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

NCT ID: NCT06290336

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2027-12-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Pre-operative exercise therapy and education before knee replacement surgery

Group Type: EXPERIMENTAL

Pre-operative exercise therapy and education

Intervention Type: 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.

Standardized pre-operative information session

Intervention Type: 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

Standard care

Group Type: OTHER

Standardized pre-operative information session

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Östergötland

OTHER

Sponsor Role: collaborator

Region Jönköping County

OTHER_GOV

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Joanna Kvist

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcus Ljung, PhD-student

Role: STUDY_DIRECTOR

Linkoeping University

Locations

Linkoping University

Linköping, Östergötland County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Marcus Ljung, PhD-student

Role: CONTACT

marcus.ljung@regionostergotland.se

+4610-1043861

Joanna Kvist, Professor

Role: CONTACT

joanna.kvist@liu.se

+46732713077

Facility Contacts

Joanna Kvist, Professor

Role: primary

joanna.kvist@liu.se

+46 (0) 13 284664

Other Identifiers

PROTEKT

Identifier Type: -

Identifier Source: org_study_id