Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a standardized education and exercise program proposed before a total knee replacement for knee osteoarthritis is effective in functional recovery after surgery.

Detailed Description
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Knee osteoarthritis leads to deficiencies in muscle strength, knee range of motion and balance, and cardio respiratory deconditioning that contribute to alter abilities to perform activities of daily living. It is the principal indication for total knee arthroplasty (TKA). Patients' functional state and pain level are generally improved after TKA and the physical and functional status pre-TKA are predictive of recovery after surgery. Decreasing length of stay at surgery departments and promoting return at home after TKA are recommended. The recommendations of the Health Authority in France (HAS) and the new law of finance for French clinics contribute to shorter hospital stays and to restrain the conditions of admission to Physical Medicine and Rehabilitation department after TKA.Exercise and education programs conducted before TKA could help better prepare patients for surgery, improve functional outcome and accelerate functional recovery after surgery thus reducing the length of stay in orthopedic departments and facilitate return to home (directly or after a stay in PMR departments). The type of program necessary to achieve those goals remains to be defined.A systematic review of the literature associated with an analysis of practices about the relevance of rehabilitation programs before TKA, concluded that the implementation of such programs before TKA was likely to reduce the length of stay in surgery departments and improve the rate of direct return to home after surgery but that high quality trials were lacking. It also suggested that association of exercise programs with educational ones could be more effective than exercise or education alone, particularly for fragile patients with impaired functional capacity, co-morbidities and/or social problems.

Official Title
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Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Educational and exercise program
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 50 to 85 years Patient suffering from knee osteoarthritis according to ACR for which a total knee arthroplasty is scheduled Preliminary medical examination whose results will be transmitted to the patient Patient giving his informed consent to participate in the study Patient affiliated to or beneficiary of social insurance Exclusion Criteria: Patients institutionalized Patients who have already received an ipsilateral total knee arthroplasty Patients with chronic inflammatory arthritis Cognitive or behavioral disorders making assessment impossible Inability to speak and write French TKA indicated for other reason than osteoarthritis

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational and exercise program<br> | Other: Educational and exercise program<br>* 4 (twice a week) group education sessions lasting 30 minutes plus an education booklet about knee replacement 4 (twice a week) sessions of an exercise programme lasting 1 hour<br>|
| Active Comparator: Usual care<br> | Other: Usual care<br>* Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients able to quit independently the orthopedic department | Assessed by the ability to perform lying-sitting and sitting-standing transfers, walk 30 meters and go up and down one floor at day 4 (± 1 day) after the surgery. Each item will be scored on a 4-class scale (0, unable to perform and 3, able to perform independently). Ability to quite the orthopedic department will be defined as scoring 3 out of 3 for all 4 assessed items on the day of discharge from the orthopedic department. | at day 4 post-surgery | 
| Changes from baseline in functional recovery | Assessed by the area under the curve of the function subscale of the WOMAC index within the first 6 months post-surgery | 6 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in mean knee pain in the previous 48 hrs | Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain) | 6 months post-surgery | 
| Changes from baseline in mean knee pain in the previous 48 hrs | Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain) | 12 months post-surgery | 
| Changes from baseline in mean function in the previous 48 hrs | Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function) | 6 months post-surgery | 
| Changes from baseline in mean function in the previous 48 hrs | Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function) | 12 months post-surgery | 
| Changes from baseline in mean quality of life | Assessed by the physical and mental components of the self-administered SF-12 questionnaire (0, worse quality of life and 100, best quality of life) and by the self-administered EQ-5D-3L questionnaire (11111, best quality of life and 33333, worse quality of life) | 6 months post-surgery | 
| Changes from baseline in mean quality of life | Assessed by the physical and mental components of the self-administered SF-12 questionnaire (0, worse quality of life and 100, best quality of life) and by the self-administered EQ-5D-3L questionnaire (11111, best quality of life and 33333, worse quality of life) | 12 months post-surgery | 
| Changes from baseline in the mean number of steps in the previous week | Assessed by the self-reported number of steps monitored by a podometer | 6 months post-surgery | 
| Changes from baseline in the mean number of steps in the previous week | Assessed by the self-reported number of steps monitored by a podometer | 12 months post-surgery | 
| Satisfaction with the treatment | Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied) | 6 months post-surgery | 
| Satisfaction with the treatment | Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied) | 12 months months post-surgery | 
| Cost-effectiveness | Assessed by the cost-utility ratio | 6 months post-surgery | 
| Cost-effectiveness | Assessed by the cost-utility ratio | 12 months months post-surgery | 
| Adverse events | Assessed by self reporting using an open-ended question | 12 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, Total knee replacement, Knee osteoarthritis, Education, Exercise, Handicap, Function, Cost-effectiveness, Cost-utility, Quality of life