[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594752":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Salerno","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TELEREHABILITATION-YES (Intervention Group)",null,"Participants will receive a structured 8-week cardiac rehabilitation program conducted entirely at home through a certified telehealth platform (Khymeia VRRS system). The intervention includes real-time supervision by a physiotherapist via videoconferencing, and the use of wearable medical devices for continuous monitoring of vital signs (ECG, heart rate, SpO₂, blood pressure) and motion tracking. Each session includes warm-up, endurance training, and cooldown exercises, with intensity personalized based on baseline cardiopulmonary testing. The platform provides automated data recording, safety alerts, and performance feedback to ensure high-quality remote care. Patients are trained in-person before starting home-based sessions to ensure proper use of the system and adherence to the protocol.",[13],"Behavioral: TELEREHABILITATION-YES",{"label":15,"type":10,"description":16,"interventionNames":17},"TELEREHABILITATION-NO (Control Group)","Participants in this group will undergo a standard 8-week cardiac rehabilitation program delivered in person at the outpatient facility under direct supervision of a physiotherapist. This group receives face-to-face rehabilitation consisting of individualized exercise sessions performed at the hospital's cardiac rehabilitation unit. Each session includes warm-up, endurance training on a stationary bike, and cooldown, following international guidelines for heart failure patients. Vital signs (heart rate, blood pressure, oxygen saturation) are manually measured and recorded by the physiotherapist, who also administers fatigue and dyspnea scales (Borg and Rate of Perceived Exertion - RPE) throughout the program. No wearable technology is used in this group; monitoring is performed through direct clinical observation and documentation in the medical record.",[18],"Behavioral: TELEREHABILITATION-NO",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"BEHAVIORAL","TELEREHABILITATION-YES","This intervention consists of a structured 8-week cardiac rehabilitation program performed at the patient's home using a certified telemedicine platform. Sessions are delivered in synchronous mode with real-time supervision by a physiotherapist through secure video conferencing. Each session includes warm-up, endurance training, and cooldown exercises, with personalized intensity based on cardiopulmonary exercise testing. Patients are equipped with wearable medical devices for continuous monitoring of vital signs (ECG, heart rate, blood pressure, oxygen saturation) and motion sensors to assess exercise execution and adherence. All data are transmitted securely and stored automatically in the system's database. In addition to the exercise protocol, participants undergo baseline and follow-up assessments including blood biomarkers, echocardiography, cardiopulmonary exercise testing, and quality-of-life questionnaires.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"TELEREHABILITATION-NO","This intervention involves a traditional 8-week cardiac rehabilitation program carried out at a hospital-based outpatient facility. Patients attend sessions in person under the direct supervision of a physiotherapist. Each session includes warm-up, endurance training using a stationary bike, and cooldown. Vital signs (e.g., heart rate, blood pressure, oxygen saturation) are monitored manually by the physiotherapist, and exercise tolerance is assessed using standardized clinical scales (e.g., Borg and RPE). In addition to the exercise protocol, participants undergo baseline and follow-up assessments including blood biomarkers, echocardiography, cardiopulmonary exercise testing, and validated quality-of-life questionnaires. This group serves as the control for evaluating the effectiveness of the home-based telerehabilitation model.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Alessia Bramanti, Electronic Engineering","CONTACT","+393483809181","abramanti@unisa.it",[36],{"facility":37,"status":38,"city":39,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hospital University San Giovanni di Dio e Ruggi d'Aragona","RECRUITING","Salerno","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],14.79328,40.67545,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":10,"phoneExt":10,"email":10},"Alessia Bramanti, Associate Professor",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Alessia Bramanti","Associate Professor",[56],{"name":57,"class":6},"Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona","100594752","effectiveness-of-a-cardiac-telerehabilitation-program-in-chronic-heart-failure-100594752",false,"NCT07023536","Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure","Evaluation of the Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure","TELEREHAB-HF","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of chronic heart failure for at least 6 months, with stable optimal medical therapy for at least 1 month\n* New York Heart Association (NYHA) functional class I, II, or III\n* Hospitalization or outpatient visit requiring intravenous therapy (diuretics, vasodilators, or inotropes) within the past 12 months\n* Ability to provide informed consent or presence of a legal representative\n* Digital literacy of the patient and\u002For caregiver\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy\n* NYHA class IV heart failure\n* Severe renal insufficiency (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m²) or on dialysis\n* Other serious illnesses significantly limiting life expectancy (e.g., end-stage cancer, advanced pulmonary disease)","ALL","18 Years",{"count":69,"type":70},205,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate whether a home-based cardiac tele-rehabilitation program can improve functional capacity in adults (18 years and older) with chronic heart failure. The main questions it aims to answer are:\n\nDoes tele-rehabilitation improve peak oxygen uptake (VO₂ max) compared to standard in-hospital rehabilitation? Does it improve cardiac function, exercise tolerance, biochemical markers, and quality of life? Are functional gains maintained at 24 weeks? Researchers will compare patients who opt for tele-rehabilitation using wearable devices and a remote monitoring platform with those undergoing standard in-person rehabilitation. Participants will follow an 8-week individualized training program and undergo assessments at baseline, 4, 8, 16, and 24 weeks.",[74],"Heart Failure",[76,77,78,79,80,81,82,83,84,85],"Chronic Heart Failure","Cardiac Rehabilitation","Tele-rehabilitation","Telemedicine","Exercise Training","Remote Monitoring","mHealth","Wearable Sensors","Home-based Rehabilitation","Digital Health","2026-03-09",{"date":88,"type":89},"2026-03-11","ACTUAL",{"date":91,"type":89},"2025-06-10",{"date":93,"type":70},"2026-12-01",{"name":5,"class":6},1]