protocolSection identificationModule nctId: NCT06290336, orgStudyIdInfo id: PROTEKT, briefTitle: Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement, acronym: PROTEKT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Linkoeping University, class: OTHER_GOV, collaborators name: Region Östergötland, collaborators name: Region Jönköping County, descriptionModule briefSummary: The goal of this multi-center randomized controlled trial is to investigate the effect of pre-operative exercise therapy and education for patients awaiting knee replacement surgery on subjective knee function, patient satisfaction and enablement compared to standard care.The main questions it aims to answer are:* Does pre-operative exercise therapy and education lead to better subjective knee function compared to standard care one year after surgery?* Does pre-operative exercise therapy and education lead to a higher level of patient satisfaction compared to standard care one year after surgery?* Does pre-operative exercise therapy and education lead to better patient enablement compared to standard care six weeks after surgery?* Does pre-operative exercise therapy and education lead to better objective knee function compared to standard care six weeks after surgery?Participants will be randomized stratified by age (≤ 67 years, \> 67 years) to either pre-operative supervised individualized exercise therapy combined with education two sessions/week (intervention group) or to standard care (control group). The intervention will be continuously ongoing for at least eight weeks from the point of decision for surgery until as close to the surgery as possible., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-center randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome assessor blinded to group allocation, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Pre-operative exercise therapy and education, interventions name: Standardized pre-operative information session, outcomesModule primaryOutcomes measure: Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery, primaryOutcomes measure: Patient satisfaction at 1 year after surgery, primaryOutcomes measure: Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery, primaryOutcomes measure: Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery, primaryOutcomes measure: Change in active knee range of motion from baseline to 6 weeks after surgery, primaryOutcomes measure: Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery, secondaryOutcomes measure: Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery, secondaryOutcomes measure: Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery, secondaryOutcomes measure: Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery, secondaryOutcomes measure: Change in Knee Osteoarthritis Outcome Score (KOOS) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery, secondaryOutcomes measure: : Change in EuroQol 5 Dimensions 3 Levels (EQ5D-3L) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery, secondaryOutcomes measure: Change in International Physical Activity Questionnaire - short form (IPAQ-sf) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery, secondaryOutcomes measure: Change in Mod-PEI-2 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery, secondaryOutcomes measure: Change in FJS-12 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery and 6 weeks and 3 months after surgery, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Linkoping University, status: RECRUITING, city: Linkoping, state: Ostergotland, zip: 58183, country: Sweden, contacts name: Joanna Kvist, Professor, role: CONTACT, phone: +46 (0) 13 284664, email: joanna.kvist@liu.se, contacts name: Joanna Kvist, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False