PARQVE Prior to Total Knee Replacement

NCT04017858 | Unknown

• 1 other identifier: 04019418.7.0000.0068
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Total knee arthroplasty; Exercise; Preoperative; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Improves results of Sit to Stand 30 Seconds Test

  1 month

• Improves results of Time Up and Go Test

  1 month and 6 months

• Improves results of Womac Questionnaire

  1 month and 6 months

• Improves results of Lequesne Questionnaire

  1 month and 6 months

• Improves results of Visual Analogue Scale

  1 month and 6 months

Other Outcomes (1)

• Decreases length of hospital stay

  6 months

Study Arms (2)

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).

Control

ACTIVE COMPARATOR

Patients will be submitted to total knee replacement.

Behavioral: Patients will be submitted to total knee replacement.

Interventions

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

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

Experimental

Patients will be submitted to total knee replacement. BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, 05403-010, Brazil

Location

Related Publications (8)

• 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.

  PMID: 23459843 BACKGROUND

• 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.

  PMID: 24500337 BACKGROUND

• 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.

  PMID: 23496209 BACKGROUND

• 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.

  PMID: 22675429 BACKGROUND

• 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.

  PMID: 19695525 BACKGROUND

• Hansen TB, Bredtoft HK, Larsen K. Preoperative physical optimization in fast-track hip and knee arthroplasty. Dan Med J. 2012 Feb;59(2):A4381.

  PMID: 22293051 BACKGROUND

• 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.

  PMID: 23661494 BACKGROUND

• 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.

  PMID: 21335930 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Guilherme P Ocampos, MD

  University of São Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Livia Abreu

CONTACT

1126612473; murmedicina@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor in Orthopedics and Traumatology

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 12, 2019
• Study Start: August 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: April 30, 2020
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)