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Enrolling by invitation NCT07047079

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

No phase Interventional Total Knee Arthroplasty Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autonomous preoperative rehabilitation exercises, The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services.
Who it may be relevant to
Registry conditions: Total Knee Arthroplasty, Knee Osteoarthritis. Basic parameters: 45 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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

Interventions

  • Other 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
  • Other 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

Primary outcome measures

  • knee osteoarthritis severity [Time frame: 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)]
Secondary outcome measures (5)
  • Exercise adherence [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

China · 1 center
  • First Affiliated Hospital of Jinan University — Guangzhou

Identifiers

NCT: NCT07047079 · KY-2025-105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