protocolSection identificationModule nctId: NCT06302205, orgStudyIdInfo id: S66232, briefTitle: A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity, acronym: PHOENIX-L, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: KU Leuven, descriptionModule briefSummary: Research demonstrated that transplant recipients benefit from physical activity, but there is a gap in knowledge regarding the required intensity. In the PHOENIX-Liver study, researchers aim to investigate the adequate intensity of rehabilitation programs after liver transplantation. Patients will be randomized into one of the three PHOENIX-Liver training groups (low, moderate, moderate to high). The six months rehabilitation program is conducted from the patient's home but supervised by a PHOENIX-investigator.At baseline, after three months of rehabilitation and after six months of rehabilitation, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. Questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness.To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at UZ Leuven is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase., conditionsModule conditions: Liver Transplantation, conditions: Physical Fitness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two interventional groups and one control group, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The nature of the intervention does not allow blinding of study participants. However, outcome assessors and data investigators will be blinded to the participants' group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 147, type: ESTIMATED, armsInterventionsModule interventions name: Physical activity, interventions name: Sham intervention, outcomesModule primaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Functional exercise capacitiy, secondaryOutcomes measure: Hand grip strength, secondaryOutcomes measure: Knee-extensor strength, secondaryOutcomes measure: Endothelial function, secondaryOutcomes measure: Arterial stiffness, secondaryOutcomes measure: Graft function, secondaryOutcomes measure: Occurence of adverse events, secondaryOutcomes measure: Motor fitness, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Blood profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Hanne Van Criekinge, role: CONTACT, phone: +3216343162, email: hanne.vancriekinge@kuleuven.be, contacts name: Diethard Monbaliu, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False