[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536111":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":37,"locations":46,"responsibleParty":73,"collaborators":76,"id":78,"slug":29,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":29,"enrollmentInfo":87,"targetDuration":29,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":29,"overallStatus":49,"whyStopped":29,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"KU Leuven","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Low intensity training (LIT)","SHAM_COMPARATOR","6 months of low-intensity flexibility and balance exercises, not followed by a formal physical activity intervention",[13],"Behavioral: Exercise\u002Fphysical activity",{"label":15,"type":16,"description":17,"interventionNames":18},"Moderate-intensity training (MIT)","EXPERIMENTAL","6 months of exercise intervention (moderate intensity), followed by a co-developed physical activity intervention",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Moderate- and high-intensity training group (MHIT)","6 months of exercise intervention (moderate-intensity followed by high-intensity), followed by a co-developed physical activity intervention",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","Exercise\u002Fphysical activity","personalized exercise training and physical activity program",[9,20,15],null,[31,34],{"name":32,"affiliation":5,"role":33},"Amaryllis Van Craenenbroeck, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Patrick Calders, PhD","University Ghent",[38,42],{"name":32,"role":39,"phone":40,"phoneExt":29,"email":41},"CONTACT","+3216344580","amaryllis.vancraenenbroeck@kuleuven.be",{"name":43,"role":39,"phone":44,"phoneExt":29,"email":45},"Stefan De Smet, PhD","+32486055917","stefan.desmet@kuleuven.be",[47,62],{"facility":48,"status":49,"city":50,"state":29,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"UZ Ghent","RECRUITING","Ghent","9000","Belgium",{"type":54,"coordinates":55},"Point",[56,57],3.71667,51.05,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":29,"phoneExt":29,"email":29},"Calders Patrick, PhD",{"facility":63,"status":49,"city":64,"state":29,"zip":65,"country":52,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"UZ Leuven","Leuven","3000",{"type":54,"coordinates":67},[68,69],4.70093,50.87959,{"lat":69,"lon":68},[72],{"name":32,"role":39,"phone":29,"phoneExt":29,"email":29},{"type":33,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Amaryllis Van Craenenbroeck","Professor",[77],{"name":36,"class":6},"100536111",false,"NCT06260579","Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity","A Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity - a Multicenter Randomized Controlled Trial","PHOENIX-Kidney","Inclusion Criteria:\n\nDe novo adult KTRs\n\nExclusion Criteria:\n\n* Underlying heart disease, defined as aberrant CPET, unstable angina, non-revascularized lesions or life-threatening arrhythmias\n* Uncontrolled hypertension\n* Uncontrolled diabetes, defined as HbA1c ≥ 9%\n* Musculoskeletal disorders not allowing physical training on a cycle ergometer, or any other medical reasons by the physician considered to be a contraindication for moderate or high-intensity physical exercise\n* Multi-organ transplantation\n* Ongoing treatment for malignancies\n* Unable to understand Dutch\n* No access to smartphone and\u002For computer with internet access\n* Severe pulmonary disease defined as either forced vital capacity (FVC) \\\u003C50%, one-second value (FEV1) \\\u003C50%, or a diffusing capacity for carbon monoxide (DLCO) \\\u003C40% that excludes all serious underlying respiratory disease (pulmonary fibrosis, COPD GOLD II-IV, PAH).","ALL","18 Years",{"count":88,"type":89},147,"ESTIMATED","INTERVENTIONAL",[92],"NA","This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent.",[95,96,97,98,99,100,101,102,103],"Physical Activity","Exercise Training","Kidney Transplantation","Physical Fitness","Cardiovascular Health","Gut Microbiome","Health-related Quality of Life","Implementation","Cost-effectiveness","2024-02-07",{"date":106,"type":107},"2024-02-15","ACTUAL",{"date":109,"type":107},"2022-11-14",{"date":111,"type":89},"2029-12",{"name":5,"class":6},2]