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Abstract
Introduction Knee osteoarthritis (KOA) is still a challenging degenerative joint disease with high morbidity and disease burden. Early-stage KOA, the focus of this study, could present a Window of Opportunity to arrest the disease process and reduce the disease burden. Yijinjing exercise is an important part of physical and psychological therapies in Traditional Chinese Exercise and may be an effective treatment. However, there is no clinical efficacy assessment of Yijinjing exercise for patients with early-stage KOA. Therefore, we designed a randomised controlled trial to evaluate the effectiveness of Yijinjing exercise on patients with early-stage KOA.
Methods and analysis This is a parallel-design, two-arm, analyst assessor-blinded, randomised controlled trial. In total, 60 patients with early-stage KOA will be recruited and randomly assigned to the Yijinjing exercise group (n=30) and health education group (n=30) at a ratio of 1:1, receiving 12 weeks of Yijinjing exercise or health education accordingly. The primary outcome will be measured with the Western Ontario and McMaster Universities Osteoarthritis Index, and the secondary outcomes will include the Visual Analogue Scale, Short-Form 36 Item Health Survey Questionnaire, Beck Depression Inventory, Perceived Stress Scale, Berg Balance Scale, and Gait Analysis for a comprehensive assessment. Outcome measures are collected at baseline, at 12 week ending intervention and at the 12 week, 24 week and 48 week ending follow-up. The primay time point will be 12 weeks postintervention. Adverse events will be recorded for safety assessment.
Ethics and dissemination This study has been approved by the ethical application of the Shanghai Municipal Hospital of Traditional Chinese Medicine Ethics Committee (2021SHL-KY-78).
Trial registration number ChiCTR2200065178
- COMPLEMENTARY MEDICINE
- Knee
- Musculoskeletal disorders
- SPORTS MEDICINE
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STRENGTHS AND LIMITATIONS OF THIS STUDY
To the best of our knowledge, this study will be the first randomised controlled trial to explore the effectiveness of Yijinjing exercise in the treatment of early-stage knee osteoarthritis (KOA) patients.
This study will evaluate pain intensity, stiffness, and physical function, life quality, psychological health, and knee function, which will support the clinical efficacy of Yijinjing exercise in early-stage KOA patients.
This study will use gait analysis to evaluate the kinetic and kinematic function of patients with early-stage KOA.
Due to the specific nature of exercise interventions, it is difficult to ensure that participants and instructors are blinded.
Introduction
Knee osteoarthritis (KOA) has become a major public health challenge globally1 that requires proper disease management for the early stage to arrest the disease process. KOA is characterised by chronic pain and disability with a high global prevalence.2 The prevalence of KOA is increasing in younger age group of 35–55.3–5 KOA affects more than 260 million people worldwide,6 increasing by 9.3% from 1990 to 2017,1 and the prevalence may continue to increase.7 Relatively advanced KOA can cause irreversible structural damage to the joints.8 And KOA ranks as the 11th highest contributor to the global disability, seriously damaging the patient’s quality of life.9 10 Early-stage KOA, as a possible Window of Opportunity to prevent the disease process and improve the quality of life, should be given enough attention.11 12
Proper management of early-stage KOA13 14 could arrest the disease process, restore joint homeostasis, and thereby reduce the burden of disease.11 Early-stage KOA is a type of KOA that is symptom-focused for diagnosis.11 15 Patients present primarily with pain and discomfort in the knee joint. The symptoms are episodic and may persist for weeks. Pharmacological treatment can reduce pain and improve physical function in patients with KOA.16 However, the long-term pharmacological treatment may have adverse effects,17–19 causing enormous economic pressure and reducing quality of life.20–22
Targeted and appropriate exercise may be an effective treatment for early-stage KOA. Exercise therapy is widely used in KOA treatment to improve muscle strength and functional activity.8 23 24 Previous studies show that Traditional Chinese Exercise (TCE) can alleviate pain and improve functions.25–28 Yijinjing exercise, as an important part of physical and psychological therapies in TCE, has been widely used to treat neck pain,29–33 ankylosing spondylitis34 and sequelae of stroke,35–38 which can improve the muscle strength39 40 and knee function,41 42 and relieve knee pain and psychological stress.33 43 44
However, clinical evidence for the efficacy of Yijinjing exercise in patients with early-stage KOA is still lacking. To the best of our knowledge, this randomised controlled trial is the first study to evaluate the effectiveness in early-stage KOA patients treated by Yijinjing exercise. Furthermore, this study is based on in-depth research from previous studies, as the subjects of this study are limited to early-stage KOA patients and have optimised Yijinjing exercise programme for early-stage KOA patients.44 For patients with early-stage KOA, we claim that Yijinjing exercise to be superior to health education strategy of the non-surgical management of KOA in pain relief and function improvement after a 12 week intervention.
