).

The Rehabilitation Efficacy of the Novel Metronomic Breathing Technique for Gerontic Patients After Percutaneous Coronary Intervention for Acute Myocardial Infarction-A Pilot Study.

Background: The respiratory rehabilitation technique is a crucial component of early cardiac recovery in geriatric patients with acute myocardial infarction (AMI). This study primarily investigated the effectiveness of a novel respiratory rehabilitation technique, metronomic breathing (MB), on geriatric patients after percutaneous coronary intervention for AMI and compliance with home-based rehabilitation compared to traditional respiratory rehabilitation. Methods: From June 2022 to March 2023, 75 acute myocardial infarction (AMI) patients admitted to the Shanghai Tenth People's Hospital Cardiovascular Department were consecutively enrolled. Ultimately, 46 patients completed the follow-up in this study-26 in the MB group and 20 in the control group-who underwent the novel MB technique and conventional abdominal breathing training. The primary endpoint of the study was left ventricular function measured by noninvasive hemodynamics three months after discharge. The secondary endpoints were compliance and quality of life after three months of home rehabilitation. Results: After the intervention, several cardiac functional parameters (SV, SVI, CO, CI, LCW, and LCWI), myocardial contractility parameters (VI), and systemic vascular resistance parameters (SVR and SVRI) were significantly greater in the MB group than in the preintervention group (P < 0.05). Furthermore, post-treatment, the MB group exhibited greater SV, SVI, CO, CI, and VI; lower SVR, SVRI, and SBP; and a lower readmission rate three months later than did the control group. The SF-36 scores after three months of MB intervention, PE, BP, GH, VT, SF, RE, and MH, were all significantly greater than those before treatment (P < 0.05). Moreover, the MB group displayed greater compliance with home-based cardiac rehabilitation (P < 0.05). Conclusion: Compared to conventional respiratory rehabilitation training methods, short-term metronomic respiratory therapy is more effective for reducing systemic vascular resistance, enhancing left ventricular ejection function, enhancing quality of life, and increasing home-based rehabilitation compliance in geriatric patients following AMI with PCI.

Effects of different early cardiac rehabilitation exercise treatments on the prognosis of acute myocardial infarction patients receiving percutaneous coronary intervention.

OBJECTIVES: Exercise rehabilitation is the core of Cardiac Rehabilitation (CR) and will improve the prognosis of patients receiving Percutaneous Coronary Intervention (PCI surgery). The current study retrospectively analyzed the effects of different exercise-based CR strategies on the prognosis of AMI patients receiving PCI treatment. METHODS: Clinicopathological information from 127 patients was collected and divided into different groups based on the exercise-based CR received, including Continuous Resistance Exercise (COR), Continuous Aerobic Exercise (COA), Interval Resistance Exercise (IVR), Interval Aerobic Exercise (IVA), Inspiratory Muscle Exercises (ITM), and Control. The differences regarding cardio-pulmonary function, hemodynamics, and life quality were analyzed against different CR strategies. RESULTS: All the exercise-based CR strategies showed improving effects compared with patients in the Control group regarding cardio-pulmonary parameters, with IVR showing the strongest improving effects (IVR > ITM > COR > IVA > COA) (p < 0.05) at the first recoding point. However, the improving effects of exercise-based CR declined with time. Regarding the effects on hemodynamics parameters, the improving effects of exercise-based CR were only observed regarding LVEF, and the effects of IVR were also the strongest (IVR > COR > ITM > COA > IVA) (p < 0.05). Similar improving effects were also observed for 6MWT and life quality (IVR showing the strongest improving effects) (p < 0.05), which all declined three months after the surgery. CONCLUSIONS: The current study showed that exercise-based CRs had better improving effects than the normal nursing strategy on the prognosis of AMI patients receiving PCI surgery.

Landscape therapy: rehabilitation potential in patients with post-infarction cardiosclerosis.

OBJECTIVE: Aim: To evaluate the rehabilitation potential, effectiveness and safety of landscape therapy in the complex rehabilitation treatment of patients with post-infarction cardiosclerosis (PC) complicated by chronic post-infarction cardiac aneurysm (CPCA) at the sanatorium stage. PATIENTS AND METHODS: Materials and Methods: We examined 62 patients with PC complicated by CPCA aged 38 to 65 years. Patients were randomized into two groups: the 1st group was undergoing the "Progressive gait" physical activity protocol in the city, and the 2nd group - in the rehabilitation department in a sanatorium. Survey, six-minute walk test, electrocardiography, echocardiography, coronary angiography were performed. RESULTS: Results: The average distance that 2nd group patients walked in 6 minutes increased from 301.00 ±17.00 to 467.00 ±32.00 m (p<0.05). Only in patients of 2nd group during 3 weeks of complex rehabilitation there was a decrease in body mass index from 23.70 ±1.60 to 18.90 ±1.50 and the diameter of the calf muscle significantly increased from 33.90 ±2.30 cm to 38.10 ±3.10 cm (p < 0.05). Ejection fraction in the 2nd group was 51.00 ±4.50% compared to the 1st group - 44.70 ±3.60% (p < 0.05), which was accompanied by a decrease in the functional class of heart failure in patients of the 2nd group. CONCLUSION: Conclusions: The rehabilitation potential of landscape therapy in the complex rehabilitation treatment of patients with complicated PC at the sanatorium stage is determined by a significant improvement in myocardial contractility and physical endurance of patients, and improving the quality of life.

The effect of audit and feedback and implementation support on guideline adherence and patient outcomes in cardiac rehabilitation: a study protocol for an open-label cluster-randomized effectiveness-implementation hybrid trial.

BACKGROUND: Providing secondary prevention through structured and comprehensive cardiac rehabilitation programmes to patients after a myocardial infarction (MI) reduces mortality and morbidity and improves health-related quality of life. Cardiac rehabilitation has the highest recommendation in current guidelines. While treatment target attainment rates at Swedish cardiac rehabilitation centres is among the highest in Europe, there are considerable differences in service delivery and variations in patient-level outcomes between centres. In this trial, we aim to study whether centre-level guideline adherence and patient-level outcomes across Swedish cardiac rehabilitation centres can be improved through a) regular audit and feedback of cardiac rehabilitation structure and processes through a national quality registry and b) supporting cardiac rehabilitation centres in implementing guidelines on secondary prevention. Furthermore, we aim to evaluate the implementation process and costs. METHODS: The study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation. DISCUSSION: Optimizing cardiac rehabilitation centres' delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT05889416 . Registered 2023-03-23.

Application of intensive management of risk awareness combined with cardiac rehabilitation nursing in elderly patients with acute myocardial infarction and heart failure.

The aim of this study is to assess the impact of intensive risk awareness management along with cardiac rehabilitation nursing in elderly patients with acute myocardial infarction and heart failure. We selected 101 elderly patients with acute myocardial infarction and heart aging treated from January 2022 to March 2023. They were divided into control and observation groups based on hospitalization numbers. The control group (n = 50) received routine nursing, while the observation group (n = 51) received intensive risk awareness management and cardiac rehabilitation nursing. We compared medication possession ratio (MPR), cardiac function, self-care ability scale scores, quality-of-life, incidents, and satisfaction between the 2 groups. Before intervention, there was no significant difference in MPR values between the 2 groups (P > .05). After intervention, MPR values increased in both groups, with a greater increase in the observation group (P < .05). Cardiac function showed no significant difference before intervention (P > .05), but after intervention, the observation group had lower left ventricular end-systolic and diastolic diameters and higher left ventricular ejection fraction compared to the control group (P < .05). Self-care skills, health knowledge, self-responsibility, and self-concept scores improved in both groups after intervention, with higher scores in the observation group (P < .05). The observation group had higher scores in various quality-of-life domains (P < .05). The total incidence of adverse events was lower in the observation group (5.88%) compared to the control group (20.00%) (P < .05). Patient satisfaction was significantly higher in the observation group (96.08%) than in the control group (84.00%) (P < .05). Intensive risk awareness management combined with cardiac rehabilitation nursing in elderly patients with acute myocardial infarction and heart aging can enhance medication compliance, improve quality-of-life, enhance self-care abilities, boost cardiac function, reduce incidents, and increase patient satisfaction.

Comprehensive Cardiac Rehabilitation Following Acute Myocardial Infarction Improves Clinical Outcomes Regardless of Exercise Capacity.

