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

N/AEnrolling By InvitationNCT07047079

Anna Sun84 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Total Knee Arthroplasty Knee Osteoarthritis

Interventions

Autonomous preoperative rehabilitation exercisesOTHER

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

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

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

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 Outcomes

Exercise adherence

The exercise adherence was measured using the Orthopaedic Patient Functional Exercise Compliance Scale, developed by Chinese scholars. This scale comprises three components: adherence to physical exercises (8 items), adherence to psychological exercises (4 items), and adherence to active learning exercises (3 items). Each item is scored using a 5-point Likert scale, where 1 point indicates "not at all able to do it" and 5 points indicate "completely able to do it". Higher scores represent better adherence.

Self-efficacy

Self-efficacy was measured using the Chinese version of the Self-Efficacy for Rehabilitation Outcome Scale.This scale is designed to measure patients' belief in their ability to perform behaviours typical of physical rehabilitation for knee surgery. It comprises two sections, totaling 12 items: Rehabilitation Exercise Self-Efficacy (5 items) and Coping Self-Efficacy (7 items). Each item is rated using an 11-point Likert scale, where 0 indicates "Cannot do at all" and 10 indicates "Can do without any difficulty". The total score is 120. Higher scores indicate stronger rehabilitation self-efficacy beliefs in the patient.

Data from ClinicalTrials.gov

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