Clinical Research Directory

Healthrelated Quality of Life and Experiences of a Heart Rehabilitation Programme After Care for Infective Endocarditis.

How does health develop after Infective endocarditis (IE)? Can the health of patients with IE be improved by participation in the physical exercise training within cardiac rehabilitation program? Participants will: * Answer digitally surveys on the perceived health for 4 times during 1 year * Participate in interviews on patient's experiences of health and rehabilitation 1 time before and 2 times after the training program during I year. * Be physically evaluated by a physiotherapist before and after the progam of physical exercise training within cardiac rehabilitation. * Do individual exercises in a group led by a physiotherapist 2 times weekly during 12 weeks.

Strength and Balance Integration in Maintenance Cardiac Rehabilitation for Older Adults

The goal of this cluster randomised clinical trial is to investigate the impact of adding strength and balance exercises into traditional aerobic-based Cardiac Rehabilitation Community/Maintenance classes on the functional fitness of older adults. The main questions it aims to answer are: 1. To explore participants' functional fitness changes, 2. Confidence in balance, 3. Concerns about falling compared to those participating in traditional aerobic-based cardiac rehabilitation only. 4. Understand the perceptions of participants regarding the addition of strength and balance into classes. 5. Understand the views of exercise professionals delivering the classes with additional strength and balance. Participants: 1. Will get their Functional fitness measured using the Functional Fitness MOT at baseline, and carry out questionnaires on their current physical activity levels, confidence in balance and concerns about falling. 2. The traditional aerobic-based cardiac rehabilitation classes (Clusters) will be randomised into Intervention Groups (additional strength and balance added) and usual care (Control Groups). 3. After 12 weeks, Functional Fitness and the questionnaires will be reassessed. 4. Two weeks after the 12-week follow-up, participants will be invited to an online focus group on Microsoft Teams to understand their perceptions of strength and balance. 5. Additionally, exercise Leaders will be invited to an interview on Microsoft Teams to discuss their views on strength and balance incorporation into maintenance cardiac rehabilitation classes.

Home-based Cardiac Rehabilitation With Spot-jogging

The first purpose of this study is to investigate the physiological changes of heart failure patients during cardiopulmonary exercise test with spot jogging and compare them with the standard stationary bike cardiopulmonary exercise test. The second one is to compare the effect between home-based cardiac rehabilitation using different step frequency and toe lift or not to adjust spot jogging intensity and outpatient center-based cardiac rehabilitation for heart failure patients.

OPTImizing CArdiac REhabilitation by REfining Sleep and STress

The primary objective of this project is to investigate the effectiveness and costs of integrating a behavioural program targeting sleep and stress (the RESST intervention) into cardiac rehabilitation (CR). In addition, the investigators will also study whether parameters regarding diversity (e.g., sex, ethnicity, socioeconomic position) are associated with intervention effectiveness. Furthermore, the investigators aim to explore the (bidirectional) relation between sleep and stress on the one hand, and other lifestyle components and health outcomes on the other hand.

Reducing Heart Failure Risk in Late-Life With Physical Activity

The goal of this clinical trial is to learn about the molecular pathways associated with the benefit of a regular exercise program in patients with high blood pressure and who don't already participate in regular exercise. The main question it aims to answer is to identify protein signatures associated with the benefits of a cardiac rehabilitation exercise program. The trial will enroll 42 participants, who will be randomized to a 12 week cardiac rehabilitation exercise program versus control arm and asked to participate in the following at the beginning and end of study: * Cardiopulmonary exercise test (CPET) * Echocardiogram * Physical function test * 6-minute walk test * Hand grip strength * Quality of life questionnaire * Blood draws Researchers will compare results between those who do and don't participate in the exercise program.

SMART to Optimize an Intervention to Maintain Health Improvements After Cardiac Rehabilitation

The study is sponsored by the National Heart, Lung, and Blood Institute, which is part of the National Institutes of Health. The study expects to enroll 400 subjects. The research team will recruit research participants that are finishing or will finish cardiac rehabilitation soon. Participants belong to one or more groups of people who are less often studied in cardiac rehabilitation research, may have less access to a formal cardiac rehabilitation maintenance program, or they may especially benefit from additional support after cardiac rehabilitation ends. The main purposes of this study are to evaluate which treatments work the best after cardiac rehabilitation, which order to deliver the treatments in, and which treatments are as minimally burdensome as possible while still working well. This study will make two comparisons (one comparison between a set of low-intensity interventions and another between a set of higher-intensity interventions) to determine which produces the best behavioral adherence immediately after Phase II (outpatient) cardiac rehabilitation