Methods and analysis
Study design
The study will be a randomised, single-centre, superiority, parallel controlled trial. Only outcome assessors and statisticians will be blinded due to the limitations of the intervention methodology. A total of 60 patients with early-stage KOA will be recruited from the Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine. All patients will be provided with written informed consent at the time of recruitment. The patients will have equal opportunity to be assigned to Yijinjing exercise group and health education group in a 1:1 allocation ratio. Patients in the Yijinjing exercise group and the health education group will receive 12 weeks of Yijinjing exercise and health education, respectively. Data management and statistics will be conducted at the School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine. The study process is shown in figure 1. The planned start and end dates for the study are 30 February 2024 to 30 February 2026.
CONSORT flow chart of the study. CONSORT, Consolidated Standards of Reporting Trials.
The present study is a randomised controlled trial. During the treatment, patients in the Yijinjing exercise group will practice Yijinjing exercise, while the health education group will receive health education. Both the outcome assessments will be performed at five time points, namely the baseline, the end of the treatments at 12 weeks, and 12, 24, and 48 weeks of follow-up subsequently. The schedule of enrolment, interventions, and assessments is shown in table 1.
The schedule of enrolment, interventions, and assessments
Study setting
The study will be conducted at the Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, China.
Safety measurements
Safety evaluations will be conducted at screening, throughout the trial, and at follow-up 12, 24, and 48 weeks after the last Yijinjing exercise. The safety evaluations will be initially conducted by the attending physician with more than 5 years of work experience, followed by a final review by a chief physician with more than 15 years of work experience. The initial assessors will receive a series of training on expertise and risk assessment from our research team and pass the training examination before formally implementing the safety assessment during the study. Any adverse events (AEs) will be collated from case report forms and follow-up questionnaires even though Yijinjing exercise and health education are at low risk. Researchers will then analyse whether AEs are directly related to the rehabilitation programme. When sports injuries occur or condition suddenly deteriorates during the trial with serious complications or severe AEs such as breathing difficulties, sports injuries and falls, the trial will be terminated immediately and prompt medical treatment will be administered according to the condition of the subject. Researchers will then analyse whether they are directly related to the rehabilitation programme. Serious AEs will be reported to the Shanghai Municipal Hospital of Traditional Chinese Medicine Ethics Committee in a timely manner.
Sample size calculation
Power analysis is based on published data regarding to changes in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score in an open trial45 concerning TCE treatment in KOA. The difference in the reduction in WOMAC scores between the TCE treatment group and the control group in previous studies was 4.22. The SD in the TCE treatment and the control group were 5.15 and 3.24, respectively. Suppose α=0.05, a power level of 0.9 and a 20% rate dropout, a total of 60 participants was calculated by the PASS software (PASS 15, NCSS, LLC, Kaysville, UT, USA).
Inclusion and exclusion criteria
Inclusion criteria
KOA diagnosis according to criteria listed in the Chinese guideline for the diagnosis and treatment of osteoarthritis (2021 edition).23
Kellgren‒Lawrence score≤2.46 47
Pain level≥3 on the 10-point Visual Analogue Scale (VAS).
