[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649437":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":55,"locations":61,"responsibleParty":78,"collaborators":81,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":31,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":113,"whyStopped":31,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of the State of Santa Catarina","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Hybrid Cardiac Telerehabilitation (HCTR)","EXPERIMENTAL","Participants assigned to this arm will undergo a 12-week hybrid cardiac telerehabilitation program consisting of in-person sessions, synchronous activities supervised by videoconference, and asynchronous activities remotely monitored, according to the structured exercise protocol developed for this study.",[13],"Behavioral: Hybrid Cardiac Telerehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Center-Based Cardiac Rehabilitation","ACTIVE_COMPARATOR","Participants assigned to this arm will undergo a 12-week supervised traditional center-based cardiac rehabilitation program at the Center for Cardiology and Exercise Medicine (NCME\u002FUDESC), according to institutional organization and service availability, following the structured exercise protocol developed for this study.",[19],"Behavioral: Traditional Center-Based Cardiac Rehabilitation (TCR)",{"label":21,"type":16,"description":22,"interventionNames":23},"Usual Care Group","Participants assigned to this arm will remain under usual clinical care for 12 weeks, receiving standard clinical guidance and an educational booklet on the safe practice of physical exercise developed specifically for this study. The educational booklet is intended to standardize the guidance provided to participants, promote the safe practice of physical exercise, and ensure a minimum level of care throughout the study period. If clinically indicated, participants may be referred to the center-based cardiac rehabilitation program during or after the study period, subject to service availability and the participant's willingness to participate.",[24],"Behavioral: Usual Care Group",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Hybrid Cardiac Telerehabilitation","A 12-week hybrid cardiac telerehabilitation program consisting of three supervised group exercise sessions per week delivered through a hybrid model that combines in-person activities, synchronous exercise sessions via videoconference, and remotely monitored asynchronous activities. Exercise intensity will be individually prescribed based on the results of the baseline exercise stress test. The structured exercise program includes mobility and stretching exercises, light-to-moderate intensity aerobic exercise, and resistance exercises performed using elastic resistance bands. During the synchronous sessions, aerobic exercise will consist of rhythmic activities adapted for the home environment, including stationary marching, light displacement activities, alternating upper- and lower-limb movements, and low-impact functional exercises. During the asynchronous phase, participants will perform guided walking sessions and activities previously provided through instructional videos and educ",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Traditional Center-Based Cardiac Rehabilitation (TCR)","A 12-week supervised traditional center-based cardiac rehabilitation program consisting of three supervised group exercise sessions per week. Exercise intensity will be individually prescribed based on the results of the baseline exercise stress test. The structured exercise program includes mobility and stretching exercises, aerobic exercise performed primarily on a treadmill or other equipment available at the cardiac rehabilitation center, and resistance exercises performed using elastic resistance bands. The intervention was designed to improve health-related physical fitness, functional capacity, quality of life, and adherence to regular physical exercise in patients eligible for Phase II cardiac rehabilitation.",[15],{"type":27,"name":21,"description":37,"armGroupLabels":38,"otherNames":31},"Participants will remain under usual clinical care and will receive standard clinical guidance together with an educational booklet on the safe practice of physical exercise and cardiovascular health care.",[21],[40,43,46,49,51,53],{"name":41,"affiliation":5,"role":42},"Magnus Benetti, PhD","STUDY_CHAIR",{"name":44,"affiliation":5,"role":45},"Ariella S Mangia, MSc, PhD(c)","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":48,"role":42},"Artur H Herdy, PhD","Instituto de Cardiologia de Santa Catarina",{"name":50,"affiliation":48,"role":42},"Gilvan M Pinto",{"name":52,"affiliation":48,"role":42},"Cícero A de Souza, PHD",{"name":54,"affiliation":48,"role":42},"Silvana M. de S. Pereira",[56],{"name":44,"role":57,"phone":58,"phoneExt":59,"email":60},"CONTACT","55- 48- 3664-8643","48- 988714049","ariella.mangia@edu.udesc.br",[62],{"facility":63,"status":31,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Centro de Ciências da Saúde e do Esporte (CEFID\u002FUDESC)","Florianópolis","Santa Catarina","88080-350","Brazil","BR",{"type":70,"coordinates":71},"Point",[72,73],-48.54917,-27.59667,{"lat":73,"lon":72},[76],{"name":44,"role":57,"phone":77,"phoneExt":31,"email":60},"55-48-3664-8643",{"type":45,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Ariella Sebastião Mangia","Principal Investigator, PhD Candidate, Graduate Program in Human Movement Sciences, Santa Catarina State University",[82],{"name":48,"class":6},"100649437","telerehab-br-cardiovascular-rehabilitation-models-trial-100649437",false,"NCT07734831","TELEREHAB-BR: Cardiovascular Rehabilitation Models Trial","TELEREHAB-BR: A Pragmatic Randomized Controlled Trial Comparing Traditional, Hybrid Cardiac Telerehabilitation, and Usual Care Models of Cardiovascular Rehabilitation","TELEREHAB-BR","Inclusion Criteria:\n\n* Diagnosis of coronary artery disease (CAD), including patients with or without acute coronary syndrome (ACS), with or without ST-segment elevation, who were hospitalized for clinical management, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).