[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540195":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":61,"centralContacts":65,"locations":71,"responsibleParty":111,"collaborators":114,"id":117,"slug":31,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":31,"enrollmentInfo":126,"targetDuration":31,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":74,"whyStopped":31,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"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",[72,86,94,102],{"facility":73,"status":74,"city":75,"state":31,"zip":31,"country":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Complejo Hospitalario San José","RECRUITING","Santiago","Chile",{"type":78,"coordinates":79},"Point",[80,81],-70.64827,-33.45694,{"lat":81,"lon":80},[84],{"name":85,"role":68,"phone":31,"phoneExt":31,"email":31},"Manuel Galvez",{"facility":87,"status":74,"city":75,"state":31,"zip":31,"country":76,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Hospital Clínico Universidad de Chile",{"type":78,"coordinates":89},[80,81],{"lat":81,"lon":80},[92],{"name":93,"role":68,"phone":31,"phoneExt":31,"email":31},"Karen Rouliez",{"facility":95,"status":74,"city":75,"state":31,"zip":31,"country":76,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"Hospital San Borja Arriarán",{"type":78,"coordinates":97},[80,81],{"lat":81,"lon":80},[100],{"name":101,"role":68,"phone":31,"phoneExt":31,"email":31},"Gonzalo Latin",{"facility":5,"status":74,"city":103,"state":31,"zip":31,"country":76,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Temuco",{"type":78,"coordinates":105},[106,107],-72.59738,-38.73628,{"lat":107,"lon":106},[110],{"name":67,"role":68,"phone":31,"phoneExt":31,"email":31},{"type":64,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Pamela Serón","Principal Investigator",[115],{"name":116,"class":6},"University of Chile","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":127,"type":128},152,"ESTIMATED","INTERVENTIONAL",[131],"NA","CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.",[134,135],"Heart Failure NYHA Class II","Heart Failure NYHA Class III",[137,138,139],"cardiac rehabilitation","heart failure","exercise","2024-11-27",{"date":142,"type":143},"2024-12-03","ACTUAL",{"date":145,"type":143},"2024-04-01",{"date":147,"type":128},"2027-03",{"name":5,"class":6},4]