The Effectiveness of a Patient-navigation-based Preoperative Rehabilitation Exercise Program in Patients Undergoing Total Knee Arthroplasty: A Randomised Controlled Trial
Phase: NA
Conditions: Total Knee Arthroplasty, Knee Osteoarthritis
Sponsor: Anna Sun

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Research Protocol
Official Title: The effectiveness of a patient-navigation-based
preoperative rehabilitation exercise program in patients
undergoing total knee arthroplasty: a randomised controlled
trial
NCT number: NCT07047079
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Document date: July 2, 2025

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1. Study design
This study is a prospective, single-centre, superiority randomised controlled
trial (RCT) involving two parallel groups. Participants were recruited from
among patients newly admitted to the orthopaedic ward who met the selection
criteria.
2. Participants
A total of 84 participants were consecutively recruited from among patients
newly admitted to the orthopaedic ward who met the selection criteria.
2.1. Participant selection criteria
Inclusion Criteria: (ⅰ) patients diagnosed with knee osteoarthritis who are
undergoing primary unilateral total knee arthroplasty; (ⅱ) aged between 45
and 90 years; (ⅲ) assessed by the attending physician as having sufficient
physical
capacity
to
tolerate
preoperative
rehabilitation
exercises
and
adequate communication skills to cooperate with all examinations and
assessments; and (ⅳ) informed consent was obtained from the patient, and
the signed informed consent form was duly completed.
Exclusion Criteria: (ⅰ) patients who are uncooperative due to impaired
consciousness, cognitive dysfunction, or other factors; (ⅱ) presence of severe
concurrent comorbidities, including liver cirrhosis, respiratory failure, renal
failure, malignancy, or trauma; (ⅲ) a history of significant neuromuscular
disorders or other joint diseases, as determined by the attending physician,
that impair knee joint function; (ⅳ) a time interval of greater than 7 days or less
than 3 days between the admission day date and the scheduled surgery date;
and (ⅴ) patients who have undergone systematic lower limb functional
training within the past four weeks.
2.2. Sample size

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This study used knee osteoarthritis severity as the primary outcome
measure. Given the lack of prior research on the effect of patient navigation
mode on patients' knee osteoarthritis severity. Therefore, the sample size
calculation
for
the
present
study
was
based
on
the
results
of
the
pre-experiment, which showed an effect size of 0.8 on knee osteoarthritis
severity. To achieve a statistical power of 0.80 and an alpha level of 0.05, a
sample size of 33 participants per group is required. Considering a 20%
attrition rate, the total estimated sample size is 84 participants, with 42
participants per group.
3. Randomization and blinding
A non-research team member randomly selected an initial starting point
from a pre-generated computerised random number table. From this point, the
corresponding random numbers were sequentially identified, ranging from 1 to
84. After sorting the random numbers, participants were randomly assigned in
a 1:1 ratio to either Group 1 (the experimental group) or Group 2 (the control
group). Group assignments were concealed within 84 consecutively numbered,
identical, opaque, and sealed envelopes, which the non-research team
member securely kept. On the day of participant enrolment, after completing
demographic and clinical data collection, as well as baseline assessments, the
principal researcher (recruiter) retrieved the envelope corresponding to the
participant’s sequential number from the custodian. The envelope was opened,
and the participant was assigned to the designated group.
Due to the nature of the intervention, the experimental group received
exercise
guidance
from
navigator,
while
the
control
group
did
not.
Consequently, blinding of participants, recruiters, or research intervention staff
was not feasible. However, outcome assessors and data entry analysts will be
blinded. The outcome assessor is an independent research assistant who
remained unaware of the allocation status throughout the study. Before the

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study, the principal researcher (recruiter) trained the outcome assessor. The
outcome assessor independently assessed outcomes and collected data for
both groups from T0 to T4. Moreover, the principal researcher (recruiter)
instructed all participants not to disclose their group assignment to the
outcome assessor. Furthermore, two research assistants, who were not
involved in the study process, served as data entry analysts. The group
assignment was concealed from these analysts by using coded group
identifiers (Group 1 and Group 2) to ensure blinding.
4. Intervention
4.1.Control Group
4.1.1. Summary: Received an autonomous preoperative rehabilitation exercise
programme.
4.1.2. 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
autonomous 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.
4.1.3. Preoperative rehabilitation exercise regimen
A. Exercises for pulmonary function:
a) Abdominal breathing: 10 sets per time, 2-3 times per day.
b) Effective coughing: Practice repeatedly until mastered.
B. Exercises for quadriceps Strength:
a) Straight leg raise: Alternate legs, 10 sets per time, 2-3 times per day.
b) Lateral leg raise: Alternate legs, 10 sets per time, 2-3 times per day.
C. Exercises for the knee range of motion:
a) Knee flexion: Alternate legs, 10 sets per time, 2-3 times per day.
b) Knee extension: Alternate legs, 10 sets per time, 2-3 times per day.

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D. Exercises for preventing lower limb thrombosis:
a) Ankle pump exercise: Both feet simultaneously, 10 sets per time, 2-3
times per day.
4.2. Experimental Group
4.2.1. Summary: Received a patient-navigation-based preoperative
rehabilitation exercise programme
4.2.2. Method: From admission day to surgery day (preoperative), navigator
provided full-period preoperative rehabilitation exercise guidance and
navigation services aimed at promoting rehabilitation exercise.
A. The navigator provided full-period preoperative rehabilitation exercise
guidance, which displayed as follows: (The preoperative rehabilitation
exercise regimen guided by the navigator was the same as that of the
control group.)
a) On the day of admission, in addition to explaining the
preoperative exercise regimen and distributing a guidance manual as
done for the control group, the navigator demonstrated the exercise
movements and required participants to
perform return demonstrations to ensure mastery of the exercises.
b) During the preoperative period, navigators conducted daily ward visits
to provide face-to-face exercise guidance, including two 20-minute
supervised sessions per day, and sent exercise reminder text messages
every night from 7:00 PM to 8:00 PM.
B. The navigation services aimed at promoting rehabilitation exercise
encompassed the following seven themes: On the day of admission, (ⅰ)
establish contact with participants or their carers, and (ⅱ) provide
disease-related education. During the preoperative exercise period, (ⅲ)
assess participant needs and facilitate access to resources; (ⅳ) offer
social and emotional support; (ⅴ) provide verbal interpretation services

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available upon request; (ⅵ) identify and address barriers to exercise
implementation; and (ⅶ) support participants’ self-management.
(ⅰ) Establish contact with participants or their carers: On the day of
admission, the navigator will add the participant's or their carer's
contact details and inform them that they may consult the navigator
via these contact details should they have any queries or
requirements during the preoperative rehabilitation exercise period.
(ⅱ) Provide disease-related education：
1 Knee Osteoarthritis Information: Including the definition of
osteoarthritis,
the development of knee osteoarthritis, and the
grading of knee osteoarthritis.
2 Total Knee Arthroplasty Surgery Information: Surgical method and
benefits of the surgery.
3 Perioperative care guidance: Including preoperative daily life
precautions, management of perioperative pain, respiratory care,
postoperative lower limb thrombosis prevention, and preparation
of surgical supplies.
(ⅲ) Assess participant needs and facilitate access to resources:
1 Needs assessment: Navigators will understand participants' illness
conditions, prior treatment histories, and current physical states
and will discuss expectations regarding the surgery with
participants, which includes pain management, functional recovery,
and quality-of-life improvements, alongside anticipated
post-operative rehabilitation requirements such as physiotherapy,
independence in activities of daily living, and care support.
2 Resource linkage: Based on the needs assessment, the navigator

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will introduce available hospital resources to participants, such as
rehabilitation and pain management teams, the hospital's
psychological counseling centre, and continuing care services.
3 Information provision and assistance: The navigator will explain
the surgical procedure, post-operative precautions, and expected
recovery timeline in detail according to the participant's needs,
ensuring they understand each step. Information on hospital
companion services will be provided, including details of
companions, contact information, service content, and fees. Offer
medical insurance reimbursement details, with navigators
explaining coverage scope, claim procedures, and consultation
channels for different insurance schemes. Additionally,navigators
will assist with scheduling appointments for specialised
examinations or treatments.
4 Reminder services: Navigators will provide reminders for
scheduled preoperative examinations, including advance
notification of any special requirements (e.g., fasting, holding
urine). Navigators will also offer weather-related reminders and
guidance as appropriate.
(ⅳ) Offer social and emotional support：
1
Provide encouragement and support: During preoperative
rehabilitation exercises, navigators offer positive feedback and
encouragement to help participants build confidence and
overcome psychological barriers. Sharing video testimonials of
successful recovery cases inspires participants' motivation to
exercise; using quantifiable metrics (such as scales) to document
progress enables participants to perceive the effects of
rehabilitation.
2
Provide psychological counseling: Should participants exhibit
negative emotions such as anxiety or depression, navigators

