PARQVE Prior to Total Knee Replacement

Study Overview
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Brief Summary
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Introduction: Elderly patients, the majority of the population submitted to total knee arthroplasty (TKA), have a lower capacity for adaptation to hospitalization and surgical stress. Exercise before cardiac and abdominal elective surgery was shown to reduce the number of complications. Studies have shown that preoperative exercise improves functional performance, strength and may decrease hospital stay after an ATJ. Objective: To evaluate if the program exercises before TKA improves quality of life, function, pain and body composition, time of hospitalization and number of complications of patients submitted to TKA. Methods: 44 patients awaiting TKA in IOT-HC-FMUSP will be divided into two groups. Half of the patients will undergo a multiprofessional and physical activity educational program for 20 weeks while the other half will wait for the TCA in the outpatient clinic. Patients will be evaluated through functional tests (sit-up and 30-second tests and time up and go), standardized questionnaires (WOMAC and Lequesne), quality of life scales (Euroqol-EQ-5D-5L), pain (through VAS), body composition and bone density (through densitometry), time of hospitalization and complications resulting from TKA. All of the above parameters will be assessed at baseline and 1 and 6 months after TKA. All project costs will be reported and a cost-effectiveness and cost-utility analysis will be performed.

Detailed Description
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Total knee arthroplasty (TKA) is generally advocated as an effective operation to alleviate symptoms in people suffering from knee osteoarthritis (OAJ). Such statements are often made from a medical and biomechanical perspective (in terms of low complication rates and prosthesis failure) instead of the patient's perspective (pain and functional outcome). Hawker et al. Demonstrated that almost half of the patients submitted to TKA had poor results regarding pain and function; these were mainly elderly patients with additional comorbidities. Elderly patients, a majority of the population submitted to TKA, have a lower capacity for adaptation to hospitalization and surgical stress. Exercise before cardiac and abdominal elective surgery was shown to reduce the number of complications. Pre- and postoperative physical therapy may increase the functional recovery of patients undergoing TKA. To date, a number of reviews have been available that demonstrate that preoperative exercise in subjects awaiting TKA has little value in postoperative outcomes. However, most of the included studies investigated the efficacy of preoperative exercise in generally healthy adults, while, in essence, eligible individuals with comorbidities and / or elderly were excluded. Therefore, to understand and appreciate the true potential of preoperative therapeutic exercise, the investigators needs to evaluate studies that included individuals at highest risk for disappointing outcomes after surgery. Two studies are available that investigated the merits of preoperative exercise in patients with increased risk of late functional recovery or increased length of hospital stay. Topp et al. investigated the efficacy of the therapeutic exercise in patients with low preoperative functional level pending TKA. This study demonstrated that, after 3 months, the functional performance level and strength of the preoperative exercise group was greater than the control group. Hansen et al. have demonstrated that, in the context of FAST TRACK, the preoperative therapeutic exercise in individuals with a higher risk of delayed recovery may further decrease hospital stay (one additional day) after TKA. Even excluding patients with comorbidities Villadsen et al. demonstrated that patients undergoing an exercise program before TKA recovered faster after surgery. In previous work performed by the authors, patients submitted to an education and physical activity program showed improvement in WOMAC, which can be reproduced in any basic health care unit. Thus the investigators believe that the sum of an education program associated with preoperative exercises needs to be considered as a tool to help recovery after TKA, as it is an inexpensive, well tolerated and easily implemented intervention in UBS.