Man or woman aged 35–65 years.
Ability to perform basic body movements like walking.
No communication barriers with researchers to understand the instructions.
Body mass index≤36 kg/m2.
Willingness to participate and sign the informed consent form.
Exclusion criteria
Physical or mental illness that seriously interferes with daily life or contraindicates exercise.
The Montreal Cognitive Assessment cognitive status evaluation score≤24.48
Inability to independently complete gait analysis.
Knee surgery or intra-articular injections within 3 months.
Yijinjing or other clinical exercises in the last 3 months.
Other reasons considered necessary by the researchers, such as communication barrier due to inability to speak Chinese; surgery is planned within the next 12 weeks; inability to commit to the Yijinjing exercise requirements.
Drop-out criteria
Inability to continue owing to serious medical conditions.
Voluntary withdrawal.
Recruitment
Patients with early-stage KOA will be recruited. In our study, participants will be recruited from Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine. Recruitment methods included WeChat networking, online advertisements, doctor referrals, posters, and leaflets. WeChat is currently considered the most popular social media in China. Both medical staff and patients have their own WeChat accounts for convenient and fast online communication. Shanghai Municipal Hospital of Traditional Chinese Medicine is a tertiary hospital in Shanghai, with an outpatient department for the treatment of Yijinjing exercise. Before the trial, participants will be briefed on the study process and their responsibilities. They will be informed about the examination items and precautions. Participants will be informed that their participation is entirely voluntary, and they could refuse or withdraw at any time without affecting their medical or other benefits. Written informed consent will be obtained prior to the commencement of any study-related treatments. Research assistants will be responsible for obtaining informed consent.
Randomisation and allocation concealment
Sixty eligible subjects will be randomly assigned to Yijinjing exercise group and health education group at a 1:1 equal ratio after baseline assessment. The random list will be generated by a statistician using the computer programme (Strategic Applications Software). An independent assistant will then make sequentially numbered, sealed and opaque random envelopes that will contain the corresponding random numbers and intervention methods. Envelopes will be sealed and stored before use, and then distributed to the patients by researchers to determine patient groupings.
Blinding
Due to the specific nature of exercise interventions, it is difficult to blind the participants and researchers. However, outcome assessors and statisticians will be blinded in this study. They will only be responsible for the results analysis and data collection. The recruitment and assignment information will be hidden from the assessors to ensure the accuracy and reliability of the results. There will be no unblinding at any point.
Intervention
Yijinjing exercise group
The participants in Yijinjing exercise group will receive 12 weeks of Yijinjing exercise intervention. They will be taught by experienced professional Yijinjing exercise instructors (clinical experience in Yijinjing exercise therapy≥10 years, with the teacher qualification certificate of higher education). Before conducting trials, the instructor must go through meticulous clinical trial training and cannot implement an intervention until they pass an examination. The course includes the instruction of six movements, involving details such as the breathing rate, meditation method, knee flexion, and extension rotation angle. The specific exercise content refers to the health qigong compiled by the General Administration of Sport of China,49 the specific action characteristics of which are shown in table 2 and figure 2. In the first week, the instructor will lead participants through the entire process and introduce the details of each movement, and encourage them to discuss their feelings and confusions following the exercise to ensure that every participant could practice Yijinjing exercise correctly. After the initial week of exercise, participants will continue with home-based exercises. To ensure adherence to correct exercise methodologies, ongoing support and supervision will be provided by the instructors through video conferences. The intervention frequency will be 30 min twice a week, preceded by a 5 min warm-up and followed by a 5 min relaxation. Training intensity will be assessed using the modified Borg Fatigue Rating Scale (score≥5).44 50 The scale ranges from 0 to 10, where 0 indicates no exertion at all and 10 represents maximal exertion. This method provides a nuanced understanding of the participant’s perceived exertion during the Yijinjing exercises. After Yijinjing exercises, participants are asked to rate their level of fatigue using this scale. The score ≥5 is qualified. Otherwise, the training intensity of Yijinjing exercise will be increased to qualified, and the increased training intensity and training duration will be recorded.
Demonstration of Yijinjing exercise. (A) Action 1, (B) Action 2, (C) Action 3, (D) Action 4, (E) Action 5, and (F) Action 6.
Details of the operation of Yijinjing exercise
Health education group
The participants in health education group will receive 12 weeks of group-based KOA-related health education by instructors, a non-surgical management strategy recommended by the guideline.16 The instructors providing the health education are professors from Shanghai University of Traditional Chinese Medicine with over 10 years of experience in treating KOA. The 40 min educational session will be organised twice a week, with face-to-face instruction the first week and then transition to video conferencing. The session will be based on relevant KOA guidelines and results from recent discoveries.10 23 24 51 52 The session will include the following: (1) the basic concept of KOA, (2) risk factors associated with KOA, (3) KOA prevention and management, (4) self-care strategies, and ways to improve the quality of life (such as lifestyle changes to relieve pain).
The intervention will last for 12 weeks in both groups, and then both groups will be followed up for another 48 weeks. Participants in both group will be reminded weekly not to practice other clinical exercises, and if they do, they will be recorded. To ensure compliance, both groups will not be prohibited from using medication. However, medication is only allowed when the VAS score is ≥3. Only the prescribed dose of celecoxib capsules will be used. Patients who use medication when the VAS is still ≤3 or overuse the medication will be considered as drop-out. The frequency of medication will be observed and recorded.
Adherence
Participants will be encouraged and supervised to receive the intervention by telephone each week and will be asked to fill out weekly charts. And participants will be provided with remote video supervision during the intervention and asked to sign a recording form after the intervention. For Yijinjing exercise group, the study will calculate adherence as the percentage of the 24 scheduled Yijinjing exercise sessions completed. For health education group, the study will calculate adherence as the percentage of the 24 scheduled sessions completed.
Outcome measurements and follow-up
This study will test the outcome indicators at five time points: baseline, the end of 12 week intervention, and the end of the 12 week, 24 week, and 48 week follow-up. The primary indicator will be the WOMAC score. The secondary indicators include VAS, Short-Form 36 Item Health Survey Questionnaire (SF-36), Beck Depression Inventory (BDI), Perceived Stress Scale (PSS), Berg Balance Scale (BBS), and Gait Analysis. After the end of the trial, the mean and SD of the two sets of each outcome indicators will be combined with the corresponding formula to test the power of the trial and judge the reliability of the trial results. The primary time point will be 12 weeks postintervention. The secondary time point will be 12, 24, and 48 weeks after follow-up.
Basic information
Participants’ sociodemographic data (including age, gender, height, weight, blood pressure, occupation, educational background, employment status, and residential area) and medical history (including the date of diagnosis, duration of KOA, and previous treatments for KOA) will be assessed at baseline.
Primary outcomes
The WOMAC is an internationally recognised lower limb assessment method, widely used in the clinical assessment of KOA symptoms with high reliability and validity in Chinese KOA patients.53 54 The WOMAC consists of three main areas: pain, stiffness, and joint function, to assess the structural and functional status of the knee.55 The WOMAC consists of three subscales, including pain (20 points), stiffness (8 points), and daily functional activities (68 points), with a total score of 0‒96. A higher total score indicates a higher level of knee dysfunction; a lower total score indicates a better functional status of the knee joint. The total score of the WOMAC scale will be used to assess the clinical efficacy of Yijinjing exercise in patients with KOA.56 The primary outcome will be assessed in both the Yijinjing exercise group and the health education group.
Secondary outcomes
Secondary outcomes will assess the clinical impact of Yijinjing exercise and health education on the pain level, life quality, psychological health, and knee function in patients with early-stage KOA. Measurements include VAS, SF-36, BDI, PSS, BBS, and Gait Analysis.
