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PARQVE Prior to Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT04017858
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Marcia Uchoa Rezende, University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Behavioral: Multiprofessional and educational Program prior to Total knee replacement TKA. (PARQVE TKA). Behavioral: Patients will be submitted to total knee replacement. Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PARQVE Prior to Total Knee Replacement
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Experimental
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).

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


Active Comparator: Control
Patients will be submitted to total knee replacement.
Behavioral: Patients will be submitted to total knee replacement.

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





Primary Outcome Measures :
  1. Change the functional results of patients in the sit to stand 30 seconds [ Time Frame: 6 months ]
    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).


Secondary Outcome Measures :
  1. Improves results of Sit to Stand 30 Seconds Test [ Time Frame: 1 month ]
    Perform Sit to Stand 30 Seconds Test - Involves recording the number of stands a person can complete in 30 seconds, more fast better.

  2. Improves results of Time Up and Go Test [ Time Frame: 1 month and 6 months ]
    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.

  3. Improves results of Womac Questionnaire [ Time Frame: 1 month and 6 months ]
    Answer Womac Questionnaire - Ranges: minimum 0 (Better, no pain and limitation) / maximum 96 (Worst pain and limitation)

  4. Improves results of Lequesne Questionnaire [ Time Frame: 1 month and 6 months ]
    Answer Lequesne Questionnaire - Ranges: minimum 0 (Better, no limitation) / maximum 24 (Worst limitation)

  5. Improves results of Visual Analogue Scale [ Time Frame: 1 month and 6 months ]
    Answer Visual Analogue Scale - Ranges: minimum 0 (Better, no pain) / maximum 100 (Worst pain)

  6. Improves results of EuroQol Scale [ Time Frame: 1 month and 6 months ]
    Answer EuroQol Scale - Ranges: minimum 0 (Better) / maximum 2 (Worst)

  7. Increases lean mass percentage [ Time Frame: 1 month and 6 months ]
    Calculate lean mass

  8. Decreases fat percentage [ Time Frame: 1 month and 6 months ]
    Calculate fat percentage

  9. Increases minutes per week of physical activity [ Time Frame: 6 months ]
    Answer questionnaire


Other Outcome Measures:
  1. Decreases length of hospital stay [ Time Frame: 6 months ]
    Make an economic evaluation of the program regarding cost-effectiveness and cost-utility.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017858


Contacts
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Contact: Livia Abreu 1126612473 murmedicina@outlook.com

Locations
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Brazil
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Guilherme P Ocampos, MD University of São Paulo General Hospital

Publications:

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Responsible Party: Marcia Uchoa Rezende, Full Professor in Orthopedics and Traumatology, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04017858     History of Changes
Other Study ID Numbers: 04019418.7.0000.0068
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marcia Uchoa Rezende, University of Sao Paulo General Hospital:
Total knee arthroplasty
Exercise
Preoperative
Complications

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases