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

Knee Osteoarthritis Clinical Trial

— PROTEKT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290336
• Other study ID #: PROTEKT
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: March 2024
• Source: Linkoeping University
• Contact: Marcus Ljung, PhD-student
• Phone: +4610-1043861
• Email: marcus.ljung[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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, and being able to participate fully

Exclusion Criteria:

• Previous knee replacement surgery in the other knee
• Other reason than osteoarthritis of the knee as the primary reason for surgery
• Revision surgery
• Impaired cognitive function
• Not being independent speaking and reading in swedish language
• Chronic illness or disability etc hindering full participation in the intervention

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Linkoping University	Linkoping	Ostergotland

Sponsors (3)

Lead Sponsor	Collaborator
Linkoeping University	Region Jönköping County, Region Östergötland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient satisfaction at 1 year after surgery	5 item Likert scale ranging from very dissatisfied to very satisfied	1 year after surgery
Primary	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
Primary	Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery	Seated, using fixed dynamometer	Baseline; 6 weeks after surgery
Primary	Change in active knee range of motion from baseline to 6 weeks after surgery	Supine, using goniometer	Baseline; 6 weeks after surgery
Primary	Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery	Maximal number of completed repetitions in 30 seconds	Baseline; 6 weeks after surgery
Secondary	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/start of intervention; 1-2 weeks before surgery
Secondary	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	Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
Secondary	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	Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery
Secondary	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/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery
Secondary	: 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	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
Secondary	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	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
Secondary	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	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; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 3 months after surgery; 1 year after surgery
Secondary	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/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery