protocolSection identificationModule nctId: NCT06260579, orgStudyIdInfo id: S-number 66153, secondaryIdInfos id: S006722N, type: OTHER_GRANT, domain: Research Foundation Flanders - SBO project, briefTitle: Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity, acronym: PHOENIX-Kidney, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-14, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: KU Leuven, class: OTHER, collaborators name: University Ghent, descriptionModule briefSummary: 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., conditionsModule conditions: Physical Activity, conditions: Exercise Training, conditions: Kidney Transplantation, conditions: Physical Fitness, conditions: Cardiovascular Health, conditions: Gut Microbiome, conditions: Health-related Quality of Life, conditions: Implementation, conditions: Cost-effectiveness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel group randomized controlled trial, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Outcome assessors are blinded to the group allocation of the patients. Due to the nature of the intervention, blinding of the patients is not possible. However, a sham training intervention is provided to the control group., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 147, type: ESTIMATED, armsInterventionsModule interventions name: Exercise/physical activity, outcomesModule primaryOutcomes measure: Changes in peak oxygen consumption (VO2peak), secondaryOutcomes measure: Health-related physical fitness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Ghent, status: RECRUITING, city: Ghent, zip: 9000, country: Belgium, contacts name: Calders Patrick, PhD, role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, locations facility: UZ Leuven, status: RECRUITING, city: Leuven, zip: 3000, country: Belgium, contacts name: Amaryllis Van Craenenbroeck, MD, PhD, role: CONTACT, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False