Official Title
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PARQVE Prior to Total Knee Replacement

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Multiprofessional and educational Program prior to Total knee replacement TKA. (PARQVE TKA).
* Behavioral: Patients will be submitted to total knee replacement.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women diagnosed with OAK with comorbidities (metabolic syndrome, i.e. OAK + at least two overweight / central obesity, diabetes, dyslipidemia, hypertension) Age between 60 and 75 years who are waiting Total knee arthroplasty Patients not submitted to previous arthroplasty in the lower limbs. Patients not submitted to infiltration in the knees up to 6 months before the study. Patients with no personal history of cognitive, psychiatric and / or neurological disorders, whose symptoms presented at the time of evaluation are related or significantly interfere with the functions of attention, memory, logical reasoning, comprehension, in order to impair the assimilation of the given guidelines. Patients with no personal history of inflammatory arthritis (rheumatoid arthritis, for example) Patients able to read, understand and respond to questionnaires and perform functional tests. Exclusion Criteria: Missing in interventions and do not perform the tasks determined by the professionals. Patients submitted to infiltration in the knees during the study. Patients diagnosed with chronic inflammatory arthritis (rheumatoid arthritis, for example) during the study.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Multiprofessional and educational Program prior to Total knee replacement TKA. (PARQVE TKA). | Behavioral: Multiprofessional and educational Program prior to Total knee replacement TKA. (PARQVE TKA).<br>* Patients will participate in two days of about knee OA lectures two months apart, will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits; at months 4 and 6 to participate in a group therapy session with the psychologists, 7 sessions with the physical therapy followed by 7 sessions with the physical educators team. Following this program, patients will be operated (total knee arthroplasty). Answer Womac, VAS, Lequesne, BMI and body fat percentage - at inclusion, one week prior to surgery, 1 and 6 months postoperatively. Days of hospital stay will be measured by the number of nights the patients stay in the hospital postoperatively and also days in semi-intensive. Minutes and type of physical activity - Answer at inclusion and six months postoperatively. Perform STS30 and TUG at inclusion, one week prior to surgery, 1 and 6 months postoperatively Costs will be evaluated for cost-effectiveness and cost-utility analysis<br>|
| Active Comparator: Control<br>Patients will be submitted to total knee replacement. | Behavioral: Patients will be submitted to total knee replacement.<br>* Patients will be submitted to total knee replacement, without Multiprofessional and educational Program Answer Womac, VAS, Lequesne, BMI and body fat percentage - at inclusion, one week prior to surgery, 1 and 6 months postoperatively. Days of hospital stay will be measured by the number of nights the patients stay in the hospital postoperatively and also days in semi-intensive. Minutes and type of physical activity - Answer at inclusion and six months postoperatively. Perform the STS30 and TUG at inclusion, one week prior to surgery, 1 and 6 months postoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change the functional results of patients in the sit to stand 30 seconds | To evaluate whether the multiprofessional treatment program and exercises improves the functional results of patients in the sit to stand 30 seconds (STS30) in the 6th. month of the study (Project PARQVE prior to TKA). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improves results of Sit to Stand 30 Seconds Test | Perform Sit to Stand 30 Seconds Test - Involves recording the number of stands a person can complete in 30 seconds, more fast better. | 1 month | 
| Improves results of Time Up and Go Test | Perform Time Up and Go Test - The time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down, faster perform better. | 1 month and 6 months | 
| Improves results of Womac Questionnaire | Answer Womac Questionnaire - Ranges: minimum 0 (Better, no pain and limitation) / maximum 96 (Worst pain and limitation) | 1 month and 6 months | 
| Improves results of Lequesne Questionnaire | Answer Lequesne Questionnaire - Ranges: minimum 0 (Better, no limitation) / maximum 24 (Worst limitation) | 1 month and 6 months | 
| Improves results of Visual Analogue Scale | Answer Visual Analogue Scale - Ranges: minimum 0 (Better, no pain) / maximum 100 (Worst pain) | 1 month and 6 months | 
| Improves results of EuroQol Scale | Answer EuroQol Scale - Ranges: minimum 0 (Better) / maximum 2 (Worst) | 1 month and 6 months | 
| Increases lean mass percentage | Calculate lean mass | 1 month and 6 months | 
| Decreases fat percentage | Calculate fat percentage | 1 month and 6 months | 
| Increases minutes per week of physical activity | Answer questionnaire | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, Exercise, Preoperative, Complications