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PARQVE Prior to Total Knee Replacement

25 lipca 2019 zaktualizowane przez: Marcia Uchoa Rezende, University of Sao Paulo General Hospital
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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

44

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • São Paulo, Brazylia, 05403-010
        • Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

60 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Experimental
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

Aktywny komparator: Control
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change the functional results of patients in the sit to stand 30 seconds
Ramy czasowe: 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).
6 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Improves results of Sit to Stand 30 Seconds Test
Ramy czasowe: 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.
1 month
Improves results of Time Up and Go Test
Ramy czasowe: 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.
1 month and 6 months
Improves results of Womac Questionnaire
Ramy czasowe: 1 month and 6 months
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
Ramy czasowe: 1 month and 6 months
Answer Lequesne Questionnaire - Ranges: minimum 0 (Better, no limitation) / maximum 24 (Worst limitation)
1 month and 6 months
Improves results of Visual Analogue Scale
Ramy czasowe: 1 month and 6 months
Answer Visual Analogue Scale - Ranges: minimum 0 (Better, no pain) / maximum 100 (Worst pain)
1 month and 6 months
Improves results of EuroQol Scale
Ramy czasowe: 1 month and 6 months
Answer EuroQol Scale - Ranges: minimum 0 (Better) / maximum 2 (Worst)
1 month and 6 months
Increases lean mass percentage
Ramy czasowe: 1 month and 6 months
Calculate lean mass
1 month and 6 months
Decreases fat percentage
Ramy czasowe: 1 month and 6 months
Calculate fat percentage
1 month and 6 months
Increases minutes per week of physical activity
Ramy czasowe: 6 months
Answer questionnaire
6 months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Decreases length of hospital stay
Ramy czasowe: 6 months
Make an economic evaluation of the program regarding cost-effectiveness and cost-utility.
6 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Guilherme P Ocampos, MD, University of Sao Paulo General Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

1 sierpnia 2019

Zakończenie podstawowe (Oczekiwany)

30 października 2019

Ukończenie studiów (Oczekiwany)

30 kwietnia 2020

Daty rejestracji na studia

Pierwszy przesłany

26 czerwca 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 lipca 2019

Pierwszy wysłany (Rzeczywisty)

12 lipca 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 lipca 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 lipca 2019

Ostatnia weryfikacja

1 lipca 2019

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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