Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement
- Conditions
- Knee Osteoarthritis
- Interventions
- Other: Pre-operative exercise therapy and educationOther: Standardized pre-operative information session
- Registration Number
- NCT06290336
- Lead Sponsor
- Linkoeping University
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Standardized pre-operative information session Pre-operative exercise therapy and education before knee replacement surgery Intervention group Pre-operative exercise therapy and education Pre-operative exercise therapy and education before knee replacement surgery Control group Standardized pre-operative information session Standard care
- Primary Outcome Measures
Name Time Method Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery Baseline; 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)
Patient satisfaction at 1 year after surgery 1 year after surgery 5 item Likert scale ranging from very dissatisfied to very satisfied
Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery Baseline; 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.
- Secondary Outcome Measures
Name Time Method Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery Baseline; 6 weeks after surgery Seated, using fixed dynamometer
Change in active knee range of motion from baseline to 6 weeks after surgery Baseline; 6 weeks after surgery Supine, using goniometer
Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery Baseline; 6 weeks after surgery Maximal number of completed repetitions in 30 seconds
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 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 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
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 Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery Seated, using fixed dynamometer
Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery Supine, using goniometer
Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery Maximal number of completed repetitions in 30 seconds
: 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 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 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
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 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 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
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/start of intervention; 1-2 weeks before surgery; 3 months after surgery; 1 year 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.
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 Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 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)
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 Baseline; 8 weeks after randomization/start of intervention; 3 months after surgery; 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.
Trial Locations
- Locations (1)
Linkoping University
🇸🇪Linkoping, Ostergotland, Sweden