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NCT Number: NCT06290336

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Personal Satisfaction Rheumatic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linkoping University

Linköping, Östergötland County, 58183, Sweden

Location status: Recruiting

Location contact

Joanna Kvist, Professor

CONTACT

[email protected]

+46 (0) 13 284664

Joanna Kvist, Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery

    Time frame: Baseline; 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)

  2. Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery

    Time frame: Baseline; 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.

Secondary outcomes

  1. Patient satisfaction at 1 year after surgery

    Time frame: 1 year after surgery

    5 item Likert scale ranging from very dissatisfied to very satisfied

  2. 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

    Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery

    Seated, using fixed dynamometer

  3. Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery

    Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery

    Supine, using goniometer

  4. Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery

    Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery

    Maximal number of completed repetitions in 30 seconds

  5. 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

    Time frame: 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

    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

  6. Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery

    Time frame: Baseline; 6 weeks after surgery

    Maximal number of completed repetitions in 30 seconds

  7. Change in active knee range of motion from baseline to 6 weeks after surgery

    Time frame: Baseline; 6 weeks after surgery

    Supine, using goniometer

  8. Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery

    Time frame: Baseline; 6 weeks after surgery

    Seated, using fixed dynamometer

  9. : 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

    Time frame: 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

    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

  10. 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

    Time frame: 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

    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

  11. 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

    Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 3 months after surgery; 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.

  12. 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

    Time frame: Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 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)

  13. 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

    Time frame: Baseline; 8 weeks after randomization/start of intervention; 3 months after surgery; 1 year after surgery

    Physical activity and sedentary habits is objectively measured via the activPAL™ accelerometer. It is attached to the front of the thigh of the affected leg and is worn 24 hours a day for 7 days.

Other outcomes

  1. Adherence

    Time frame: 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.

    Adherence to the intervention, exercise therapy protocol and education conversations is registered at each session. An exercise journal is kept for all patients and the number of exercises, exercise variations performed, dosage and load used and education topics discussed is recorded.

  2. Description of surgical procedures

    Time frame: 6 weeks after surgery

    Information about surgical procedure specifics, such as type of knee replacement, patella button/resurfacing or not, soft tissue procedures outside of standard practise, is collected through patients' medical journals at the 6 week follow up.

  3. Description of post-operative physical therapy management

    Time frame: 6 weeks after surgery; 3 months after surgery; 1 year after surgery

    Brief description of post-operative physical therapy management for all patients is collected via forms at the 6-, 12- and 52-week post-operative follow-up assessments.

  4. Adverse events

    Time frame: From baseline to 1 year after surgery

    Adverse events, such as injuries during intervention participation, re-surgeries, post-operative infections and deaths, are recorded for all patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Joanna Kvist, Professor

CONTACT

[email protected]

+46732713077

Marcus Ljung, PhD-student

CONTACT

[email protected]

+4610-1043861

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Region Jönköping County
  • Region Östergötland

Registry information

Official study title

Effect of Prehabilitation Before Total Knee Replacement on Post-operative Patient-reported Joint Awareness, Enablement and Knee Function

Acronym: PROTEKT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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