protocolSection identificationModule nctId: NCT06359444, orgStudyIdInfo id: ONZ-2023-0453, briefTitle: Effect of High Intensity Exercise Rehabilitation on Liver Function and Insulin Sensitivity in Patients With MASLD, acronym: CENSORIAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University Ghent, class: OTHER, collaborators name: University Hospital, Ghent, descriptionModule briefSummary: Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, and is associated with obesity and the metabolic syndrome. Physical activity and lifestyle interventions are among the most recommended treatments for individuals with MASLD.In this RCT, we will evaluate the effect of combined exercise training "strength and aerobic training" versus "strength and high intensity training (HIIT)". The main outcome parameter is the severity of liver steatosis. Patients will be recruited at the fatty liver clinic of the UZ Gent., conditionsModule conditions: Exercise Therapy, conditions: Metabolic Dysfunction-associated Steatotic Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized in two groups: (a) combined aerobic and strength and (b) combined high intensity and strength., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The training will be given by the care provider, but in exercise therapy it is not possible to mask. The assessor will assess the patients without knowing in which group they will be randomized. Randomization will be done by an external person who is only involved for randomization. The investigator, who will be analysing data afterwords, will only see 1 or 2 as group number, but will not know which number is corresponding to which group., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: Combined aerobic + strength training, interventions name: Combined strength + HIIT training, outcomesModule primaryOutcomes measure: Liver steatosis by CAP, primaryOutcomes measure: Liver steatosis on ultrasound, secondaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Liver transaminases, secondaryOutcomes measure: Maximal exercise test, secondaryOutcomes measure: Strength, secondaryOutcomes measure: Cardiovascular function, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Heigth, secondaryOutcomes measure: BMI, secondaryOutcomes measure: waist, secondaryOutcomes measure: BIA, secondaryOutcomes measure: Interleukine, secondaryOutcomes measure: TNF-alfa, secondaryOutcomes measure: Hepatokines, secondaryOutcomes measure: Myokines, secondaryOutcomes measure: Adipokines, secondaryOutcomes measure: SF-36, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-01-29, uploadDate: 2024-03-23T04:06, filename: SAP_000.pdf, size: 133707, hasResults: False