Clinical Research Directory

Avatar-Based Serious Game for Cardiac Rehabilitation After Heart Attack

This study looks at whether a tablet-based education game helps people recover better after a heart attack. When people leave the hospital after a heart attack, they are usually given advice about their medicines, follow-up visits, cardiac rehabilitation, and warning signs to watch for. Many people find it hard to remember all of this information later at home. In this study, adults who were treated in hospital for a heart attack were divided by chance into two groups. One group received the usual face-to-face education before going home. The other group used an interactive avatar-based education game on a tablet, in which a guide character walks the patient through the same topics. The game could also be used at home for one month after discharge. The researchers measured how much patients knew about their heart disease, their quality of life, whether they attended cardiac rehabilitation, and whether they were readmitted to hospital. These were checked before discharge and again at 1, 3, and 6 months. The goal is to learn whether the avatar-based game helps patients understand and manage their condition better than usual education.

Early Case Management on Recovery From a Cardiac Event in Women

Outpatient cardiac rehabilitation (CR) is an exercise-based lifestyle program for patients who have experienced a myocardial infarction, systolic heart failure, percutaneous revascularization or cardiac surgery. CR plays a key role in secondary prevention, which is the prevention of subsequent cardiac events. CR has been shown to reduce both cardiovascular mortality and one year hospital readmissions as well as improve quality of life, exercise capacity, and physical function. Although the benefits have been clearly established for cardiac patients, women are much less likely to attend CR than men. Based upon our own preliminary data (and the medical literature), attendance at CR is determined by factors that vary in their importance between men and women. These findings demonstrate that older age and poor social support are particular barriers to CR participation in women. This information can guide efforts to increase CR participation and adherence in women, areas which have received little study. Case management (CM) has been effective at reducing cardiovascular risk and reducing hospitalizations amongst cardiac patients. Further, CM has been effective at promoting attendance in a variety of health related programs (for example, diabetes treatment or cocaine dependence treatment). The primary aim in this randomized controlled trial is to examine the efficacy of early CM to promote participation and adherence in CR. The CM model can identify individualized determinants of health and social needs to identify potential barriers which may hinder CR enrollment. Additionally, the case manager will conduct a home visit and provide individual counseling to address lifestyle changes including physical activity. Thus, a component of CR and physical activity can be still be delivered for those unable to attend CR. The concept of CM to improve CR participation and adherence has not been specifically tested in women, a vulnerable patient population. This intervention, therefore, has the potential to increase utilization of CR and significantly improve health outcomes in female cardiac patients.

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.

Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study

In Norway, more than 11,000 patients undergo percutaneous coronary intervention (PCI) annually. However, a very recent study utilizing registry data show a national average of cardiac rehabilitation (CR) participation of only 14%, despite its proven beneficial effects on readmissions, physical capacity, psychological distress, self-management, and quality of life. CR is strongly recommended in European guidelines. However, uptake is low and is not systematically identifying those in most need of CR. The primary objective of eCardiacRehab is to meet rehabilitation needs of large patient populations regardless of their access to traditional place-based rehabilitation by developing and evaluating the efficacy and cost effectiveness of an interdisciplinary and comprehensive home-based eCardiacRehab programme. eCardiacRehab address patient- and system level challenges in order to increase access to CR. The investigators give particular attention to older patients, women, and those with comorbidities or mental health challenges. Aspects related to continuity of care between specialist and primary care services, health literacy, adherence to treatment, cost effectiveness and ethics are investigated. The investigators will 1) continue to develop the programme with patients, general practitioners, healthcare experts from both specialist and primary care services, and technology developers, 2) develop treatment modules, 3) establish information and communication infrastructure, 4) evaluate the process and efficacy of treatment modules, 5) ensure knowledge development and transfer of competence to the municipalities, and 6) contribute to fulfil the innovation potential for health service and industry partners. eCardiacRehab has the potential to improve interaction and collaboration between primary and secondary care, modernise and digitalise work processes, and develop more coherent and tailored patient pathways. The vision of the home-based eCardiacRehab is to make CR available to all.

eCardiacRehab - a Hybrid Patient-Centered eHealth Programme

The overall aim of eCardiacRehab trial is to meet rehabilitation needs of patients with coronary artery disease (CAD) regardless of their access to traditional place-based rehabilitation by developing and evaluating the efficacy and cost effectiveness of an interdisciplinary and comprehensive home-based hybrid programme. eCardiacRehab address patient- and system level challenges to increase access to cardiac rehabilitation (CR). We give particular attention to older patients, women, and those with comorbidities or mental health challenges. The vision of the hybrid home-based eCardiacRehab programme is to make CR available to all. eCardiacRehab is a prospective, multicentre randomized open-label blinded end point evaluation (PROBE) trial. The primary endpoint is a hierarchical composite endpoint using a win-ratio framework combining cardiovascular (CV) death, unplanned contacts to the Emergency Department (ED) for observation or admission (\>24 hours) for CV disease, and quality of life. Inclusion criteria are adult Scandinavian speaking patients (≥ 18 years) who have a Norwegian national identification number, with CAD treated with Percutaneous Coronary Intervention (PCI), are living at home, and have internet available to them and providing signed informed consent. Exclusion criteria are patients with severe aortic stenosis, severe arrhythmias, expected lifetime less than one year as determined by study personnel, otherwise clinically unstable, not fully revascularized, awaits PCI or coronary artery bypass graft operation (CABG) or inability to comply with the study protocol due to any physical disability, somatic disease, cognitive impairment or mental health challenges as determined by study personnel.

The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients

The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment. Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program.