\n* Patients with heart failure and left ventricular ejection fraction (LVEF) \\>20%. New York Heart Association (NYHA) functional class I-III.\n* Clinically stable patients without limiting angina.\n* Patients who meet the study eligibility criteria and provide informed consent to participate.\n\nExclusion Criteria:\n\n* Decompensated severe heart failure.\n* Unstable angina.\n* Atrial fibrillation with rapid ventricular response.\n* Myocarditis, recent embolism, or thrombophlebitis.\n* Disabling musculoskeletal disorders that preclude participation in the exercise program.\n* History of cardiac arrest with disabling neurological sequelae.\n* Any decompensated medical condition that precludes participation in the study.\n* More than 2 months since hospital discharge before screening.\n* No access to the internet via smartphone or computer.\n* Unable to access or use the online intervention platform.\n* Absence of a caregiver or companion available at home during participation in the study.","ALL","35 Years","80 Years",{"count":95,"type":96},219,"ESTIMATED","INTERVENTIONAL",[99],"NA","Introduction:\n\nCardiovascular diseases remain the leading cause of mortality worldwide. Despite the proven effectiveness of cardiac rehabilitation (CR) programs, adherence remains unsatisfactory, especially in public healthcare systems such as the Brazilian Unified Health System (Sistema Único de Saúde - SUS), due to logistical, geographical, and socioeconomic barriers. In this context, cardiac telerehabilitation (CTR) has emerged as a promising alternative, with effectiveness comparable to traditional center-based cardiac rehabilitation.\n\nHowever, evidence regarding hybrid cardiac telerehabilitation models applicable to the Brazilian context, using simple and low-cost technologies, remains scarce.\n\nObjectives:\n\nTo investigate adherence and its effects on the effectiveness, safety, and maintenance of exercise practice across different models of cardiac rehabilitation, with emphasis on the development and implementation of a hybrid cardiac telerehabilitation (HCTR) model adapted to the Brazilian context.\n\nThe primary outcome will be adherence to the exercise program, defined as participation in at least 75% of the proposed sessions during the 12-week intervention.\n\nSecondary outcomes will include estimated cardiorespiratory fitness, functional capacity, functional mobility, handgrip strength, and health-related quality of life.\n\nAdverse events, digital health literacy, exercise maintenance, hospitalizations, and benefits and barriers to exercise will be evaluated as exploratory variables.\n\nMethods:\n\nThis is a pragmatic, single-center, three-arm parallel randomized clinical trial consisting of hybrid cardiac telerehabilitation (HCTR), traditional center-based cardiac rehabilitation (TCR), and a usual care (UC) group.\n\nA total of 219 participants with coronary artery disease, with or without acute coronary syndrome, and\u002For stable heart failure, who are eligible for Phase II cardiac rehabilitation and receiving care through the Brazilian Unified Health System (Sistema Único de Saúde - SUS), will be enrolled.All participants will undergo standardized clinical and functional assessments at baseline, post-intervention, and short-term follow-up.\n\nClinical screening and exercise stress testing will be performed at the Santa Catarina Institute of Cardiology (Instituto de Cardiologia de Santa Catarina - ICSC), whereas physical assessments and interventions will be conducted at the Center for Cardio-Oncology and Exercise Medicine (Núcleo de Cardio-Oncologia e Medicina do Exercício - NCME), State University of Santa Catarina (UDESC).\n\nThe intervention will last 12 weeks, followed by an additional 12-week short-term follow-up period.\n\nParticipants allocated to the HCTR group will receive a hybrid intervention consisting of face-to-face sessions, synchronous sessions supervised through videoconferencing, and remotely monitored asynchronous activities.\n\nParticipants in the TCR group will participate exclusively in supervised face-to-face sessions, whereas participants in the UC group will receive usual clinical care, including conventional clinical guidance and an educational booklet.\n\nStudy Significance:\n\nThis clinical trial aims to generate evidence regarding adherence, effectiveness, safety, and maintenance of exercise practice across different models of cardiac rehabilitation. Furthermore, it seeks to provide evidence to support the development and implementation of a hybrid cardiac telerehabilitation model adapted to the Brazilian context and the Brazilian Unified Health System (SUS), contributing to expanding access to cardiac rehabilitation through accessible digital technologies.",[102,103,104],"Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))","Chronic Heart Failure","Acute Coronary Syndromes (ACS)",[106,107,108,109,110,111,112],"Coronary Artery Disease","Heart Failure","Cardiac Rehabilitation","Telerehabilitation","Exercise Therapy","Health Literacy","Exercise Adherence","NOT_YET_RECRUITING","2026-07-24",{"date":116,"type":117},"2026-07-29","ACTUAL",{"date":119,"type":96},"2026-08-03",{"date":121,"type":96},"2028-07",{"name":5,"class":6},1]