Cardiac Rehabilitation Intervention Research Articles

Cardiac Rehabilitation versus Percutaneous Coronary Intervention for Stable Angina Pectoris: A Retrospective Study of Effects on Major Adverse Cardiovascular Events and Associated Healthcare Costs.

Cardiac Rehabilitation versus Percutaneous Coronary Intervention for Stable Angina Pectoris: A Retrospective Study of Effects on Major Adverse Cardiovascular Events and Associated Healthcare Costs.

Applying Exercise Capacity and Physical Activity as Single vs Composite Endpoints for Trials of Cardiac Rehabilitation Interventions: Rationale, Use-case, and a Blueprint Method for Sample Size Calculation

ObjectiveTo conceptualize a composite primary endpoint for parallel-group RCTs of exercise-based cardiac rehabilitation (CR) interventions and to explore its application and statistical efficiency. DesignWe conducted a statistical exploration of sample size requirements. We combined exercise capacity and physical activity for the composite endpoint (CE), both being directly related to reduced premature mortality in patients with cardiac diseases. Based on smallest detectable and minimal clinically important changes (change in exercise capacity of 15 W and change in physical activity of 10 min/day), the CE combines 2 dichotomous endpoints (achieved/not achieved). To examine statistical efficiency, we compared sample size requirements based on the CE to single endpoints using data from 2 completed CR trials. SettingCardiac rehabilitation phase III. ParticipantsPatients in cardiac rehabilitation. InterventionsNot applicable. Main Outcome Measure(s)Exercise capacity (Pmax assessed by incremental cycle ergometry) and physical activity (daily minutes of moderate to vigorous physical activity assessed by accelerometry). ResultsExpecting, for example, a 10% between-group difference and improvement in the clinical outcome, the CE would increase sample size by up to 21% or 61%, depending on the dataset. When expecting a 10% difference and designing an intervention with the aim of non-deterioration, the CE would allow to reduce the sample size by up to 55% or 70%. ConclusionsTrialists may consider the utility of the CE for future studies in exercise-based CR to reduce sample size requirements. However, perhaps surprisingly at first, the CE could also lead to an increased sample size needed, depending on the observed baseline proportions in the trial population and the aim of the intervention.

The role of cardiac rehabilitation in patients with atrial fibrillation and heart failure

Abstract: This review investigates the role and effectiveness of cardiac rehabilitation in individuals diagnosed with atrial fibrillation and heart failure. A comprehensive analysis of existing literature, clinical trials, and observational studies was conducted to assess the outcomes associated with cardiac rehabilitation interventions in this specific patient population. The complex and bidirec-tional relationship between atrial fibrillation and heart failure underscores the importance of a patient-centered approach that integrates medical, lifestyle, and rehabilitative interventions for optimal care and outcomes. Results suggest improved functional capacity, enhanced quality of life, and potential favorable cardiovascular outcomes. The review brings new insights to the existing literature, emphasizing the importance of personalized cardiac rehabilitation strategies in opti-mizing the overall well-being of these patients.

Understanding adaptive tasks in cardiac rehabilitation among patients with acute myocardial infarction: a qualitative study

Background While Cardiac Rehabilitation (CR) programs have shown effectiveness in improving cardiac outcomes, there is limited understanding of how patients perceive and adapt to these interventions. Furthermore, alternative modes of delivering CR that have received positive evaluations from participants remain underexplored, yet they have the potential to enhance CR uptake. Objectives To explore the patient experience in CR programmes following Acute Myocardial Infarction (AMI) and describe their adaptive processing. Patients and Methods This qualitative study was conducted at a nationally certified centre in China between July 2021 and September 2022, encompassing three stages: in-hospital, centre-based, and home-based CR programs. Purposive sampling was used to select eligible AMI patients for in-depth semi-structured interviews. The interview outline and analytical framework were aligned with the key concepts derived from the middle-range theory of adaptation to chronic illness and the normalization process theory. The findings were reported following the Consolidated Criteria for Reporting Qualitative Research checklist. Results Forty AMI patients were recruited. Four main themes describing the process of AMI patients normalizing CR intervention were identified, including (1) experiencing CR service driving by role’s responsibilities, (2) engaging in collaborative relationship based on interpersonal trust, (3) exploring a personalized rehabilitation plan by complex integration, and (4) expecting a promised outcome to shape decision-making. Conclusion Integrated care interventions for AMI patients could benefit from a collaborative co-designed approach to ensure that CR interventions are normalized and fit into patients’ daily lives. Organizational-level CR services should align with the rehabilitation needs and expectations of patients.

