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Набор по приглашению NCT07047079

Patient-navigation-based Preoperative Rehabilitation Exercise Program in Patients Undergoing TKA

Без фазы С лечением Total Knee Arthroplasty Knee Osteoarthritis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Autonomous preoperative rehabilitation exercises, The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services.
Кому может быть актуально
Состояния в реестре: Total Knee Arthroplasty, Knee Osteoarthritis. Базовые параметры: 45 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effectiveness of a Patient-navigation-based Preoperative Rehabilitation Exercise Program in Patients Undergoing Total Knee Arthroplasty: A Randomised Controlled Trial

Обзор

This study aimed to assess the effectiveness of a patient navigation-based preoperative rehabilitation exercise program for patients undergoing total knee arthroplasty.

Подробное описание

Participants were recruited from among patients newly admitted to the orthopaedic ward who met the selection criteria. Participants who provided written informed consent completed a survey collecting demographic and clinical information, followed by a baseline assessment (T0). Subsequently, they were randomly assigned to either the control group or the experimental group. Participants in both groups received standardised, identical inpatient rehabilitation and nursing services throughout their hospitalisation. From admission day to surgery day (preoperative), control group participants will receive an autonomous preoperative rehabilitation exercise programme, while experimental group participants will receive a patient-navigation-based preoperative rehabilitation exercise programme

Вмешательства

  • Другое Autonomous preoperative rehabilitation exercises
    1. Method: On the day of admission, a research assistant provided a verbal explanation of the preoperative rehabilitation exercise regimen and distributed a guidance manual. Participants are advised to perform self-directed exercises 2-3 times daily according to the manual from admission day to surgery day (preoperative). They were also advised to promptly inform ward medical staff of any unusual conditions or concerns. 2. Preoperative rehabilitation exercise regimen: * Pulmonary function ex
  • Другое The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services
    1. The navigator's guidance preoperative rehabilitation exercise regimen was identical to that of the control group, but offered full-period guidance, including the following: 1. On the day of admission, in addition to the same measures as the control group, the navigators demonstrated the exercise movements and required participants to perform return demonstrations to ensure mastery of the exercises. 2. During the preoperative period, navigators conducted daily ward visits, offering two

Первичные конечные точки

  • knee osteoarthritis severity [Срок оценки: Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4)]
Вторичные конечные точки (5)
  • Exercise adherence [Срок оценки: Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4)]
  • Self-efficacy [Срок оценки: Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4)]
  • Knee joint function [Срок оценки: Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4)]
  • Knee range of motion (ROM) [Срок оценки: Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4)]
  • Pain intensity [Срок оценки: Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4)]

Критерии участия

Критерии включения

  • Patients diagnosed with knee osteoarthritis (KOA) scheduled to undergo primary unilateral total knee arthroplasty (TKA)
  • Assessed by the attending physician as medically fit to tolerate preoperative rehabilitation exercise, possessing effective communication skills, and capable of cooperating with all required examinations and assessments
  • Assessed as capable (either the patient or their caregiver) of using a smartphone to receive information

Критерии исключения

  • Individuals unable to cooperate due to impaired consciousness, cognitive impairment, or similar conditions
  • Concurrent severe comorbidities such as liver cirrhosis, respiratory failure, renal failure, malignant tumors, trauma, etc.
  • History of significant neuromuscular disorders or other joint diseases deemed by the attending physician to affect joint function
  • a time interval of greater than 7 days or less than 3 days between the admission day date and the scheduled surgery date;
  • Currently undergoing systematic lower limb functional exercise training within the past four weeks

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Китай · 1 центр
  • First Affiliated Hospital of Jinan University — Гуанчжоу

Идентификаторы

NCT: NCT07047079 · KY-2025-105

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