BACKGROUND: Reduced exercise capacity is a prognostic indicator of adverse outcomes in patients with acute myocardial infarction (AMI). However, few studies have evaluated the effectiveness of comprehensive cardiac rehabilitation (CR) in this population. This study aimed to clarify the efficacy of comprehensive CR in patients with AMI and reduced exercise capacity.Methods and Results: This cohort study included 610 patients with AMI who underwent percutaneous coronary intervention. Major adverse cardiovascular events (MACE) were compared between patients who participated in comprehensive outpatient CR for 150 days (CR group; n=430) and those who did not (non-CR group; n=180). During the mean (±SD) follow-up period of 6.1±4.0 years, the CR group exhibited a lower incidence of MACE (log-rank P=0.002). Multivariable analysis revealed that Killip classification, diuretics at discharge, and participation in comprehensive CR were independently associated with MACE. The CR group was further divided into 2 groups, namely reduced exercise capacity (% predicted peak V̇O2<80%; n=241) and preserved exercise capacity (≥80%; n=147), based on the initial cardiopulmonary exercise test. Despite distinct exercise capacities, the incidence of MACE was comparable and physical parameters improved similarly after comprehensive CR in both groups. CONCLUSIONS: Comprehensive CR in patients with AMI effectively reduced the incidence of MACE regardless of initial exercise capacity. Cardiologists should actively encourage patients with low exercise capacity to participate in comprehensive CR.

Cardiac Rehabilitation Using the Family-Centered Empowerment Model is Effective in Improving Long-term Mortality in Patients with Myocardial Infarction: A 10-year Follow-Up Randomized Clinical Trial.

INTRODUCTION: Cardiac rehabilitation (CR) play a critical role in reducing the risk of future cardiovascular events and enhancing the quality of life for individuals who have survived a heart attack. AIM: To assess the mortality rates and stability of the effects in myocardial infarction (MI) survivors after implementing a Family-Centered Empowerment Model (FCEM)-focused hybrid cardiac rehabilitation program. METHODS: This double-blind randomized controlled clinical trial, conducted at Shariati Hospital, an academic teaching hospital in Tehran, Iran (2012-2023), involved 70 MI patients and their families. Participants were randomly assigned to an FCEM intervention group or standard CR control group. The intervention commenced after the MI patient's safe discharge from the CCU and continued for the entire 10-year follow-up period. Various questionnaires were utilized to collect data on mortality rates and health-related quality of life (HRQoL). RESULTS: The 10-year follow-up period revealed lower mortality rates in the intervention group (5.7%, 11.4%, and 17.1% at 5, 7, and 10 years, respectively) compared to the control group (20%, 37.1%, and 48.9%). After adjusting for age, gender, and BMI, the control group had a four times higher mortality risk (HR: 4.346, 95% CI 1.671-7.307, P = 0.003). The FCEM-focused program demonstrated a significant and sustained positive impact on participants' quality of life for 48 months, with greater improvement compared to the control group. CONCLUSION: This study highlights the effectiveness of FCEM-based hybrid CR programs in enhancing long-term patient outcomes and reducing mortality rates among MI survivors. Further research is needed to explore the potential benefits in larger samples and diverse populations. TRIAL REGISTRATION: This study (Identifier: NCT02402582) was registered in the ClinicalTrials.gov on 03/30/2015.

The effect of personalized mobile health (mHealth) in cardiac rehabilitation for discharged elderly patients after acute myocardial infarction on their inner strength and resilience.

INTRODUCTION: Given the importance of promoting self-care and quality of life for discharged elderly patients after acute Myocardial Infarction(MI), It is necessitated we conduct interventions to promote these items. This study was conducted to determine the effect of mHealth-Cardiac rehabilitation (CR) on the inner Strength and resilience of elderly patients with MI after discharge from the hospital. METHODS: The present study was a randomized controlled trial that was conducted on 56 Elderly patients with myocardial infarction were discharged from the heart departments. In the intervention group after the patient's discharge, the patients were contacted twice a week for one month and the necessary training and support were given online. To gather data, the Mini-Mental State Examination (MMSE), the demographic and clinical characteristics questionnaire, the inner strength scale (ISS), and the Connor-Davidson Resilience Scale (CD-RISC) were completed pre- and post-intervention. The data analysis was done by SPSS16. RESULTS: This study showed the mean resilience and inner strength scores before and after the intervention in the control group had no statistically significant difference(P˃0.05). There was a significant increase in the mean resilience and inner strength scores in the intervention group after the intervention (P ≤ 0.001). CONCLUSION: The results of this study showed that mHealth as a kind of telenursing nursing has a significant effect on both variables of inner strength and resilience of post-discharge elderly patients after acute myocardial infarction. This means that using mHealth for these patients could increase the inner strength and resilience of the elderly discharged after myocardial infarction. Therefore, through using this method, elderly patients' self-care ability and quality of life could be increased.

Rationale and Design of the mTECH-Rehab Randomized Controlled Trial: Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Health.

