Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pre-operative exercise therapy and education, Standardized pre-operative information session.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Prehabilitation Before Total Knee Replacement on Post-operative Patient-reported Joint Awareness, Enablement and Knee Function
Overview
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.
Detailed description
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.
The 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/session. 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.
Patients 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.
Patients 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/making the decision for surgery.
Baseline 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.
Interventions
- Other 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/session. - Other 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.
Primary outcome measures
- Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery [Time frame: Baseline; 1 year after surgery]
- Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery [Time frame: Baseline; 6 weeks after surgery]
Secondary outcome measures (12)
- Patient satisfaction at 1 year after surgery [Time frame: 1 year after surgery]
- 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 [Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery]
- Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery [Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery]
- Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery [Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery]
- 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 [Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery]
- Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery [Time frame: Baseline; 6 weeks after surgery]
- Change in active knee range of motion from baseline to 6 weeks after surgery [Time frame: Baseline; 6 weeks after surgery]
- Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery [Time frame: Baseline; 6 weeks after surgery]
- : 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 [Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery]
- 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 [Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery]
- 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 [Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 3 months after surgery; 1 year after surgery]
- 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 [Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery]
Eligibility criteria
Inclusion criteria
- Waiting list for primary unilateral knee replacement surgery
- Osteoarthritis of the knee being the primary reason for surgery
- Reside within 60 minutes of travel to the site of the intervention
Exclusion criteria
- Previous knee replacement surgery in the other knee
- Other reason than osteoarthritis of the knee as the primary reason for surgery
- Impaired cognitive function
- Not being independent speaking and reading in swedish language
- Chronic illness or disability etc hindering full participation in the intervention
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Linkoping University — Linköping
Publications
- Ljung M, Gustafsson K, Kvist J. Effect of prehabilitation before total knee replacement on postoperative patient-reported joint awareness, enablement and knee function: protocol for the PROTEKT randomised controlled trial. BMJ Open. 2026 Mar 3;16(3):e113185. doi: 10.1136/bmjopen-2025-113185. PMID 41775488
Identifiers
NCT: NCT06290336 · PROTEKT