Application of Blood Flow Restriction Training in Cardiac Patients: CARDresfluj Study

1. Research Objective To describe and compare the effects on cardiovascular health, physical fitness, quality of life, oxidative stress, and sleep quality resulting from a conventional resistance training program versus a conventional resistance training program partially implemented with Blood Flow Restriction (BFR) in patients with Phase III cardiac disease. 2. Methodology, Expected Collaboration, and Duration Participants will be invited to undergo assessments for physical fitness, functional capacity, cardiological, hemodynamic, and biochemical control, as well as perceived quality of life and sleep quality, both prior to and following the intervention. Your collaboration in this study will consist of participating in a Phase III Cardiac Rehabilitation program, monitored by specialized personnel and supervised by a cardiologist. The intervention is based on a resistance training program supplemented with leg press and biceps curl exercises. These specific exercises will be performed using a blood flow restriction cuff. The intervention will be conducted twice weekly over a 10-week period, followed by a 2-months washout (rest) period. Subsequently, the 10-week intervention will be repeated; however, if the first phase was completed with the use of cuffs, the second phase will be conducted without them, and vice-versa (cross-over design).

Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

The purpose of this research is to see if taking part in a structured exercise plan that is designed to improve balance and muscle strength and one that can done at home helps to improve the ability to perform standard physical tasks, confidence in balance, and health-related quality-of-life

A Study to Compare the Effectiveness of Different High-intensity Interval Training Programs in Cardiac Rehabilitation

The purpose of the study is to examine the effect of two different high intensity interval training (HIIT) prescription approaches on improving fitness, heart function, and the ability of the body's muscles to receive oxygen.

Effectiveness of Home-Based Cardiac Rehabilitation

Statement of the Problem WHO stated that the average life expectancy has been recorded as 40 years among these in South Asian countries and 98 million people relate to Pakistan. Wang pointed out that the significant difference has been seen regarding provision of the health care facilities being provided in the rural and urban settings, called as health poverty in rural area as compared to urban areas. Therefore, accessibility of essential healthcare facilities such as experienced staff, vaccination and necessarily supply of medicines in rural population would be supporting reducing health poverty and will maintain equal and equitable opportunities. Andersen and Newman argued that there are main factors such as distance, time and travel costs that affect health accessibility for the poor people living in rural settings which are deprived of emergency care and common in developing economies. Cardiac Rehabilitation is a efficient, safe and affordable intervention that lowers overall health service financial burden. Additionally, CR are planned to optimize and restore physical, psychological, and social functioning by combining medical consultation, individualized exercise sessions, education, cardiac risk factor modification, and health counseling. CR is highly and mostly suggested as the key multicomponent and multi-dimensional intervention for the prevention of death by cardiac attacks, the lowering chances of hospital readmissions, and the enhancement of quality of life (QoL) of the people. Therefore, CR is one of the effective techniques to decrease the increasing number of cases and provide an efficient cardiac health intervention program with appropriate planning and organization. Despite the evidence of cost-effective rehabilitation program to optimize cardiac functioning at the hospital-based settings but the participation in cardiac rehabilitation, traditionally delivered in hospital outpatient departments or community, Despite the evidence of cost-effective rehabilitation program to optimize cardiac functioning at the hospital-based settings but the participation in cardiac rehabilitation, traditionally delivered in hospital outpatient departments or community centers, has remained low, with average participation rates \< 20% recorded in the United States and similarly in the Europe. Low participation has predominantly recorded mostly in few groups like women, elder population, ethnic minorities, and those living in rural settings or who are socioeconomically and financially resource constrained. Subsequently, these patients were contacted through calls for alternative options to center-based cardiac rehabilitation. Recommended interventions included cardiac rehabilitation at home transited by healthcare professionals with the support of telehealth technologies to maximize participation. Thus, the home-based cardiac rehabilitation program was recommended by the American Heart Association and the American College of Cardiology in 2019 through a scientific statement. Guidelines from NICE on chronic heart failure in the UK in 2018 said that "delivery of home-based rehabilitation may enhance the accessibility and participation. For changing behavior and improving quality of life, HBCR is an essential component of secondary prevention and an important alternative technique, for those patients who suffered a cardiac incident or experienced any other cardiac event. Hence, HBCR is one of the effective t strategies to reduce the higher number of cases. HBCR contains techniques for secondary prevention that facilitate cardiac patients to rebuild their functional cardiac capacity and decrease the magnitude of hospital visits and workload in emergency management in coronary critical areas. Most of the studies were done on cardiovascular disease and on the conventional approach of hospital-based cardiac rehabilitation, but rare literature in the context of Pakistan, especially Islamabad, was found on home-based cardiac rehabilitation to improve the quality of life and behavior of the patients. Thus, the study aims to evaluate the effectiveness of home-based cardiac rehabilitation to improve the quality of life and health behavior of patients with cardiovascular disease in low resource settings in Islamabad.

