[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540195":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":61,"centralContacts":65,"locations":71,"responsibleParty":112,"collaborators":115,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":31,"enrollmentInfo":128,"targetDuration":31,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":74,"whyStopped":31,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Universidad de La Frontera","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Comprehensive Hybrid Cardiac Rehabilitation","EXPERIMENTAL","The 24-week Cardiac Rehabilitation intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a health center, transitioning to home in 4 stages.",[13,14,15,16,17,18],"Other: Comprehensive Initial Assessment","Other: Continuous evaluation","Other: Interval Exercise","Behavioral: Psychosocial support","Other: Diet management","Other: Resistance exercise",{"label":20,"type":21,"description":22,"interventionNames":23},"Exercise and center-based Cardiac Rehabilitation","ACTIVE_COMPARATOR","Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises.",[18,24,25],"Other: Continuous exercise","Other: Initial Assessment",[27,32,36,40,45,49,53,57],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Comprehensive Initial Assessment","Initial Assessment includes all those necessary to prescribe exercise training, as well as dietary and adherence promotion interventions.\n\n* Functional capacity with 6MWT\n* Assessment of skeletal muscle strength, flexibility, and balance.\n* Assessment of function\n* Assessment of dietary habits\n* Assessment of self-efficacy and barriers to CR adherence.\n* Screening for depression.",[9],null,{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Continuous evaluation","Evaluations during the course of the program will be carried out to inform the progression through the CR stages, the intensity of training and education needs.",[9],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Interval Exercise","High-intensity interval training prescribed by physical therapist:\n\n* According to an adapted Wisloff protocol.\n* Borg scale to monitor intensity.\n* Training 3 times per week.",[9],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"BEHAVIORAL","Psychosocial support","Based on social-cognitive theory, with self-efficacy as a focus:\n\n* Face-to-face sessions in the first stage of the program: Education, self-monitoring and motivational interview.\n* Face-to-face session in the second stage of the program: promoting behavior changes by self-control and self-monitoring\n* Regular communication with patients will be supported by the use of mobile devices during the third and fourth stages of program.",[9],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":31},"Diet management","A dietary plan supported by a nutritionist will be made together with the patient.",[9],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":31},"Resistance exercise","Resistance exercises:\n\n* With TheraBand.\n* Intensity according to the perceived exertion scale\n* Twice a week.",[9,20],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":31},"Continuous exercise","Moderate-intensity continuous exercise prescribed by physical therapist :\n\n* The intensity will be moderate, as tolerated\n* Borg scale to monitor intensity.\n* Frequency of training of 1 to 3 times per week, until completed 20 sessions in 10-12 weeks.",[20],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":31},"Initial Assessment","Includes all those necessary to plan exercise training, as usual:\n\n* Functional capacity with 6MWT.\n* Assessment of skeletal muscle strength.",[20],[62],{"name":63,"affiliation":5,"role":64},"Pamela Seron, PhD","PRINCIPAL_INVESTIGATOR",[66],{"name":67,"role":68,"phone":69,"phoneExt":31,"email":70},"Francisca Contreras","CONTACT","56045 2325765","mariafrancisca.contreras@ufrontera.cl",[72,87,95,103],{"facility":73,"status":74,"city":75,"state":31,"zip":31,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Complejo Hospitalario San José","RECRUITING","Santiago","Chile","CL",{"type":79,"coordinates":80},"Point",[81,82],-70.64827,-33.45694,{"lat":82,"lon":81},[85],{"name":86,"role":68,"phone":31,"phoneExt":31,"email":31},"Manuel Galvez",{"facility":88,"status":74,"city":75,"state":31,"zip":31,"country":76,"countryCode":77,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"Hospital Clínico Universidad de Chile",{"type":79,"coordinates":90},[81,82],{"lat":82,"lon":81},[93],{"name":94,"role":68,"phone":31,"phoneExt":31,"email":31},"Karen Rouliez",{"facility":96,"status":74,"city":75,"state":31,"zip":31,"country":76,"countryCode":77,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Hospital San Borja Arriarán",{"type":79,"coordinates":98},[81,82],{"lat":82,"lon":81},[101],{"name":102,"role":68,"phone":31,"phoneExt":31,"email":31},"Gonzalo Latin",{"facility":5,"status":74,"city":104,"state":31,"zip":31,"country":76,"countryCode":77,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Temuco",{"type":79,"coordinates":106},[107,108],-72.59738,-38.73628,{"lat":108,"lon":107},[111],{"name":67,"role":68,"phone":31,"phoneExt":31,"email":31},{"type":64,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Pamela Serón","Principal Investigator",[116],{"name":117,"class":6},"University of Chile","100540195","comprehensive-hybrid-cardiac-rehabilitation-trial-on-heart-failure-100540195",false,"NCT06313684","Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure","Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients","COCREATIONHF","Inclusion Criteria:\n\n* Adult patients with HF of New York Heart Association functional class II or III.\n* Meets HF diagnostic criteria of Guidelines\n* On optimal tolerated medical therapy.\n* Deemed by the treating physician as stable for at least 1 month.\n* Able to attend the health center three times a week for the first month, and twice a week for the 2nd and 3rd months\n* Owns a mobile phone\n* Patient consents to participate in the study by signing an informed consent form.\n\nExclusion Criteria:\n\n* Chronic kidney disease with glomerular filtration rate \\\u003C 20 mL\u002Fmin.\n* Decompensated thyroid disease.\n* End-stage liver failure or Child-Pugh C.\n* Cardiac device or cardiac surgery in the previous month or planned in the next 3 months.\n* Patients with dyspnea predominantly of non-cardiac cause (e.g. COPD).\n* Atrial fibrillation with a heart rate greater than 90 beats per minute at rest.\n* Active neoplasm with life expectancy \\\u003C2 years.\n* Inclusion in another interventional study.\n* Explicit contraindications to performing exercise.\n* Comorbidities that preclude the patient from engaging in a CR program.\n* Musculoskeletal or neurological disease that precludes the patient from performing exercise.","ALL","18 Years",{"count":129,"type":130},152,"ESTIMATED","INTERVENTIONAL",[133],"NA","CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.",[136,137],"Heart Failure NYHA Class II","Heart Failure NYHA Class III",[139,140,141],"cardiac rehabilitation","heart failure","exercise","2024-11-27",{"date":144,"type":145},"2024-12-03","ACTUAL",{"date":147,"type":145},"2024-04-01",{"date":149,"type":130},"2027-03",{"name":5,"class":6},4]