Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement — PROTEKT  

Knee Osteoarthritis Clinical Trial

Official title: Pre-operative Exercise Therapy and Patient Education Before Total Knee Replacement - Effect on Subjective Knee Function, Patient Satisfaction and Enablement

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT06290336
• Study type: Interventional
• Source: Linkoeping University
• Contact: Marcus Ljung, PhD-student
• Phone: +4610-1043861
• Email: marcus.ljung@regionostergotland.se
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Completion date: December 30, 2026