Safety and long-term outcomes of remote cardiac rehabilitation in coronary heart disease patients: A systematic review.

To systematically review the safety and the long-term mortality and morbidity risk-rates of the remotely-delivered cardiac rehabilitation (RDCR) interventions in coronary heart disease (CHD) patients. The protocol was registered in the International Prospective Register of Systematic Reviews (CRD42023455471). Five databases (Pubmed, Scopus, Cochrane Central Register of Controlled Trials in the Cochrane Library, Cinahl and Web of Science) were reviewed from January 2012 up to August 2023. Inclusion criteria were: (a) randomized controlled trials, (b) RDCR implementation of at least 12 weeks duration, (c) assessment of safety, rates of serious adverse events (SAEs) and re-hospitalization incidences at endpoints more than 6 months. Three reviewers independently performed data extraction and assessed the risk of bias using the Cochrane Risk of Bias tool. 14 studies were identified involving 2012 participants and a range of RDCR duration between 3 months to 1 year. The incidence rate of exercise-related SAEs was estimated at 1 per 53,770 patient-hours of RDCR exercise. A non-statistically significant reduction in the re-hospitalization rates and the days lost due to hospitalization was noticed in the RDCR groups. There were no exercise-related deaths. The overall study quality was of low risk. RDCR can act as a safe alternative delivery mode of cardiac rehabilitation (CR). The low long-term rates of reported SAEs and re-hospitalization incidences of the RDCR could enhance the uptake rates of CR interventions. However, further investigation is needed in larger populations and longer assessment points.

Examining the effectiveness of home-based cardiac rehabilitation programs for heart failure patients with reduced ejection fraction: a critical review

BackgroundHeart failure (HF) is the most common cardiovascular reason for hospital admission, particularly among patients older than 60 years old. Heart failure with reduced ejection fraction (HFrEF) comprises approximately 50% of all heart failure cases. Home-based cardiac rehabilitation (HBCR) is an alternative option to enhance the participation rate in cardiac rehabilitation (CR) interventions for patients who are not able to attend center-based cardiac rehabilitation (CBCR). The purpose of this review is to clarify the extent to which present studies of HBCR align with the core components defined by both the European Society of Cardiology (ESC) and the British Association for Cardiac Prevention and Rehabilitation (BACPR).MethodsA critical review was conducted through four databases, MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews, to identify randomized controlled trials up until June 2022. We scrutinized the commonalities between BACPR and ESC and developed a list of standards. The risk of bias was assessed using the RoB 2 tool.ResultsAmong the 87 papers selected for full-text screening, 11 studies met the inclusion criteria. Six papers possessed a high proportion of fidelity to essential standards, four studies had a medium alliance, and one intervention had a low level of alliance.ConclusionOverall, the majority of included studies had medium to high alignment with standards and core components. However, a need for more attention to long-term strategy as an important standard is revealed. Rapid identification and initial assessment are the most met standards; however, lifestyle risk factor management and long-term outcomes were recognized as the least met standards.

Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocol

BackgroundPatients with heart failure with preserved ejection fraction (HFpEF) have a low functional status, which in turn is a risk factor for hospital admission and an important predictor of survival in HFpEF. HFpFE is a heterogeneous syndrome and recent studies have suggested an important role for careful, pathophysiological-based phenotyping to improve patient characterization. Cardiac rehabilitation has proven to be a useful tool in the framework of secondary prevention in patients with HFpEF. Facilitating decision-making and implementing cardiac rehabilitation programs is a challenge in public health systems for HFpEF management. The FUNNEL + study proposes to evaluate the efficacy of an exercise and education-based cardiac rehabilitation program on biomechanical, physiological, and imaging biomarkers in patients with HFpEF.MethodsA randomised crossover clinical trial is presented among people older than 70 years with a diagnosis of HFpEF. The experimental group will receive a cardiac rehabilitation intervention for 12 weeks. Participants in the control group will receive one educational session per week for 12 weeks on HFpEF complications, functional decline, and healthy lifestyle habits. VO2peak is the primary outcome. Biomechanical, imaging and physiological biomarkers will be assessed as secondary outcomes. Outcomes will be assessed at baseline, 12 weeks, and 24 weeks.DiscussionIdentifying objective functional parameters indicative of HFpEF and the subsequent development of functional level stratification based on functional impairment ("biomechanical phenotypes") may help clinicians identify cardiac rehabilitation responders and non-responders and make future clinical decisions. In this way, future pharmacological and non-pharmacological interventions, such as exercise, could be improved and tailored to improve quality of life and prognosis and reducing patients' hospital readmissions, thereby reducing healthcare costs.Trial registrationNCT05393362 (Clinicaltrials.gov).

Home- versus centre-based EXercise InTervention in patients with Heart Failure (EXIT-HF trial): A pragmatic randomized controlled trial

IntroductionThe limited accessibility and the lack of adherence explain, in part, the low proportion of heart failure (HF) patients undergoing exercise-based cardiac rehabilitation (CR) programs. Home-based programs showed to be as effective and less costly than centre-based ones and might address those obstacles. Whether the evidence from international studies can be applied to our population is still unclear. ObjectivesTo compare the clinical and economic impact of a home-based versus centre-based CR intervention in HF patients. MethodsThis is a single-center, single-blind, parallel groups, non-inferiority pragmatic randomized control trial. Adult HF patients (n=120) will be randomized to either a centre-based or home-based CR program. In both groups’ patients will participate in a 12-week combined CR program with 2 sessions per week. Exercise training (ExT) protocol consists of a combination of endurance [(at 60%–80% of peak oxygen uptake (VO2peak)] and resistance training (elastic bands). Those allocated to the home-based program will start with 4–5 supervised ExT sessions to familiarize themselves with the training protocol and then will continue the remaining sessions at home. The primary endpoint is the change in VO2peak at the end of the 12-week program. Secondary outcomes include alterations in circulating biomarkers, physical fitness, physical activity, quality of life, diet, psychological wellbeing, dyspnea, and cost-effectiveness analyses. ResultsPatients are currently being recruited for the study. The study started in November 2019 and data collection is anticipated to be completed by December 2022. This is the first study in Portugal comparing the traditional CR program with a home-based program in HF patients. Our study results will better inform healthcare professionals who care for HF patients regarding CR.

Cardiac rehabilitation and caregivers challenges A scoping review

Abstract Funding Acknowledgements Type of funding sources: None. Objective Map the interventions directed to the caregiver of heart disease (HD)patients in cardiac rehabilitation programs (CRP) that promote their role and health. Methods Scoping Review guided by the Joanna Briggs Institute method. Two independent reviewers assessed articles for relevance and extracted and synthesized data. Inclusion criteria comprised articles published in English, Spanish and Portuguese since 1950. The following databases were searched: CINAHL Complete (Via EBSCO); Medline (via PubMed); Scopus, PEDro, e Repositórios Científicos de Acesso Aberto de Portugal (RCAAP). Results From 351 articles retrieved, ten were included in the review. Different interventions were identified directed to the caregiver of HD patients: educational interventions and lifestyle changes, physical exercise, psychological interventions/stress management, and a category "Other" with training interventions in basic life support, elaboration of guidelines/recommendations and training for the role of caregiver. Regarding the population, heart failure patient caregivers are the primary intervention targets, followed by caregivers of patients with ischemic disease and integrated into CRP. Regarding the context, there is a concern that the professional intervention with the caregivers should be mainly at home (home-based), using face-to-face and telehealth monitoring, often combined, with references also to the hospital context, primary health care and rehabilitation center. Conclusions and implications for the clinical practice: It was found that most of the identified cardiac rehabilitation interventions are aimed at the dyad HD patient and caregiver/family. Including specific interventions targeting caregivers improves the caregiver’s health and empowers him/her. Patients care planning should include interventions specifically aimed at them that result into health gains for caregivers and patients, aiming at the quality of care.

