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

NCT06290336 | Recruiting

• 1 other identifier: PROTEKT
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee replacement; Exercise therapy; Education; Knee function; Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (13)

• Patient satisfaction at 1 year after surgery

  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

  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

  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

  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

  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

Other Outcomes (4)

• Adherence

  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.

• Description of surgical procedures

  6 weeks after surgery

• Description of post-operative physical therapy management

  6 weeks after surgery; 3 months after surgery; 1 year after surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

Pre-operative exercise therapy and education before knee replacement surgery

Other: Pre-operative exercise therapy and education; Other: Standardized pre-operative information session

Control group

OTHER

Standard care

Other: Standardized pre-operative information session

Interventions

Pre-operative exercise therapy and education OTHER

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.

Intervention group

Standardized pre-operative information session OTHER

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.

Control group; Intervention group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead
• Region Östergötland: collaborator
• Region Jönköping County: collaborator

Study Sites (1)

Linkoping University

Linköping, Östergötland County, 58183, Sweden

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Personal Satisfaction

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Marcus Ljung, PhD-student

  Linkoeping University

  STUDY DIRECTOR

Central Study Contacts

Marcus Ljung, PhD-student

CONTACT

+4610-1043861; marcus.ljung@regionostergotland.se

Joanna Kvist, Professor

CONTACT

+46732713077; joanna.kvist@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multi-center randomized controlled trial

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 4, 2024
• Study Start: February 26, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)