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PARQVE Prior to Total Knee Replacement

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Multiprofessional and educational Program prior to Total knee replacement TKA. (PARQVE TKA).
Patients will be submitted to total knee replacement.
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total knee arthroplasty, Exercise, Preoperative, Complications

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

Multiprofessional and educational Program prior to Total knee replacement TKA. (PARQVE TKA).

Patients will be submitted to total knee replacement.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
Improves results of Womac Questionnaire
Answer Womac Questionnaire - Ranges: minimum 0 (Better, no pain and limitation) / maximum 96 (Worst pain and limitation)
Improves results of Lequesne Questionnaire
Answer Lequesne Questionnaire - Ranges: minimum 0 (Better, no limitation) / maximum 24 (Worst limitation)
Improves results of Visual Analogue Scale
Answer Visual Analogue Scale - Ranges: minimum 0 (Better, no pain) / maximum 100 (Worst pain)
Improves results of EuroQol Scale
Answer EuroQol Scale - Ranges: minimum 0 (Better) / maximum 2 (Worst)
Increases lean mass percentage
Calculate lean mass
Decreases fat percentage
Calculate fat percentage
Increases minutes per week of physical activity
Answer questionnaire

Full Information

First Posted
June 26, 2019
Last Updated
July 25, 2019
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04017858
Brief Title
PARQVE Prior to Total Knee Replacement
Official Title
PARQVE Prior to Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Anticipated)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total knee arthroplasty, Exercise, Preoperative, Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Multiprofessional and educational Program prior to Total knee replacement TKA. (PARQVE TKA).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients will be submitted to total knee replacement.
Intervention Type
Behavioral
Intervention Name(s)
Multiprofessional and educational Program prior to Total knee replacement TKA. (PARQVE TKA).
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Patients will be submitted to total knee replacement.
Intervention Description
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 Measure Information:
Title
Change the functional results of patients in the sit to stand 30 seconds
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improves results of Sit to Stand 30 Seconds Test
Description
Perform Sit to Stand 30 Seconds Test - Involves recording the number of stands a person can complete in 30 seconds, more fast better.
Time Frame
1 month
Title
Improves results of Time Up and Go Test
Description
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.
Time Frame
1 month and 6 months
Title
Improves results of Womac Questionnaire
Description
Answer Womac Questionnaire - Ranges: minimum 0 (Better, no pain and limitation) / maximum 96 (Worst pain and limitation)
Time Frame
1 month and 6 months
Title
Improves results of Lequesne Questionnaire
Description
Answer Lequesne Questionnaire - Ranges: minimum 0 (Better, no limitation) / maximum 24 (Worst limitation)
Time Frame
1 month and 6 months
Title
Improves results of Visual Analogue Scale
Description
Answer Visual Analogue Scale - Ranges: minimum 0 (Better, no pain) / maximum 100 (Worst pain)
Time Frame
1 month and 6 months
Title
Improves results of EuroQol Scale
Description
Answer EuroQol Scale - Ranges: minimum 0 (Better) / maximum 2 (Worst)
Time Frame
1 month and 6 months
Title
Increases lean mass percentage
Description
Calculate lean mass
Time Frame
1 month and 6 months
Title
Decreases fat percentage
Description
Calculate fat percentage
Time Frame
1 month and 6 months
Title
Increases minutes per week of physical activity
Description
Answer questionnaire
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Decreases length of hospital stay
Description
Make an economic evaluation of the program regarding cost-effectiveness and cost-utility.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Livia Abreu
Phone
1126612473
Email
murmedicina@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilherme P Ocampos, MD
Organizational Affiliation
University of São Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23459843
Citation
Hawker GA, Badley EM, Borkhoff CM, Croxford R, Davis AM, Dunn S, Gignac MA, Jaglal SB, Kreder HJ, Sale JE. Which patients are most likely to benefit from total joint arthroplasty? Arthritis Rheum. 2013 May;65(5):1243-52. doi: 10.1002/art.37901.
Results Reference
background
PubMed Identifier
24500337
Citation
Hoogeboom TJ, Dronkers JJ, Hulzebos EH, van Meeteren NL. Merits of exercise therapy before and after major surgery. Curr Opin Anaesthesiol. 2014 Apr;27(2):161-6. doi: 10.1097/ACO.0000000000000062.
Results Reference
background
PubMed Identifier
23496209
Citation
Mak JC, Fransen M, Jennings M, March L, Mittal R, Harris IA; National Health and Medical Research Council (NHMRC) of Australia. Evidence-based review for patients undergoing elective hip and knee replacement. ANZ J Surg. 2014 Jan-Feb;84(1-2):17-24. doi: 10.1111/ans.12109. Epub 2013 Mar 15.
Results Reference
background
PubMed Identifier
22675429
Citation
Hoogeboom TJ, Oosting E, Vriezekolk JE, Veenhof C, Siemonsma PC, de Bie RA, van den Ende CH, van Meeteren NL. Therapeutic validity and effectiveness of preoperative exercise on functional recovery after joint replacement: a systematic review and meta-analysis. PLoS One. 2012;7(5):e38031. doi: 10.1371/journal.pone.0038031. Epub 2012 May 31.
Results Reference
background
PubMed Identifier
19695525
Citation
Topp R, Swank AM, Quesada PM, Nyland J, Malkani A. The effect of prehabilitation exercise on strength and functioning after total knee arthroplasty. PM R. 2009 Aug;1(8):729-35. doi: 10.1016/j.pmrj.2009.06.003.
Results Reference
background
PubMed Identifier
22293051
Citation
Hansen TB, Bredtoft HK, Larsen K. Preoperative physical optimization in fast-track hip and knee arthroplasty. Dan Med J. 2012 Feb;59(2):A4381.
Results Reference
background
PubMed Identifier
23661494
Citation
Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial. Ann Rheum Dis. 2014 Jun;73(6):1130-7. doi: 10.1136/annrheumdis-2012-203135. Epub 2013 May 9.
Results Reference
background
PubMed Identifier
21335930
Citation
Wright AA, Cook CE, Baxter GD, Dockerty JD, Abbott JH. A comparison of 3 methodological approaches to defining major clinically important improvement of 4 performance measures in patients with hip osteoarthritis. J Orthop Sports Phys Ther. 2011 May;41(5):319-27. doi: 10.2519/jospt.2011.3515. Epub 2011 Feb 18.
Results Reference
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PARQVE Prior to Total Knee Replacement

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