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promptly offer psychological support, providing effective coping
strategies and encouraging participants to express their feelings
to aid emotional regulation.
3
Encourage family or carer involvement: Encourage family
members or carers to actively join in the participant's rehabilitation
exercises and active communication with participants, and jointly
provide support and reassurance to participants.
(ⅴ) Provide verbal interpretation services available upon reques:
navigators can provide participants with verbal interpretation services
in Cantonese, Mandarin, and Teochew.
(ⅵ) Identify and address barriers to exercise implementation:
1 Lack of interest or motivation in exercise: Explain the purpose and
benefits of preoperative rehabilitation exercises; actively share
success stories of preoperative rehabilitation exercises; provide
positive feedback and encouragement.
2 Negative emotional impact: Offer timely psychological counseling,
encourage participants to express their feelings, and assist in
emotional regulation; teach participants relaxation techniques (such
as meditation and deep breathing) to alleviate stress; and
encourage mutual support and communication among participants.
3 Failure to perceive anticipated outcomes: Utilise quantifiable knee
metrics (e.g., knee function scales, pain scales, etc.) to document
participant progress; conduct daily exercise progress reviews with
participants and adjust preoperative rehabilitation programmes
based on feedback.
4 Fear of pain: Inform participants about normal pain thresholds
during rehabilitation exercises and provide pain relief strategies;
guide participants to perform preoperative rehabilitation exercises at
an intensity tolerable to them; Inform participants that a
rehabilitation navigator will provide ongoing guidance in the ward.

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5 Limitations due to comorbidities: Measures as per (ⅶ)②below.
6 Insufficient family and carer support: Measures as per (ⅳ)③above.
7 Weather impediments: Provide participants with considerate
reminders and rehabilitation exercise guidance based on weather
conditions.
(ⅶ) Support participants’ self-management:
1
Perioperative safety guidance: Inform participants of safety
precautions when using walking aids, fall prevention measures,
and safety considerations for using medical facilities and
equipment.
2
Guidance for participants with underlying conditions: Upon
admission, navigators conduct detailed assessments of
participants' underlying conditions, collaborating with the medical
team to develop personalised management plans. Participants
receive instruction on monitoring relevant indicators and operating
associated devices, adhering to medication schedules as
prescribed, managing daily lifestyle factors (diet, exercise, weight
control), and recognising and handling emergencies or abnormal
symptoms.
3
Postoperative self-management guidance for TKA:
• Wound care: Explain dressing change schedules, precautions
during dressing changes, and wound dressing observation.
• Complication prevention: Instruct on preventing postoperative
wound infections, deep vein thrombosis, and constipation.
• Postoperative life precautions: Inform on prohibited movements,
allowed actions, and mobility techniques.
5. Data collection
Data collection will be conducted at five time points: on admission day
(baseline, T0), surgery day (preoperative) (T1), one week post-surgery (T2),

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two weeks post-surgery (T3), and four weeks post-surgery (T4). The collected
study data will include demographic and clinical information collected by the
principal investigator (recruiter), as well as outcome measures collected by
assessors from T0 through T4. These outcome indicators encompass knee
osteoarthritis severity, exercise adherence, self-efficacy, knee joint function,
knee range of motion, and pain intensity.
6. Outcome assessment
6.1. Primary outcome
The primary outcome is the change in knee osteoarthritis severity from
admission day (baseline, T0) to surgery day (preoperative) (T1). As the
intervention in this study aims to enhance patient adherence to preoperative
rehabilitation exercises, the ultimate objective is to improve their rehabilitation
outcomes. Therefore, the change in knee osteoarthritis severity from T0 to T1
in both groups of participants will be used to evaluate the effectiveness of the
intervention.
Knee osteoarthritis severity will be measured using the Chinese version of
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Scale, which is a self-administered instrument specifically developed to assess
the severity of knee osteoarthritis and the efficacy of related treatments
(Bellamy et al., 1988). The scale consists of 24 items divided into three
subscales: pain (5 items), stiffness (2 items), and physical function (17 items).
Several scoring methods have been developed for the Western Ontario and
McMaster Universities Osteoarthritis Index Scale items (Noyes, 2016). In this
study, a 5-point Likert scale is employed, where 0 represents “no difficulty” and
4 represents “extreme difficulty”. The total score ranges from 0 to 96, with
higher scores reflecting more severe knee osteoarthritis.
6.2. Secondary outcomes