BACKGROUND: Cardiac rehabilitation (CR) is an evidence-based, guideline-recommended intervention for patients recovering from a cardiac event, surgery or procedure that improves morbidity, mortality, and functional status. CR is traditionally provided in-center, which limits access and engagement, most notably among underrepresented racial and ethnic groups due to barriers including cost, scheduling, and transportation access. This study is designed to evaluate the Corrie Hybrid CR, a technology-based, multicomponent health equity-focused intervention as an alternative to traditional in-center CR among patients recovering from a cardiac event, surgery, or procedure compared with usual care alone. METHODS: The mTECH-Rehab (Impact of a Mobile Technology Enabled Corrie CR Program) trial will randomize 200 patients who either have diagnosis of myocardial infarction or who undergo coronary artery bypass grafting surgery, percutaneous coronary intervention, heart valve repair, or replacement presenting to 4 hospitals in a large academic health system in Maryland, United States, to the Corrie Hybrid CR program combined with usual care CR (intervention group) or usual care CR alone (control group) in a parallel arm, randomized controlled trial. The Corrie Hybrid CR program leverages 5 components: (1) a patient-facing mobile application that encourages behavior change, patient empowerment, and engagement with guideline-directed therapy; (2) Food and Drug Administration-approved smart devices that collect health metrics; (3) 2 upfront in-center CR sessions to facilitate personalization, self-efficacy, and evaluation for the safety of home exercise, followed by a combination of in-center and home-based sessions per participant preference; (4) a clinician dashboard to track health data; and (5) weekly virtual coaching sessions delivered over 12 weeks for education, encouragement, and risk factor modification. The primary outcome is the mean difference between the intervention versus control groups in distance walked on the 6-minute walk test (ie, functional capacity) at 12 weeks post randomization. Key secondary and exploratory outcomes include improvement in a composite cardiovascular health metric, CR engagement, quality of life, health factors (including low-density lipoprotein-cholesterol, hemoglobin A1c, weight, diet, smoking cessation, blood pressure), and psychosocial factors. Approval for the study was granted by the local institutional review board. Results of the trial will be published once data collection and analysis have been completed. CONCLUSIONS: The Corrie Hybrid CR program has the potential to improve functional status, cardiovascular health, and CR engagement and advance equity in access to cardiac rehabilitation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05238103.

Effect of maximal-intensity and high-intensity interval training on exercise capacity and quality of life in patients with acute myocardial infarction: a randomized controlled trial.

BACKGROUND: An increase in V̇O2max is important for acute myocardial infarction morbidity, and recurrence rate and intensity have been suggested as important factors in improving V̇O2max. AIM: The aim of this study was to compare the effects of maximal-intensity interval training (MIIT) and high-intensity interval training (HIIT) on exercise capacity and health-related Quality of Life (HRQoL) in patients with acute myocardial infarction (MI) at low and moderate cardiac risk in cardiac rehabilitation (CR). This study secondarily aimed to compare the effects of hospital-based phase II CR and usual care. DESIGN: This study is a randomized controlled trial. SETTING: Outpatient Rehabilitation Setting. POPULATION: Fifty-nine patients with acute MI were randomly assigned to the MIIT (N.=30) or HIIT (N.=29) group, and 32 to the usual care group. METHODS: Twice a week, an intervention was conducted for nine weeks in all groups. The maximum oxygen intake (V̇O2max) and MacNew Heart Disease HRQoL were evaluated before and after intervention. RESULTS: A significant interaction was observed between time and group for V̇O2max (P<0.001). The MIIT group showed greater improvement than those exhibited by the HIIT and usual care groups (P<0.05). Similarly, a significant time and group interaction was observed on the MacNew Global, Physical, and Emotional scales (P<0.05), but not on the social scale (P>0.05). CONCLUSIONS: Compared to HIIT and usual care, MIIT significantly increased the V̇O2max and was as safe as HIIT in patients with acute MI with low and moderate cardiac risk in CR. Additionally, MIIT and HIIT were superior to usual care in terms of improving the HRQoL. CLINICAL REHABILITATION IMPACT: Our results suggest that increased intensity in phase II CR could result in better outcomes in terms of V̇O2max increment in patients with acute MI and low and moderate cardiac risk in CR.

Cohort profile: Data standards for cardiac rehabilitation structure and processes for the SWEDEHEART cardiac rehabilitation (SWEDEHEART-CR) registry.

