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

NCT ID: NCT07047079

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2026-02-28

Brief Summary

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

Detailed Description

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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

Conditions

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Total Knee Arthroplasty Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Autonomous preoperative rehabilitation exercise program

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

Group Type OTHER

Autonomous preoperative rehabilitation exercises

Intervention Type 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

Patient-navigation-based preoperative rehabilitation exercise program

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

Group Type OTHER

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

Intervention Type 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.

Interventions

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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 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

Intervention Type 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 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital of Jinan University

OTHER

Sponsor Role collaborator

Anna Sun

OTHER

Sponsor Role lead

Responsible Party

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Anna Sun

Nurse Practitioner

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anna Sun

Role: PRINCIPAL_INVESTIGATOR

research team

Locations

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First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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KY-2025-105

Identifier Type: -

Identifier Source: org_study_id

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