PARQVE Prior to Total Knee Replacement

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

Interventions

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

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Guilherme P Ocampos, MD · University of São Paulo General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-01

Primary Completion

2019-10-30

Completion

2020-04-30

Countries

• Brazil

Study Locations