Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorLinkoeping University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pre-operative exercise therapy and education
Other interventionPre-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 interventionAs 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 2 interventions
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Baseline; 1 year after surgery2
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.
Time frame
Baseline; 6 weeks after surgerySecondary outcomes
1
Patient satisfaction at 1 year after surgery
5 item Likert scale ranging from very dissatisfied to very satisfied
Time frame
1 year after surgery2
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
Time frame
Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery3
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
Time frame
Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery4
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
Time frame
Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgeryOther outcomes
1
Adherence
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.
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.2
Description of surgical procedures
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.
Time frame
6 weeks after surgery3
Description of post-operative physical therapy management
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.
Time frame
6 weeks after surgery; 3 months after surgery; 1 year after surgery4
Adverse events
Adverse events, such as injuries during intervention participation, re-surgeries, post-operative infections and deaths, are recorded for all patients.
Time frame
From baseline to 1 year after surgerySponsors and contacts
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Source ClinicalTrials.gov