Interventions for Caregivers of Heart Disease Patients in Rehabilitation: Scoping Review.

The Joanna Briggs Institute method was used to guide this scoping review. Two independent reviewers assessed articles for relevance and extracted and synthesized data. Inclusion criteria comprised articles published in English, Spanish, and Portuguese since 1950. The following databases were searched: CINAHL Complete (Via EBSCO), Medline (via PubMed), Scopus, PEDro, and Repositórios Científicos de Acesso Aberto de Portugal (RCAAP). From 351 articles retrieved, 10 were included in the review. The interventions identified directed to the caregiver were: educational interventions and lifestyle changes; physical exercise; psychological interventions/stress management; and a category "Other" with training interventions in basic life support, elaboration of guidelines/recommendations, and training for the role of caregiver. It was found that most of the related cardiac rehabilitation interventions are aimed at the dyad heart failure patient and their caregivers/family. Including specific interventions targeting caregivers improves the caregiver's health and empowers them. Patient care planning should include interventions specifically aimed at them that result in health gains for caregivers and patients, striving to improve the quality of care. This study was not registered.

An internet-based cardiac rehabilitation intervention for patients with coronary artery disease: a pilot feasibility analysis

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): The University of Hong Kong Background Cardiac rehabilitation is confined to those high-risk patients, such as those with acute myocardial infarction and heart failure. Most patients with coronary artery disease (CAD) are not eligible for this evidence-based therapy. Purpose This study aimed to examine the feasibility and preliminary effects of a mobile intervention, titled "internet-based CArdiac Rehabilitation Enhancement (i-CARE)", on self-care behaviors, functional status, health-related quality of life (HRQoL), blood pressure, waist-to-height ratio and cholesterol level in patients with CAD. Methods This mixed-methods study comprised a pilot randomized controlled trial (RCT) and a qualitative phase. Patients in the intervention group received a 12-week i-CARE intervention, consisting of a single face-to-face orientation session and a mobile app consisting of three key user interfaces, including a self-monitoring dashboard with personalized interface according to their own risk profile, an interactive e-library covering various CAD-related self-care dimensions and a chat room for the nurse to provide continuous coaching and facilitate behavioral changes. The control group received standard care. Results Fifty patients with CAD were randomly allocated to the intervention (n = 25) or control group (n = 25). The i-CARE intervention was feasible and acceptable to CAD patients. Participants gave excellent ratings in the satisfaction survey. The i-Care group showed greater improvements in self-care behaviors (β = 6.213, 95%CI: 1.924 – 12.236, p = 0.016), HRQoL (β = 6.132, 95%CI: 1.276 – 15.237, p = 0.032) and functional status (β = 2.584, 95%CI: 1.050 – 7.226, p = 0.039) than the standard care group at the immediate post-intervention. No significant between-group changes in blood pressure, cholesterol and waist-to-height ratio were detected. The average number of logins to the app by the intervention group was 92.84 (21.45) and 84% of them accessed all modules available in the app. A total of 4,987 hits to the exercise videos were recorded during the intervention period. Most of the participants (88%) actively initiated a discussion or responded in the chat room. The qualitative data converged with the quantitative data, indicating that the intervention was highly feasible and acceptable to CAD patients. Conclusion The i-Care intervention is feasible and acceptable to CAD patients. It improves patients’ self-care behaviors, HRQoL and functional status. A full-scale RCT is warranted to investigate the longer-term effects of this intervention.

How was remote technology accepted among cardiac rehabilitees in outpatient self-rehabilitation context?

