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

NCT07047079 | Enrolling By Invitation DMC

• 1 other identifier: KY-2025-105
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Total Knee Arthroplasty; Knee Osteoarthritis

Keywords

Patient navigation; Preoperative exercise; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• knee osteoarthritis severity

  Knee osteoarthritis severity will be measured using the Chinese version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scale. The scale consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a scale of 0 to 4. The scores are recoded into a 96-point total scale, where higher scores indicate greater severity of knee osteoarthritis.

  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 Outcomes (5)

• Exercise adherence

  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

  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

  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)

  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

  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)

Study Arms (2)

Autonomous preoperative rehabilitation exercise program

OTHER

Participants will receive an autonomous preoperative rehabilitation program from admission day to surgery day (preoperative).

Other: Autonomous preoperative rehabilitation exercises

Patient-navigation-based preoperative rehabilitation exercise program

OTHER

Participants will receive a patient-navigation-based preoperative rehabilitation exercise programme from admission day to surgery day (preoperative).

Other: The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services

Interventions

Autonomous preoperative rehabilitation exercises OTHER

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 exercises: including abdominal breathing exercises and effective cough learning. * Quadriceps strength exercises: including straight leg raises and lateral leg raises. * Knee range of motion exercises: including knee flexion exercises and knee extension exercises. * Lower limb thrombosis prevention exercises: ankle pump exercise

Autonomous preoperative rehabilitation exercise program

The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services OTHER

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 20-minute supervised sessions and sending nightly exercise reminders between 7:00-8:00 PM. 2. Navigation services covered seven areas: establishing contact with participants or carers, providing disease-related education, assessing needs and facilitating resources, offering social and emotional support, providing interpretation services upon request, identifying and resolving exercise barriers, and promoting self-management.

Patient-navigation-based preoperative rehabilitation exercise program

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anna Sun: lead
• First Affiliated Hospital of Jinan University: collaborator

Study Sites (1)

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Anna Sun

  research team

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse Practitioner

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 2, 2025
• Study Start: July 2, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (1)