Improving Veteran Referral to Cardiac Rehabilitation

This study will test whether the Veterans Cardiac Rehabilitation Referral Program (VCR2P) improves cardiac rehabilitation participation by studying 816 Veterans across three VA medical centers in Nashville, Dallas, and Gainesville over 12 months. The trial compares referral rates from the 6 months before implementing the program to 6 months after, using a "before and after" design since randomization would be impractical. The study will measure whether the program increases the proportion of eligible Veterans who receive cardiac rehabilitation referrals and whether more Veterans actually attend rehabilitation sessions. Additionally, focus groups with physicians, nurses, and Veterans will identify what helps or hinders the program's success, providing essential insights for expanding this intervention to other VA facilities nationwide if it proves effective.

Behavioral Exposure for Introceptive Tolerance RCT

Behavioral Exposure for Interoceptive Tolerance (BE-FIT) is a mechanism-informed behavioral intervention to target exercise anxiety. The three primary components of BE-FIT include: (1) exposure to feared bodily sensations and exercise; (2) prevention of safety behavior use before/during/after exercise, and (3) use of a wrist-worn activity monitor for physical activity (PA) feedback and activity goal setting. Evidence from the investigators' Stage I trial indicated that BE-FIT is feasible, acceptable, and safe and produced reductions in exercise anxiety and increased exercise outcomes (short-term moderate-to-vigorous intensity physical activity and steps/day). The investigators' present aim is to conduct a Stage II randomized-controlled trial to further evaluate the efficacy of BE-FIT in decreasing exercise anxiety in cardiac rehabilitation (CR) patients and examine whether changes in this target yield successive changes in exercise adherence outcomes.

The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants

The goal of this clinical trial is to find out if newly developed, culturally adapted educational videos-sent through a mobile messaging app-can help people with coronary heart disease do better in a home-based cardiac rehabilitation program in Malaysia. The main questions it aims to answer are: * Do the educational videos help participants improve their fitness? * Do the videos help participants better understand heart health and stick to a healthy lifestyle? Researchers will compare the educational videos to existing standard educational materials to see if the video-based education is more helpful for supporting rehabilitation at home. Participants will: * Take part in a 12-week home-based cardiac rehabilitation program * Receive either educational videos or standard education materials * Meet with the cardiac rehabilitation team every 4 weeks * Complete a treadmill exercise test, blood tests, and questionnaires before and after the program.

Educational Dietary Intervention in Early Cardiac Rehabilitation After Myocardial Infarction

The trial is designed to assess whether individualized nutritional education provides additional benefit beyond standard early cardiac rehabilitation in patients after myocardial infarction. Patients referred for cardiac rehabilitation after myocardial infarction are randomized to a control group receiving standard rehabilitation care or to an intervention group receiving standard care plus structured personalized dietary education. The educational intervention is tailored to baseline dietary habits, nutritional knowledge, and adherence to cardioprotective dietary recommendations. Outcomes include changes in diet quality, adherence to the Mediterranean diet, nutritional knowledge, anthropometric measures, and bioelectrical impedance analysis-derived body composition parameters. The study will evaluate the feasibility and effectiveness of integrating individualized dietary education into early cardiac rehabilitation after myocardial infarction.

High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation

The goal of this clinical trial is to learn if a high-flow nasal cannula (HFNC) - a device that delivers warm, humidified air through a small tube placed in the nostrils - can improve exercise tolerance in adults with heart failure (HF) who are entering a cardiac rehabilitation program. The main questions it aims to answer are: Can HFNC help people with heart failure exercise for a longer time during a treadmill test? and does HFNC lower how hard people feel they are working during exercise? Researchers will compare exercise performance with HFNC to exercise performance without HFNC to see if HFNC helps people with HF tolerate exercise better. Participants will: Complete two treadmill exercise tests, one with HFNC and one without, in a randomly assigned order. Wait 48 to 72 hours between the two tests to allow full recovery. Have their heart rate, blood pressure, oxygen level, and breathing rate measured before and after each test.

REACTION-VAD Trial: Remote Exercise Training Via Telemedicine in Patients With Long-Term Ventricular Assist Devices

Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs. However, not all patients with a heart pump are able to attend to a supervised program on a daily basis. The goal of this clinical trial is to determine whether a home-based exercise program helps patients with a heart pump improve their exercise capacity and quality of life, guided by telemedicine tools including a mobile app, smartwatch, and remote medical checkups. The study will also provide information about the safety of this program by monitoring for any issues or symptoms during home activity. The trial aims to answer the following questions: * Does a 12-week remote exercise program improve patients' exercise capacity? This will be measured using the 6-minute walk test and a cardiopulmonary exercise test. * Is it safe for patients to follow this exercise plan at home while being monitored through a mobile app and smartwatch? * Does the program improve quality of life and reduce feelings of anxiety or depression? This will be assessed using widely validated questionnaires, such as the Kansas City Cardiomyopathy Questionnaire. Researchers will compare the remote exercise program to standard care, which usually does not include exercise for patients who are unable to attend the hospital daily. Participants will: * Join the study voluntarily after signing a consent form. * Be randomly assigned, with a 50% chance of being in either the exercise group (following a structured plan with a mobile app) or the usual care group (receiving general written advice), to see which approach works best for recovery. * Follow a 12-week home-based routine if in the exercise group, including warm-up routine, walking or cycling, respiratory exercises, and light strength training, all supported by the mobile app, smartwatch, and professional monitoring. * Visit the hospital three times over six months for medical checkups, including walking and exercise tests, blood analyses, and questionnaires about physical and emotional health.

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.

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).

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.

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.

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.