The purpose of the article The purpose of this study was to investigate cardiac rehabilitees’ experiences with wrist-worn activity monitor (Fitbit Charge HR) and internet-based coaching software (Movendos m-coach) in outpatient rehabilitation to promote physical activity and a healthy lifestyle. Materials and methods A 12-month cardiac rehabilitation intervention consisted of three 5-day inpatient periods in a rehabilitation centre, between which participants (n = 32; age mean 62.3 years old (SD 6.3), men n = 24 (75%)) used an activity monitor and internet-based coaching software at home. Experiences with the use of technologies were measured at the end of the 12-month intervention with a questionnaire that was designed using the framework of the Technology Acceptance Model (Likert scale 1–7; 1 = strongly agree and 7 = strongly disagree). Data analysis was based on indicators describing the average experiences and Spearman’s correlation coefficient. Results Both technologies had positive acceptance (internet application mean: 3.2, 95% CI: 2.6–3.7; activity monitor mean 2.1, 95% CI: 1.7–2.5). Sociodemographic factors, physical activity, and familiarity with using technology in daily life were not correlated with technology acceptance of either technology. Conclusions Cardiac rehabilitees had positive acceptance on wrist worn activity monitor and internet-based coaching software, which suggests the use of these tools in outpatient cardiac rehabilitation. Trial Registration ISRCTN Registry, url: https://doi.org/10.1186/ISRCTN61225589, reg. number: ISRCTN61225589

Applying User-Centered Design and Implementation Science to the Early-Stage Development of a Telehealth-Enhanced Hybrid Cardiac Rehabilitation Program: Quality Improvement Study.

Cardiac rehabilitation (CR) is an evidence-based intervention that improves event-free survival in patients with cardiac conditions, yet <27% of all eligible patients use CR in the United States. CR is traditionally delivered in clinic-based settings where implementation barriers abound. Innovative nontraditional program designs and strategies are needed to support widespread CR uptake. This study aimed to demonstrate how user-centered design (UCD) and implementation science (IS) principles and methods can be integrated into the early-stage development of nontraditional CR interventions. As part of a NewYork-Presbyterian Hospital (NYPH) quality improvement initiative (March 2020-February 2022), we combined UCD and IS principles and methods to design a novel home- and clinic-based telehealth-enhanced hybrid CR (THCR) program. We co-designed this program with multilevel stakeholders using an iterative 3-step UCD process to identify user and contextual barriers and facilitators to CR uptake (using semistructured interviews and contextual inquiry [step 1]), design an intervention prototype that targets contextual and user factors and emulates the evidence-based practice (through design workshops and journey mapping [step 2]), and review and refine the prototype (according to real-world usability testing and feedback [step 3]). The UCD process was informed by the Theoretical Domains Framework and Consolidated Framework for Implementation Research. At step 1, we conducted semistructured interviews with 9 provider- and system-level stakeholders (female: n=6, 67%) at 3 geographically diverse academic medical centers, which revealed behavioral (eg, self-efficacy and knowledge) and contextual (eg, social distancing guidelines, physical space, staffing, and reimbursement) barriers to uptake; hybrid delivery was a key facilitator. Step 2 involved conducting 20 design workshops and 3 journey-mapping sessions with multidisciplinary NYPH stakeholders (eg, digital health team, CR clinicians, and creative director) where we identified key design elements (eg, mix of clinic- and home-based CR and synchronous remote patient monitoring), yielding an initial THCR prototype that leveraged NYPH's telehealth infrastructure. At step 3, we conducted usability testing with 2 CR clinicians (both female) administering home-based sessions to 3 CR patients (female: n=1, 33%), which revealed usability themes (eg, ease of using remote patient monitoring devices or a telehealth platform, technology disruptions, and confidence in using the telehealth platform to safely monitor patients) and design solutions (eg, onboarding sessions, safety surveys, and fully supervised remote sessions) to be included in the final THCR prototype. Combining UCD and IS methods while engaging multidisciplinary stakeholders in an iterative process yielded a theory-informed THCR program targeting user and contextual barriers to real-world CR implementation. We provide a detailed summary of the process and guidance for incorporating UCD and IS principles and methods into the early-stage development of a nontraditional CR intervention. The feasibility, acceptability, appropriateness, and usability of the final THCR prototype is being evaluated in an ongoing study.