Exercise Prescription in Cardiac Rehabilitation Mediated by Autonomic Function

Cardiac rehabilitation (CR) is an essential secondary prevention component in the treatment of cardiovascular diseases and one of the most cost- effective clinical interventions. Exercise training (ET) in CR programs (CRP) has unequivocal benefits in the reduction of cardiovascular adverse events, by decreasing the overactivated sympathetic tone. This ET added value can be measured by variables that express autonomic control using indirect (standard) or direct (experimental) methodologies. Direct autonomic assessment (ex. Microneurography) is accurate but unusable in daily practice, whereas standard indirect autonomic assessment using clinical parameters is imprecise, resulting in underprescription to safeguard patient safety, with less benefit to the patients. In this project, we aim to apply Machine Learning models to a set of indirect and direct variables, to make a multivariate correlation analysis and so define a normalization factor for exercise prescription.

Construction and Application of an Intelligent Collaborative Cardiac Rehabilitation App for Middle-aged and Young Patients With Myocardial Infarction

This study is guided by the intervention mapping theory, combined with Fogg's behavior model and digital health technologies, focusing on the key rehabilitation obstacles and behavioral characteristics of young and middle-aged MI patients. It constructs a "smart + collaborative" out-of-hospital rehabilitation management model. This model, through systematic needs assessment and problem logical modeling \[11\], develops individualized rehabilitation paths covering multiple dimensions of intervention such as exercise, diet, medication, and psychological regulation. It relies on digital means such as mobile terminals, online education, behavior check-ins, real-time feedback, and remote follow-ups to achieve intelligent rehabilitation management. At the same time, it emphasizes the multi-disciplinary collaboration mechanism, integrating team members from cardiology, nursing, nutrition, rehabilitation, and psychology, forming a collaborative work system with information sharing, task complementarity, and consistent goals. Together, they promote the activation of patient motivation, improvement of behavioral ability, and improvement of rehabilitation compliance. The study will also verify its feasibility and initial effects in a real clinical environment, and evaluate its practical value in improving rehabilitation behaviors, promoting functional recovery, and enhancing quality of life. This study not only innovatively integrates intervention mapping and behavioral science models into the rehabilitation management of young and middle-aged MI patients in theory, filling the gap in existing rehabilitation models for this group, but also explores the path of digital rehabilitation intervention that can be promoted and replicated in grassroots clinical practice. The research results can provide practical basis for the construction of the smart rehabilitation service system under the background of "Healthy China 2030", and have important practical significance and social value.

Predictive Factors of Response to Phase II Cardiac Rehabilitation in Heart Failure With Reduced Ejection Fraction

Exercise intolerance, measured as peak oxygen consumption (VO₂peak) during exercise in patients with heart failure with reduced ejection fraction (HFrEF). Change in VO₂peak (ΔVO₂peak), which serves as a prognostic marker for HFrEF engaged in exercise based cardiac rehabilitation program (ExCR). Responders to ExCR generally show improved cardiac function but some patients with HFrEF do not respond to ExCR. VO₂peak depends on three major components of oxygen transport: Pulmonary (lungs), circulatory (heart and vessels) and skeletal muscle (oxygen utilization) functions. These physiological responses to ExCR may be influenced by epigenetic regulation, specifically the expression of circulating microRNAs (c-miRNAs). Linking non-invasive measurements and epigenetic markers could 1) identify which component of the oxygen transport chain is most impaired and 2) allow personalized interventions to maximize VO₂peak improvements. The primary objective of this stidy is to assess the association between changes in VO₂peak during exercise training and circulating microRNA expression (miR-146a, miR-191, miR-23a, miR-140, miR-1, miR-21, miR-133a, miR-17-5p, miR-3200-3p). The secondary objective is to examine the relationship between pulmonary, cardiovascular, and neuromuscular adaptations to exercise and circulating microRNA expression.

Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest

This study is a parallel group multicentre investigator-initiated clinical randomised controlled superiority trial that will include a total of 214 survivors of OHCA. Participants will to be randomized with a 1:1 allocation ratio to either a intervention consisting of a comprehensive initiated tailored rehabilitation intervention focusing on supporting RTW plus usual care compared to usual care alone.

