[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536111":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":37,"locations":46,"responsibleParty":74,"collaborators":77,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":29,"enrollmentInfo":89,"targetDuration":29,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":29,"overallStatus":49,"whyStopped":29,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"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",[47,63],{"facility":48,"status":49,"city":50,"state":29,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"UZ Ghent","RECRUITING","Ghent","9000","Belgium","BE",{"type":55,"coordinates":56},"Point",[57,58],3.71667,51.05,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":29,"phoneExt":29,"email":29},"Calders Patrick, PhD",{"facility":64,"status":49,"city":65,"state":29,"zip":66,"country":52,"countryCode":53,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"UZ Leuven","Leuven","3000",{"type":55,"coordinates":68},[69,70],4.70093,50.87959,{"lat":70,"lon":69},[73],{"name":32,"role":39,"phone":29,"phoneExt":29,"email":29},{"type":33,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Amaryllis Van Craenenbroeck","Professor",[78],{"name":36,"class":6},"100536111","home-based-exercise-and-physical-activity-intervention-after-kidney-transplantation-impact-of-exercise-intensity-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":90,"type":91},147,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97,98,99,100,101,102,103,104,105],"Physical Activity","Exercise Training","Kidney Transplantation","Physical Fitness","Cardiovascular Health","Gut Microbiome","Health-related Quality of Life","Implementation","Cost-effectiveness","2024-02-07",{"date":108,"type":109},"2024-02-15","ACTUAL",{"date":111,"type":109},"2022-11-14",{"date":113,"type":91},"2029-12",{"name":5,"class":6},2]