Digital Technologies in Cardiac Rehabilitation: A Science Advisory From the American Heart Association.

Cardiac rehabilitation has strong evidence of benefit across many cardiovascular conditions but is underused. Even for those patients who participate in cardiac rehabilitation, there is the potential to better support them in improving behaviors known to promote optimal cardiovascular health and in sustaining those behaviors over time. Digital technology has the potential to address many of the challenges of traditional center-based cardiac rehabilitation and to augment care delivery. This American Heart Association science advisory was assembled to guide the development and implementation of digital cardiac rehabilitation interventions that can be translated effectively into clinical care, improve health outcomes, and promote health equity. This advisory thus describes the individual digital components that can be delivered in isolation or as part of a larger cardiac rehabilitation telehealth program and highlights challenges and future directions for digital technology generally and when used in cardiac rehabilitation specifically. It is also intended to provide guidance to researchers reporting digital interventions and clinicians implementing these interventions in practice and to advance a framework for equity-centered digital health in cardiac rehabilitation.

Te Kaahui Ora Māori Health Team Offering Whanau Ora and Secondary Prevention in Te Whatu Ora – Counties Manukau

Cardiac rehabilitation (CR) is an important evidence-based secondary prevention intervention following acute coronary syndrome (ACS). In this catchment, Māori uptake of CR is persistently low. A partnership with the Māori health team was introduced during the COVID pandemic to deliver a Te Kaahui Ora model of care. Using the ACS and CR database, 100 consecutive Māori patients—50 preintervention and 50 postintervention—were retrospectively audited. All patients were discharged alive after ACS with similar characteristics: 78% vs 72%, revascularised, 93% vs 94% discharged on standard ACS medications. Risk factors: smoking 53% vs 56%, mean SBP 145.4 vs 146.3, LDL >2, 86.3% vs 74%, BMI >30 67% vs 63%, and diabetes 34% vs 34%. The majority were male 64% vs 68% and mean age was 54 vs 58.6 years. Cardiac rehabilitation attendance declined 44% vs 28%; however, 96% in the intervention cohort received 20% home visits and 100% telephone support with often multiple contacts. The introduction of a wide-ranging intervention in Māori post-ACS patients resulted in a decrease in traditional CR attendance but also a significant increase in phase 1 and 2 contacts, and addressed a wide range of issues unlikely to be addressed in standard CR interventions.

Mindfulness-based stress reduction combined with early cardiac rehabilitation improves negative mood states and cardiac function in patients with acute myocardial infarction assisted with an intra-aortic balloon pump: a randomized controlled trial.

To investigate the clinical effects of mindfulness-based stress reduction (MBSR) intervention combined with early cardiac rehabilitation (CR) on patients with acute myocardial infarction (AMI) assisted with an intra-aortic balloon pump (IABP). A total of 100 AMI patients with IABP assistance due to hemodynamic instability at Wuhan Asia Heart Hospital were enrolled in the study. The participants were divided into two groups using the random number table method (n = 50 each group). Patients receiving routine CR were assigned to the CR control group, while patients receiving MBSR plus CR were assigned to the MBSR intervention group. The intervention was performed twice a day until the removal of the IABP (5-7 days). Each patient's level of anxiety/depression and negative mood state were evaluated before and after intervention using the self-rating anxiety scale (SAS), self-rating depression scale (SDS), and profiles of mood state scale (POMS). The results of the control and intervention groups were compared. IABP-related complications and left ventricular ejection fraction (LVEF), measured with echocardiography, were also assessed and compared between the two groups. The SAS, SDS, and POMS scores were lower in the MBSR intervention group than in the CR control group (P < 0.05). There were also less IABP-related complications in the MBSR intervention group. LVEF was significantly improved in both groups, but the degree of LVEF improvement was more significant in the MBSR intervention group than in the CR control group (P < 0.05). MBSR combined with early CR intervention can assist in alleviating anxiety, depression, and other negative mood states, reduce IABP-related complications, and further improve cardiac function in AMI patients with IABP assistance.