Designing and Assessing a Women Only Cardiac Rehabilitation (CARE) Program

The purpose of this randomized controlled study is to investigate the effect(s) of a pilot women-only cardiac rehabilitation (CR) program. The study team will be testing the effectiveness, compliance and enjoyment of this women's only cardiac rehabilitation (CR) program by comparing outcomes to those randomized to receive Michigan Medicine's current CR program (standard care), which includes people of all genders. Study hypotheses: * Women randomized to women-specific CR programming will have superior attendance and completion rates compared to women attending mixed-sex CR programming. * Women randomized to women-specific CR programming will experience greater improvement in clinical outcomes in comparison to those in mixed-sex CR programming.

Sex Differences in Barriers and Participation in Physical Activity During and Following Cardiac Rehabilitation

The SPARC study will measure physical activity and functional fitness during cardiac rehabilitation, right after completion of cardiac rehabilitation, and 6 months later. This will help investigators learn if men and women maintain physical activity levels and functional fitness differently during and after they complete cardiac rehabilitation. Participants in this study will have three in-person study visits and may complete two qualitative interviews over a 10-month study period. The greatest risks during the study include physical discomfort, falling, and/or shortness of breath during the fitness testing.

The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance

Cardiac Rehabilitation is a lifestyle and exercise program for patients with heart disease. Cardiac Rehabilitation is strongly recommended in guidelines, but only 30% of eligible patients attend. New strategies are needed to help more patients attend cardiac rehabilitation. In this study, the investigators will see if using an $50 incentive, case management, text messages, and physical activity coaching combined into a single intervention will help more patients attend cardiac rehabilitation. In preparation for a larger trial, patients will also be randomly assigned to four different ways of seeking their permission to be in a research study. The investigators will see if these approaches affect how many people participate in the research project. The two main goals of this study is to understand: 1. If the consent approach type impacts participation rates in the research study 2. If the multi-component intervention (case management, financial incentives, text messages, and physical activity coaching) improves cardiac rehabilitation participation within 3 months.

Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty

Cardiac rehabilitation (CR) is a secondary prevention program for patients with cardiovascular disease (CVD). It is especially valuable as CVD increasingly occurs in combination with comorbidity, frailty, and complexities of care that predispose patients to functional decline, disability, and high costs. Still, few Veterans participate in CR, in part because of the difficult logistics to attend. Promising Practice home-based CR (HBCR) was developed to increase CR participation, but many Veterans remain too limited by comorbidity and frailty for participation. A Transition to CR (T2CR) intervention is a face-to-face program that fosters vital skills, education, insights, motivation, and patient-provider relationships conducive to successful HBCR thereafter. This study compares Veterans eligible for CR who are randomized to T2CR intervention versus usual care. Differences in functional capacity, HBCR participation, and healthy days at home are compared over one year. Patients' experiences and providers' perspectives of barriers and facilitators to T2CR are also compared.

Monitoring and Guidance of Physical Activity During the Maintenance Phase of Cardiac Rehabilitation: the Antwerp Activity Index

The goal of this clinical trial is to determine whether the AAI activity score can help cardiac rehabilitation patients adhere to physical activity guidelines after participating in an in-hospital cardiac rehabilitation program. The main questions it aims to answer are: 1. Does the AAI activity score have an impact on adherence to physical activity maintenance during phase 3 CR? 2. Does the AAI activity score predict changes in cardiorespiratory fitness? Researchers will compare participants who use the AAI activity score with those who do not to determine if there are differences in physical activity adherence. Participants will: * Wear a smartwatch to continuously measure heart rate for 4 months; * Perform an exercise stress test at the end of the study; * Fill in several questionnaires at the end of the study.

The Heart Health After Cardiac Treatment Study

The goal of this study is to determine whether participation in a tailored cardiac rehabilitation program delivered in a safety net setting, compared to usual care referral to an outside cardiac rehabilitation program, results in greater participation in cardiac rehabilitation.

Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery

The RECOVER study, titled Cardiac Rehabilitation Cohort at the Medicine Campus Davos for Exploration of Recovery, is a prospective, non-interventional, monocentric cohort study conducted at the Hochgebirgsklinik Davos. The study is sponsored by Medicine Campus Davos AG and the Kühne Foundation, with an estimated start date in July 2025 and planned completion by December 2034, with the possibility of extension. The principal investigator of the study is PD Dr. David Niederseer from Hochgebirgsklinik Davos, who also represents the study. The research team includes co-investigators such as Prof. Dr. Stefan Blankenberg and Prof. Dr. Andreas Ziegler from Cardio-CARE, Medicine Campus Davos, as well as Dr. Jan Vontobel from Hochgebirgsklinik Davos. The study will enroll patients referred to Hochgebirgsklinik Davos for cardiac rehabilitation who provide informed consent. Cardiac rehabilitation is an evidence-based therapy for patients with heart disease, including those who have undergone cardiac procedures or surgeries. The primary objectives are to evaluate baseline patient characteristics, rehabilitation strategies, predictors of recovery, and clinical outcomes during and after rehabilitation. To support this, a detailed database and biobank will be established to allow for comprehensive phenotyping, extensive clinical assessments, and long-term follow-up. RECOVER seeks to gain translational insights into how patient-specific factors - such as genetics, plasma, digital and clinical biomarkers, and comorbidities - influence long-term clinical outcomes. The goal is to identify modifiable risk factors to optimize individualized therapeutic approaches in cardiac rehabilitation.

Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation

The overall aim is to develop and test the effect of a tailored patient and family focused cardiac tele rehabilitation intervention on health literacy by comparing it to standard care. Furthermore, to evaluate health-related quality of life, family support, and how the patients experience the communication and relationship with outpatient clinic nurses.

Cardio-Fit2: Impact of a Cardiac Rehabilitation Program in Patients With Cardiovascular Disease

Cardiovascular diseases (CVD) are the main cause of morbidity and mortality in the world, being responsible for 17.9 million deaths annually, according to the World Heart Federation (WHF), which represents a significant social and health cost both due to direct expenses derived from admissions and diagnostic-therapeutic methods, as well as indirect expenses secondary to work incapacity, disability and loss of autonomy that this generates. Although advanced diagnostic and therapeutic techniques have been incorporated in recent years in the acute phase of ischemic heart disease, interventions during hospitalization and after hospital discharge remain insufficient in terms of secondary prevention, a paradoxical fact, since increasingly, the available evidence, as well as the recommendation guidelines, focus on the modification of lifestyle habits and control of cardiovascular risk factors (CVRF), fundamental pillars of cardiac rehabilitation programs (PRC) as a preventive measure both in the appearance of new adverse events and in the reduction of disease progression and improvement of the functional capacity of the patient. Cardiac rehabilitation (CR) was defined by the World Health Organization (WHO) in the 1960s as "the set of activities necessary to ensure that heart patients have an optimal physical, mental and social condition, allowing them to occupy, by their own means, as normal a place as possible in society." The scientific evidence is more than consistent regarding the benefits that multidisciplinary CRP provides in terms of cardiovascular mortality and quality of life (QoL) of our patients and how these results are maintained despite changes in patient characteristics and risk, or the incorporation of new pharmacological treatments. Therefore, if we deprive our patients of these therapies, we are indirectly acting negatively on their cardiovascular prognosis, especially within the field of ischemic heart disease, although it is increasingly being extended to other areas of Cardiology such as heart failure (HF), pulmonary hypertension (PH), valvular disease,7 etc. So much so that it is already included in the latest clinical practice guidelines of the main scientific societies at European and American level, establishing participation in a CR program after acute coronary syndrome or coronary revascularization and those patients with HF as a "level of recommendation I evidence A"

The Italian Alliance for Cardiovascular Rehabilitation and Prevention (ITACARE-P) Registry: An Observational Study on Cardiac Rehabilitation in Patients With Coronary Disease or Heart Failure

ITACARE-P CardioRehab Registry is a nationwide observational study conducted in Italy and coordinated by the Fondazione Don Carlo Gnocchi in Milan. It involves multiple hospitals and rehabilitation centers across the country and aims to better understand how cardiac rehabilitation (CR) is delivered to patients recovering from heart conditions (coronary deseases and/or heart failure). CR is a structured program that includes exercise, lifestyle education, and psychological support, and is known to improve recovery, reduce future cardiac events, lower hospital readmissions, and enhance quality of life. Despite strong recommendations from international guidelines, not all eligible patients are referred to CR, and its delivery varies. This study collects real-world data to describe how CR programs are implemented, evaluate patient outcomes, identify subgroups needing tailored care, and support improvements in cardiac care services in Italy. Adults who recently experienced a qualifying heart condition are enrolled and followed during their standard rehabilitation, without any changes to treatment. Data on medical history, risk factors, quality of life, functional improvements, and medication use are collected, with follow-up at 6 and 12 months. Participation involves no added risks, and personal health data is securely managed according to EU GDPR regulations using the REDCap system. The study aims to enhance the quality, consistency, and equity of cardiac rehabilitation across the country.