[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538400":3},{"organization":4,"outcomesModule":7,"designInfo":76,"detailedDescription":87,"studyPopulation":81,"armGroups":88,"interventions":101,"overallOfficials":110,"centralContacts":114,"locations":123,"responsibleParty":143,"collaborators":146,"id":151,"slug":81,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":152,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":81,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":126,"whyStopped":81,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"Linkoeping University","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":59},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery","Patient-reported outcome measure (PROM) where patients assesses how aware they are of their affected knee on a 5 item Likert scale in 12 different situations in daily living. The result is summarized into a total result on a 0-100 scale, with 0 being worst (high awareness) and 100 being best (low awareness)","Baseline; 1 year after surgery",{"measure":14,"description":15,"timeFrame":16},"Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery","6-item PROM where patients are asked to assess their ability to cope with life, understand and cope with their disease, ability to stay healthy and help themselves etc during the last 4 weeks. Items are answered in a 5-item Likert scale ranging from extremely well to not at all. Results are summarized into a total score from 6 to 30, with higher scores indicating better enablement.","Baseline; 6 weeks after surgery",[18,22,26,29,32,36,38,40,42,45,48,51,55],{"measure":19,"description":20,"timeFrame":21},"Patient satisfaction at 1 year after surgery","5 item Likert scale ranging from very dissatisfied to very satisfied","1 year after surgery",{"measure":23,"description":24,"timeFrame":25},"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","Seated, using fixed dynamometer","Baseline; 8 weeks after randomization\u002Fstart of intervention; 1-2 weeks before surgery",{"measure":27,"description":28,"timeFrame":25},"Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery","Supine, using goniometer",{"measure":30,"description":31,"timeFrame":25},"Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery","Maximal number of completed repetitions in 30 seconds",{"measure":33,"description":34,"timeFrame":35},"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","PROM with 5 sub-categories on different topics regarding pain, symptoms, activities in daily living, sports and recreation and quality of life. Results are summarized in a 0-100 scale with 0 being worst and 100 best","Baseline; 8 weeks after randomization\u002Fstart of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery",{"measure":37,"description":31,"timeFrame":16},"Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery",{"measure":39,"description":28,"timeFrame":16},"Change in active knee range of motion from baseline to 6 weeks after surgery",{"measure":41,"description":24,"timeFrame":16},"Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery",{"measure":43,"description":44,"timeFrame":35},": 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","PROM in five dimensions on different topics of state of health answered in a three-level scale. Values are anchored at 1 (full health) and 0 (a state as bad as being dead), allowing also negative values. The outcome also includes a grading of the patients' perceived state of health on a Visual Analogue Scale (VAS) 0-100, with 0 being worst possible state of health and 100 being best possible state of health",{"measure":46,"description":47,"timeFrame":35},"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","PROM in 4 sub-categories with follow-up questions where patients assess their physical activity habits. Results are summarized into three categories; low, moderate or high physical activity",{"measure":49,"description":15,"timeFrame":50},"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","Baseline; 8 weeks after randomization\u002Fstart of intervention; 1-2 weeks before surgery; 3 months after surgery; 1 year after surgery",{"measure":52,"description":53,"timeFrame":54},"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","PROM where patients assess how aware they are of their affected knee on a 5 item Likert scale in 12 different situations in daily living. The result is summarized into a total result on a 0-100 scale, with 0 being worst (high awareness) and 100 being best (low awareness)","Baseline; 8 weeks after randomization\u002Fstart of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery",{"measure":56,"description":57,"timeFrame":58},"Change in objectively measured physical activity and sedentary habits via accelerometer, from baseline to 8 weeks after start of intervention, 3 months and 1 year after surgery","Physical activity and sedentary habits is objectively measured via the activPAL™ accelerometer. It is attached to the front of the thigh of the affected leg and is worn 24 hours a day for 7 days.","Baseline; 8 weeks after randomization\u002Fstart of intervention; 3 months after surgery; 1 year after surgery",[60,64,68,72],{"measure":61,"description":62,"timeFrame":63},"Adherence","Adherence to the intervention, exercise therapy protocol and education conversations is registered at each session. An exercise journal is kept for all patients and the number of exercises, exercise variations performed, dosage and load used and education topics discussed is recorded.","From initiation of the intervention until the 8 week follow-up, and then continuously ongoing if surgery date is schedueled after the 8 week follow up.",{"measure":65,"description":66,"timeFrame":67},"Description of surgical procedures","Information about surgical procedure specifics, such as type of knee replacement, patella button\u002Fresurfacing or not, soft tissue procedures outside of standard practise, is collected through patients' medical journals at the 6 week follow up.","6 weeks after surgery",{"measure":69,"description":70,"timeFrame":71},"Description of post-operative physical therapy management","Brief description of post-operative physical therapy management for all patients is collected via forms at the 6-, 12- and 52-week post-operative follow-up assessments.","6 weeks after surgery; 3 months after surgery; 1 year after surgery",{"measure":73,"description":74,"timeFrame":75},"Adverse events","Adverse events, such as injuries during intervention participation, re-surgeries, post-operative infections and deaths, are recorded for all patients.","From baseline to 1 year after surgery",{"allocation":77,"interventionModel":78,"interventionModelDescription":79,"primaryPurpose":80,"observationalModel":81,"timePerspective":81,"maskingInfo":82},"RANDOMIZED","PARALLEL","Multi-center randomized controlled trial","TREATMENT",null,{"masking":83,"maskingDescription":84,"whoMasked":85},"SINGLE","Outcome assessor blinded to group allocation",[86],"OUTCOMES_ASSESSOR","Eligible patients will be randomized through opaque concealed envelopes stratified by age (≤ 67 years, \\> 67 years) with a 1:1 allocation ratio into the intervention or the control group, after getting a decision for surgery from the surgeon. Inclusion and exclusion criteria are described in a section below. The envelopes and allocation list will be kept in a locked fire-proof storage in a different building than where the allocation process will take place.\n\nThe patients in the intervention group will participate in pre-operative supervised exercise therapy and education, continuously ongoing from point of surgery decision until surgery. Twice a week, approximately one hour\u002Fsession. Training consists of individualized strength, balance and mobility exercises, and education consists of ongoing individualized discussion regarding patients' expectations of post-operative recovery, pain and swelling, course of rehabilitation, long term function and activity level etc.\n\nPatients in both groups will participate in a standardized pre-operative information session, approximately 2 weeks before surgery. General information regarding preparations before surgery (e.g. preparing the home environment), events during the hospital stay and the rehabilitation process after discharge will be provided as part of the standard care procedure.\n\nPatients in the control group will participate in the standardized pre-operative information session mentioned above. They will not receive any specific information regarding training and exercise or individualized education outside of regular discussion with the surgeon when consenting to\u002Fmaking the decision for surgery.\n\nBaseline and follow-up measures after 8 weeks, 1-2 weeks before surgery and 6 weeks after surgery will include objective and patient reported outcome measures. Follow-up measures 3 months and 1 year after surgery will consist of patient reported outcome measures only.",[89,96],{"label":90,"type":91,"description":92,"interventionNames":93},"Intervention group","EXPERIMENTAL","Pre-operative exercise therapy and education before knee replacement surgery",[94,95],"Other: Pre-operative exercise therapy and education","Other: Standardized pre-operative information session",{"label":97,"type":98,"description":99,"interventionNames":100},"Control group","OTHER","Standard care",[95],[102,106],{"type":98,"name":103,"description":104,"armGroupLabels":105,"otherNames":81},"Pre-operative exercise therapy and education","Pre-operative supervised exercise therapy consisting of individualized strength, mobility and balance exercises and continuous education through individual discussions of expectations of post-operative recovery, pain and swelling, course of rehabilitation, long term function and activity level etc. Twice a week, approximately one hour\u002Fsession.",[90],{"type":98,"name":107,"description":108,"armGroupLabels":109,"otherNames":81},"Standardized pre-operative information session","As part of the standard care procedure, patients in the intervention and control group will participate in a standardized pre-operative information session approximately 2 weeks before surgery. General information regarding preparations before surgery (e.g. preparing the home environment), events during the hospital stay and the rehabilitation process after discharge will be provided.",[97,90],[111],{"name":112,"affiliation":5,"role":113},"Marcus Ljung, PhD-student","STUDY_DIRECTOR",[115,119],{"name":112,"role":116,"phone":117,"phoneExt":81,"email":118},"CONTACT","+4610-1043861","marcus.ljung@regionostergotland.se",{"name":120,"role":116,"phone":121,"phoneExt":81,"email":122},"Joanna Kvist, Professor","+46732713077","joanna.kvist@liu.se",[124],{"facility":125,"status":126,"city":127,"state":128,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":137,"contacts":138},"Linkoping University","RECRUITING","Linköping","Östergötland County","58183","Sweden","SE",{"type":133,"coordinates":134},"Point",[135,136],15.62157,58.41086,{"lat":136,"lon":135},[139,141],{"name":120,"role":116,"phone":140,"phoneExt":81,"email":122},"+46 (0) 13 284664",{"name":120,"role":142,"phone":81,"phoneExt":81,"email":81},"PRINCIPAL_INVESTIGATOR",{"type":142,"investigatorFullName":144,"investigatorTitle":145,"investigatorAffiliation":5,"oldNameTitle":81,"oldOrganization":81},"Joanna Kvist","Professor",[147,149],{"name":148,"class":98},"Region Östergötland",{"name":150,"class":6},"Region Jönköping County","100538400",false,"NCT06290336","Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement","Effect of Prehabilitation Before Total Knee Replacement on Post-operative Patient-reported Joint Awareness, Enablement and Knee Function","PROTEKT","Inclusion Criteria:\n\n* Waiting list for primary unilateral knee replacement surgery\n* Osteoarthritis of the knee being the primary reason for surgery\n* Reside within 60 minutes of travel to the site of the intervention\n\nExclusion Criteria:\n\n* Previous knee replacement surgery in the other knee\n* Other reason than osteoarthritis of the knee as the primary reason for surgery\n* Impaired cognitive function\n* Not being independent speaking and reading in swedish language\n* Chronic illness or disability etc hindering full participation in the intervention","ALL","40 Years","85 Years",{"count":162,"type":163},110,"ESTIMATED","INTERVENTIONAL",[166],"NA","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.\n\nThe main questions it aims to answer are:\n\n* Does pre-operative exercise therapy and education lead to better subjective knee function compared to standard care one year after surgery?\n* Does pre-operative exercise therapy and education lead to a higher level of patient satisfaction compared to standard care one year after surgery?\n* Does pre-operative exercise therapy and education lead to better patient enablement compared to standard care six weeks after surgery?\n* Does pre-operative exercise therapy and education lead to better objective knee function compared to standard care six weeks after surgery?\n\nParticipants will be randomized stratified by age (≤ 67 years, \\> 67 years) to either pre-operative supervised individualized exercise therapy combined with education two sessions\u002Fweek (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.",[169],"Knee Osteoarthritis",[171,172,173,174,175],"Knee replacement","Exercise therapy","Education","Knee function","Satisfaction","2026-01-30",{"date":178,"type":179},"2026-02-03","ACTUAL",{"date":181,"type":179},"2024-02-26",{"date":183,"type":163},"2027-12-30",{"name":5,"class":6},1]