Exploring the usability of a chatbot-based conversational dietary assessment tool among cardiovascular patients

Abstract Funding Acknowledgements Type of funding sources: None. Background Dietary intervention in cardiac rehabilitation (CR) plays an integral role in health promotion and improving the quality of life for those with cardiovascular diseases (CVDs). Innovative techniques offer great potential to deliver cost-effective dietary modifications by providing dietary intake self-tracking and personalized advice. Nevertheless, the time-consuming inconvenience of manual food logging has led to the development of conversational agents that alleviate the tracking burden and promote self-reflection. However, the usability of nutrition chatbots among CVD patients has not yet been investigated in clinical practice. Purpose This study aimed to examine the usability of a chatbot-based dietary assessment tool among CVD patients in a prospective observational trial and discuss the preliminary results. Methods In the clinical trial, patients who are scheduled for or recently have undergone specific surgical procedures are selected for participation. Data collection starts one week before the intervention and continues until one year after discharge. Participants collect self-reported food intake data via the chatbot several times per day for a maximum of 4 non-consecutive days every other week. Quarterly assessments are scheduled to gather feedback on the use of the system. This paper focuses on the data collected in the first quarter of this trial. The usability was measured through chatbot usage and qualitative input through interviews. Results Participant recruitment started in December 2021. Thirteen out of sixteen participants (1 female and 15 males, mean_age=62.6) completed their first quarter of the trial. We included 1267 valid data entry points by evaluating the reported items and participants' self-perceived tracking accuracy. The average response rate is 87.83%, with the average self-perceived accuracy as 8.05. Although there's no significant difference in the time they spent reporting each meal (mean 110.79s, p&amp;gt;0.05), we observed a significant increase in the number of reported items for each meal (mean 3.79, p&amp;lt;0.05) and a significant decrease in time they spent reporting each item (mean 29.69s, p&amp;lt;0.01). Participants explained that while getting familiar with the chatbot, they found it increasingly easier to report more items if needed, and the self-reporting became less time-consuming. During the interview, the participants shared their enthusiasm about using the chatbot for food tracking and praised its simplicity and learnability. Meanwhile, they gave suggestions to improve the chatbot: 1) involving their partners when using the chatbot; 2) knowing the dietary behaviour of their peers; 3) receiving recognition with anonymous competitions. Conclusion The chatbot was found efficient to use with reasonable high learnability among participants. With insights into the usability issues and patients' expectations from the chatbot, we will conduct further research on developing personalized recommendations.

Physical activity and exercise capacity as composite versus single categorical endpoints for trials of exercise-based cardiac rehabilitation interventions: comparison of sample size requirements

Abstract Funding Acknowledgements Type of funding sources: None. Introduction A composite primary endpoint consists of two or more component endpoints, events or outcomes. If any one of these is observed, it is considered that the composite primary endpoint has been reached. A potential advantage of a composite over a single primary endpoint in a randomised controlled trial (RCT) is a reduction of the required sample size. Purpose The combined endpoint "major adverse cardiac events" (MACE) is well-established in cardiovascular research, but MACE is often unsuitable in trials of exercise-based cardiac rehabilitation interventions with short follow-up periods. We therefore explored the application of a composite primary endpoint incorporating exercise capacity and physical activity for parallel-group RCTs of exercise-based cardiac rehabilitation (CR) interventions. Methods Our composite endpoint combines two categorical (binary) single endpoints, i.e., exercise capacity (given as maximum mechanical power output of a graded exercise test) and physical activity. Thresholds for categorisation were defined on literature-based minimal clinically worthwhile changes and defined as an increase of 15 W or more for improving exercise capacity and an increase of 10 min/day or more for improving moderate to vigorous physical activity (MVPA). If the aim of an intervention is to avoid clinically meaningful deterioration (i.e., to achieve maintenance as opposed to improvement), the threshold is defined as deterioration in exercise capacity of less than 15 W and a reduction in MVPA of less than 10 min/day (figure 1). To illustrate the impact of a single versus a composite primary end point on sample size requirements, we used real-world data from two completed phase 3 CR trials ([1] and [2]). We applied the commonly used formula for estimating sample sizes to detect the difference between the probabilities of an event in two independent groups [3]. Results Sample size requirements for detecting a between-group difference of 5%, 10%, 15% and 20% under the different endpoint approaches are shown in table 1. If the aim of the intervention is to achieve improvement, the composite endpoint results in approximately equivalent sample size requirements to the single endpoint. If the aim of the intervention is to achieve maintenance, the composite endpoint results in markedly lower sample size requirements compared to the primary endpoint. Statistically, these differences are driven by the percentage of improvers or maintainers in the control group of the reference population. Conclusion The composite primary endpoint approach can be a useful alternative to the single primary endpoint in trials of exercise-based CR. Depending on the baseline probability, it may be possible to reduce the sample size requirement by applying a composite endpoint. In our examples, the composite endpoint results in smaller sample size requirements when the intervention aim is to avoid clinically meaningful deterioration.

