Total Knee ArthroplastyNCT07047079
Patient-navigation-based Preoperative Rehabilitation Exercise Program in Patients Undergoing TKA
A study testing Autonomous preoperative rehabilitation exercises and The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services in people with Total Knee Arthroplasty and Knee Osteoarthritis, run by Anna Sun at 1 site in China.
Trial summary
This study aimed to assess the effectiveness of a patient navigation-based preoperative rehabilitation exercise program for patients undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty, Knee Osteoarthritis
- What is being tested?
- Autonomous preoperative rehabilitation exercises and The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
About this study
Official title: The Effectiveness of a Patient-navigation-based Preoperative Rehabilitation Exercise Program in Patients Undergoing Total Knee Arthroplasty: A Randomised Controlled Trial
This study aimed to assess the effectiveness of a patient navigation-based preoperative rehabilitation exercise program for patients undergoing total knee arthroplasty.
Read the 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
- Conditions
- Total Knee Arthroplasty, Knee Osteoarthritis
- Being tested
- Autonomous preoperative rehabilitation exercises, The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services
- Keywords
- Patient navigation, Preoperative exercise, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomous preoperative rehabilitation exercisesOther
- 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.
- 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
- The navigator's guidance preoperative rehabilitation exercise regimen was identical to that of the control group, but offered full-period guidance, including the following:
- 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.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Autonomous preoperative rehabilitation exercise program | Other | Participants will receive an autonomous preoperative rehabilitation program from admission day to surgery day (preoperative). Receives: 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). Receives: Other: The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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°.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start2 Jul 2025
- Primary completion31 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Sun
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University
- Responsible party
- Sponsor-investigator, Anna Sun, First Affiliated Hospital of Jinan University
- Investigators
- Anna Sun, Principal investigator, research team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047079
- Sponsor's protocol ID
- KY-2025-105
- Status last verified
- Sep 2026
- First submitted
- 13 Jun 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Patient-navigation-based Preoperative Rehabilitation Exercise Program in Patients Undergoing Total Knee Arthroplasty: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07047079
- Acronym / sponsor ID
- KY-2025-105
- Conditions
- Total Knee Arthroplasty, Knee Osteoarthritis
- Keywords
- Patient navigation, Preoperative exercise, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Anna SunUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autonomous preoperative rehabilitation exercise program | Other | Other: Autonomous preoperative rehabilitation exercisesParticipants will receive an autonomous preoperative rehabilitation program from admission day to surgery day (preoperative). |
| Patient-navigation-based preoperative rehabilitation exercise program | Other | Other: The navigator provided full-period preoperative rehabilitation exercise guidance+navigation servicesParticipants will receive a patient-navigation-based preoperative rehabilitation exercise programme from admission day to surgery day (preoperative). |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autonomous preoperative rehabilitation exercises1. 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 | Other | Autonomous preoperative rehabilitation exercise program |
| The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services1. 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. | Other | Patient-navigation-based preoperative rehabilitation exercise program |
Primary outcome
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)
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.
5 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Sun principal investigator
research team
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autonomous preoperative rehabilitation exercises and The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services in people with Total Knee Arthroplasty and Knee Osteoarthritis, run by Anna Sun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 1 Nov 2026.