Data standards for quality registries should be evidence-based and follow guideline recommendations. To optimally monitor quality of care, not only patient-level variables, but also centre-level variables need to be included. Here we describe the development of variables to audit the structure and processes in cardiac rehabilitation for patients after myocardial infarction, and the resulting data standards to be implemented in the Swedish quality registry for cardiac disease, SWEDEHEART. The methodology used for the development of international clinical data standards for the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) was followed. Based on national guidelines for secondary prevention, candidate variables were prepared, after which a multiprofessional expert group on cardiac rehabilitation selected key variables and assured face validity. An external reference group had the role of peer reviewing, ascertaining content validity and test-retest reliability. The process has resulted in 30 data standards to be introduced into the SWEDEHEART cardiac rehabilitation registry and administered on centre-level biannually. The data standards include measures of human resources, centre requirements and process-based metrics. Including registry variables which audit centre-level structure and processes is essential to improve benchmarking and standardize monitoring of quality of care, covering both services provided and patient outcomes.

Intensive nurse-led follow-up in primary care to improve self-management and compliance behaviour after myocardial infarction.

AIMS AND OBJECTIVES: To assess the effects of intensive follow-up by primary care nurses on cardiovascular disease self-management and compliance behaviours after myocardial infarction. BACKGROUND: Although cardiovascular disease prevention and cardiac rehabilitation take place in hospital settings, a nurse-led approach is necessary in primary care during the first few months after a myocardial infarction. Therefore, it is important to assess self-management of cardiovascular disease and levels of compliance with the prescribed diet, physical activity, and medication. DESIGN: The study used a multicentre, quasi-experimental, pre-post design without a control group. METHODS: Patients with acute coronary syndrome from 40 healthcare facilities were included in the study. A total of 212 patients participated in a programme including 11 interventions during the first 12-18 months after myocardial infarction. The following Nursing Outcomes Classification (NOC) outcomes were assessed at baseline and at the end of the intervention: Self-management: Cardiac Disease (1617) and Compliance Behaviour: Prescribed Diet (1622), Compliance Behaviour: Prescribed Activity (1632), and Compliance Behaviour: Prescribed Medication (1623). Marjory Gordon's functional health patterns and a self-care notebook were used in each intervention. Pre-post intervention means were compared using Student's t-tests for related samples. The results of the study are reported in compliance with the TREND Statement. RESULTS: A total of 132 patients completed the intervention. The indicators for each NOC outcome and the variations in scores before and after the intensive follow-up showed a statistically significant improvement (p-value = 0.000). Compliance Behaviour: Prescribed Diet (pre = 3.7; post = 4.1); Compliance Behaviour: Prescribed Activity (pre = 3.9; post = 4.3); Compliance Behaviour: Prescribed Medication (pre = 3.9; post = 4.7). CONCLUSION: Intensive, immediate follow-up after myocardial infarction improves compliance behaviours and self-management of heart disease. A combined self-care and family care approach should be encouraged to empower post-myocardial infarction patients. To facilitate patients' self-efficacy, the use of health education tools such as a cardiovascular self-care notebook can also be helpful. RELEVANCE TO CLINICAL PRACTICE: This study highlights the benefits of intensive, protocolised, comprehensive patient follow-up in primary care during the first few months after an acute myocardial infarction (AMI). Primary care nurses train patients in cardiovascular self-care. PATIENT OR PUBLIC CONTRIBUTION: Patients were not involved in either the design or the carrying out of the study. However, at the end of the study, they participated in an evaluation process about the utility of the research study and their satisfaction with it. This process was carried out using an ad hoc survey consisting of 10 questions assessing the nursing care and follow-up inputs that were received.

Comprehensive Cardiac Care: How Much Does It Cost?

The benefits of coordinating care between healthcare professionals and institutions are the main drivers behind reforms to the payment and delivery system for healthcare services. The purpose of this study was to analyse the costs incurred by the National Health Fund in Poland related to the comprehensive care model for patients after myocardial infarction (CCMI, in Polish: KOS-Zawal). METHODS: The analysis involved data from 1 October 2017 to 31 March 2020 for 263,619 patients who received treatment after a diagnosis of first or recurrent myocardial infarction as well as data for 26,457 patients treated during that period under the CCMI programme. RESULTS: The average costs of treating patients covered by the full scope of comprehensive care and cardiac rehabilitation under the programme (EUR 3113.74/person) were higher than the costs of treating patients outside of that programme (EUR 2238.08/person). At the same time, a survival analysis revealed a statistically significantly lower probability of death (p < 0.0001) in the group of patients covered by CCMI compared to the group not covered by the programme. CONCLUSIONS: The coordinated care programme introduced for patients after myocardial infarction is more expensive than the care for patients who do not participate in the programme. Patients covered by the programme were more often hospitalised, which might have been due to the good coordination between specialists and responses to sudden changes in patients' conditions.