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The secondary outcomes are changes from baseline in exercise adherence,
self-efficacy, knee joint function, knee range of motion, and pain intensity at T1,
T2, T3, and T4, as well as changes from baseline in knee osteoarthritis
severity at T2, T3, and T4.
Exercise adherence will be measured using the Orthopaedic Patient
Functional Exercise Compliance Scale developed by Chinese scholars (Tan et
al., 2019). This instrument effectively assesses rehabilitation adherence
among
orthopaedic
patients.
It
consists
of
15
items
covering
three
dimensions—physical exercise adherence, psychological exercise adherence,
and active learning exercise adherence—with patients rating their ability to
perform each activity. Each item is rated on a five-point Likert scale ranging
from 1 (“Not at all possible”) to 5 (“Completely possible”). Total scores range
from 15 to 75, with higher scores reflecting greater adherence to rehabilitation
exercises.
Self-efficacy will be measured using the Chinese version of the Self-Efficacy
for
Rehabilitation
Scale
(SER)
(Wang
et
al.,
2014).
This
scale
has
demonstrated
strong
reliability
and
validity
in
assessing
rehabilitation
self-efficacy among patients undergoing knee replacement. The Chinese
version
of
the
Self-Efficacy
for
Rehabilitation
Scale
includes
two
dimensions—Rehabilitation Self-Efficacy (five items) and Coping Self-Efficacy
(seven items)—for a total of 12 items. Each item is rated on an 11-point Likert
scale ranging from 0 (“Not at all”) to 10 (“No difficulty whatsoever”), yielding a
maximum total score of 120. Higher scores denote greater rehabilitation
self-efficacy.
Knee joint function will be measured using the Hospital for Special Surgery
(HSS) Knee Scoring System (Weitzel et al., 2002). 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

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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.
Knee range of motion (ROM) will be measured with a goniometer. ROM
measurement assesses knee movement amplitude, serving as a critical
indicator of knee joint function and a key indicator for evaluating rehabilitation
outcomes following total knee arthroplasty. Normal knee range of motion
values are as follows: flexion, 0°–135°; extension, 0° (some individuals may
exhibit hyperextension of 0°–10°); active range, 0°–135°; and passive range,
up to 150°.
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.
7. Statistical analysis
IBM® SPSS Statistics 27.0 will be used to analyse the data from all
randomised participants.
Statistical significance was
set
at p
≤
0.05.
Categorical variables (e.g., gender, marital status, payment type) appeared as
frequencies and percentages. Continuous variables (e.g., age, height, weight)
appeared as mean ± standard deviation (SD). Continuous data meeting the
assumptions of normality and homogeneity of variance were analysed using
independent-sample
t-tests;
otherwise,
the
Wilcoxon
signed-rank
test
appeared. Categorical data were analysed using the chi-square test or
Fisher’s exact test for intergroup comparisons. Generalised Estimating

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Equations (GEE) were employed to compare longitudinal changes in outcome
variables between groups, with statistical significance set at p < 0.05
(two-tailed). The GEE was chosen as it accounts for within-subject correlations
inherent in repeated measures, thereby improving the efficiency of parameter
estimation in longitudinal analyses. Moreover, the GEE approach flexibly
accommodates missing data. When the proportion of missing data was below
5%, the GEE inherently accommodated the missing values; otherwise, multiple
imputation procedures were applied.
8. Trial monitoring
The Clinical Research Management Department and the Ethics Committee
of the study-conducting hospital will oversee trial implementation and ensure
compliance with ethical standards. The principal researcher is required to
submit regular progress reports and interim results to the Clinical Research
Management Department and the Ethics Committee of the study-conducting
hospital. They will review the completeness, accuracy, and timeliness of data
collection, as well as procedures related to participant enrolment, informed
consent, eligibility assessment, and protocol adherence. Based on the findings
of interim reports and a comprehensive evaluation of the study’s efficacy,
safety, and feasibility, they will make the final determination regarding whether
the trial should be terminated.
9. Ethical
9.1. Research ethical approval and informed consent
This study adheres to the ethical principles outlined in the Declaration of
Helsinki and has received approval from the Ethics Committee of the research
implementation hospital (No. KY-2025-105). All participants will receive written
information detailing the study objectives, procedures, potential risks, and
benefits. Participation in the study is entirely voluntary, and participants may

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withdraw at any time without providing a reason or facing any consequences.
Each participant must sign a written informed consent form before enrolment.
Participants will withdraw from the study under the following circumstances:
withdrawal of consent, loss to follow-up, receipt of unapproved rehabilitation or
treatment during the study period, or a clinician’s determination that the
participant is unsuitable to continue, such as in cases of serious adverse
events or serious complications.
9.2. Confidentiality
The results of this study may be published in medical journals. However, all
members of the research team will maintain participants' confidentiality in
accordance with legal requirements. Personal information will not be disclosed
unless required by pertinent legal or regulatory mandates. All case report
forms were securely stored in a locked cabinet located in the principal
researcher’s office, and the principal researcher retained sole custody of the
key. Participant identities were anonymised using a sequential number to
protect confidentiality. The trial data collected will only be accessible to
authorised members of the research team during the study.