Clinical trial NCT06290336: Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement
Official title: Pre-operative Exercise Therapy and Patient Education Before Total Knee Replacement - Effect on Subjective Knee Function, Patient Satisfaction and Enablement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee replacement
Exercise therapy
Education
Knee function
Satisfaction
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Region Östergötland
name: Region Jönköping County
First posted: 2024-03-04
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery
timeFrame: Baseline; 1 year after surgery
measure: Patient satisfaction at 1 year after surgery
timeFrame: 1 year after surgery
measure: Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery
timeFrame: Baseline; 6 weeks after surgery
Secondary outcomes:
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
timeFrame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
measure: Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery
timeFrame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
measure: Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery
timeFrame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
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
timeFrame: 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
measure: Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery
timeFrame: Baseline; 6 weeks after surgery
measure: Change in active knee range of motion from baseline to 6 weeks after surgery
timeFrame: Baseline; 6 weeks after surgery
measure: Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery
timeFrame: Baseline; 6 weeks after surgery
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
timeFrame: 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
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
timeFrame: 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
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
timeFrame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 3 months after surgery; 1 year after surgery
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
timeFrame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery
measure: 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
timeFrame: Baseline; 8 weeks after randomization/start of intervention; 3 months after surgery; 1 year after surgery
Other outcomes:
measure: Adherence
timeFrame: 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: Description of surgical procedures
timeFrame: 6 weeks after surgery
measure: Description of post-operative physical therapy management
timeFrame: 6 weeks after surgery; 3 months after surgery; 1 year after surgery
measure: Adverse events
timeFrame: From baseline to 1 year after surgery
Locations:
city: Linkoping
country: Sweden
facility: Linkoping University
state: Ostergotland
Study officials:
affiliation: Linkoeping University
name: Marcus Ljung, PhD-student
role: STUDY_DIRECTOR
References: