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| Name | Class |
|---|---|
| First Affiliated Hospital of Jinan University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autonomous preoperative rehabilitation exercise program | Other | Participants will receive an autonomous preoperative rehabilitation program from admission day to surgery day (preoperative). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autonomous preoperative rehabilitation exercises | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Sun | research team | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | 510630 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2025 |
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| The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services | Other |
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. |
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| 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 | 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. | 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 | Knee joint function will be measured using the Hospital for Special Surgery (HSS) Knee Scoring System. This scale comprises seven sections. This 100-point scoring system includes pain (30 points), function (22 points), range of motion (18 points, one point per eight degrees), muscle strength (10 points), flexion deformity (10 points), and stability (10 points). Points are deducted if patients use walking aids or present with flexion contracture or varus/valgus deformities. Total scores range from 0 to 100, with higher values reflecting superior 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) | Knee range of motion (ROM) will be measured with a goniometer. The normal ROM values for the knee joint are as follows: flexion from 0° to 135°, extension to 0° (with some individuals exhibiting hyperextension ranging from 0° to 10°). The active range of motion (AROM) spans from 0° to 135°, while the passive range of motion (PROM) can reach up to 150°. | 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 | Pain intensity will be measured using the Visual Analogue Scale (VAS). The VAS consists of a 10-centimetre horizontal line divided into 10 equal intervals, where higher scores represent greater pain intensity. A score of 0 denotes no pain, whereas a score of 10 denotes the most severe pain imaginable. Patients are instructed to mark the point on the line corresponding to their perceived 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) |
| Nov 15, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2025 | Nov 15, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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