Development of an integrated cardiac rehabilitation program to improve the adaptation level of patients after acute myocardial infarction.

Individual's adaptation following acute myocardial infarction (AMI) and low attendance of whole-course cardiac rehabilitation (CR) are significant issues. For optimal health post AMI, an integrated CR program aiming at individual's adaptive behaviors is imperative for improving the CR efficiency and patients' outcomes. This study aims to develop theory-guided interventions to increase CR attendance and adaptation level of patients post-AMI. This study was conducted in a tertiary hospital from July 2021 to September 2022 in Shanghai China. Guided by the theory of adaptation to chronic illness (ACI theory), the study followed the Intervention mapping (IM) framework to develop the interventions for CR program. Four phases included: (1) needs assessment of patients and facilitators using a cross-sectional study and semi-structured, in-depth interviews, (2) identification of implementation outcomes and performance objectives, (3) selection of theoretical methods to explain the mechanism of patients' adaptive behaviors and to use for behavior change, and (4) development of implementation protocol from the results of the previous phases. A total of 226 AMI patient-caregivers paired samples were eligible for the data analysis, 30 AMI patients participated in the qualitative inquiry, 16 experts in the CR field evaluated the implementation protocol, and 8 AMI patients commented on the practical interventions. Following the IM framework, an integrated cardiac rehabilitation program using mHealth strategies was developed for AMI patients to facilitate CR attendance and completion, to improve their adaptation level and health outcomes. Using the IM framework and ACI theory, an integrated CR program was developed to help guide the behavior change and improve adaptation among AMI patients. The preliminary findings suggest that further intervention in enhancing the combination of three-stage CR is required. A feasibility study will be conducted to assess the acceptability and effectiveness of this generated CR intervention.

Predictors of physical activity behavior change among patients with heart failure enrolled in home-based cardiac rehabilitation intervention

BackgroundPhysical activity behavior change is considered one of the most challenging lifestyle modifications in patients with heart failure. Even after participation in a cardiac rehabilitation program, most patients do not engage in the recommended level of physical activity. ObjectiveTo determine which baseline demographic, physical activity levels, psychological distress, and clinical variables predicted physical activity behavior change to increasing light-to-vigorous physical activity by 10,000 steps/day following participation in home-based cardiac rehabilitation intervention. MethodsA prospective design involving secondary analysis was used to analyze data obtained from 127 patients (mean, 61; range, 45–69 years) enrolled in and completed an 8-week home-based mobile health app intervention. The intervention was designed to encourage health behavior change with regard to decreasing sedentary behavior and increasing physical activities performed at light or greater intensities. ResultsNone of the participants accumulated 10,000 steps or more per day pre-intervention (mean, 1549; range, 318–4915 steps/day). Only 55 participants (43%) achieved an average daily step count of 10,000 or more at week 8 of the intervention (10,674 ± 263). The results of the logistic regression showed that higher pre-intervention physical activity levels and anxiety symptoms and lower depressive symptoms were associated with a higher likelihood of achieving physical activity behavior change (p < .003). ConclusionThese data highlight that determining pre-intervention physical activity levels and depressive symptoms can be the key to designing an effective home-based cardiac rehabilitation intervention in patients with heart failure.