Visual Analogue Scale (VAS)
The VAS is a sequence of 10 cm numbers, one of the most commonly used scales to assess pain.57 The left side corresponds to level 0, indicating no pain, while the right side corresponds to level 10, indicating the most severe pain. Patients can mark their pain level in this segment. From the left side to the right side, the higher the number, the higher the pain score.58 It will be by paper in using the VAS to avoid adverse effects on the VAS assessment when using different models of tablets.
Short-Form 36 Item Health Survey Questionnaire (SF-36)
The quality of life will be measured by the SF-36. The SF-36 consists of 36 items assessing eight health concepts: basic competence (10 items), physical activity (four items), social activities (two items), physical pain (two items), mental health (five items), daily activities (four items), vitality (four items), and general health status (five items). Each health concept is scored from 0 to 100, with 0 corresponding to the worst health condition and 100 for the best health condition. The higher the score, the better the health status. The SF-36 has high reliability and validity in the Chinese population.53 59 60
Beck Depression Inventory (BDI)
The BDI is a self-rating scale to determine the degree of depression. The scale is divided into 21 items, including depression, pessimism, and self-disappointment. Each item is scored on a 0, 1, 2, or 3 scale and the cumulative score for each item is the total score. The total score range for the BDI is 0–39, the higher the score, the more severe the depression.61 The BDI is one of the most commonly used self-rating scales for depression and a classic tool for depressive state, screening with internal consistency and validity in non-psychiatric patient populations.59 62 63
Perceived Stress Scale (PSS)
The PSS is a self-assessment tool for measuring the severity of stress and can detect overall and prevalent stress in life.64–66 The PSS contains 10 items, each rated on a 5-point Likert scale, with 0 meaning never, 1 meaning occasionally, 2 meaning sometimes, 3 meaning often, and 4 meaning always. The total score is 0 to 40, with higher score associated with higher level of perceived stress, with 0–13 indicating low-pressure levels, 14–19 indicating medium pressure levels, and >19 indicating high-pressure levels.
Berg Balance Scale (BBS)
The BBS is a comprehensive scale that measures balance and assesses a patient’s balance function by evaluating performance on 14 functional tasks.67 68 The balance function is divided into 14 items, from easy to difficult, and each item is divided into 5 levels; 0, 1, 2, 3, and 4. The maximum score is 4, and the minimum score is 0. The maximum total score is 56, and the minimum score is 0. A higher total score indicates a relatively better balance in the patient.
Gait analysis
Gait analysis is an examination method to study walking patterns, which can be used in the kinematics and kinetics of the lower limbs of patients with KOA, guiding rehabilitation assessment and treatment, contributing to clinical diagnosis, efficacy assessment, and mechanistic studies.69 70 The test procedures are as follows: (1) participants will be asked to walk on a 10 m pavement with three one-way walking tasks per test. (2) 3D marker trajectories will be recorded at 100 Hz using a Vicon16 camera MX13+motion system (Vicon, Oxford Indicators, UK). (3) A total of 28 marker points will be affixed for body surface marking based on the anatomical locations specified by the pyCGM2-LowerLimbCGM23 model. (4) 3D kinematic data will be collected with two force platforms (1200 Hz, Advanced 130 Mechanical Technologies, Watertown, MA, USA) using the Vicon Nexus software (Vicon Motion Analysis, Oxford, UK).71 72
Data collection and management
Each researcher will receive unified training, such as study requirements, standardised measurements of height, weight, and blood pressure, ensuring that they can collect indicators in a uniform, standard manner. All indicators will be collected peer-to-peer by members in charge of recruitment, the members will inform all participants and obtain their support during recruitment. Participants will be followed throughout intervention to prevent shedding.
All researchers will maintain the confidentiality of all participants’ personal information and indicator results. Two members accountable for data will enter all collected data into the computer using a double-data entry method. Data cleaning will be performed before data analysis to prevent discrepancies or coding errors. The electronic data will be checked against the paper records of the original data. Furthermore, the data entered will then be double-checked for accuracy by two other members. Finally, all electronic data will be stored in a zip folder using a password-protected access system, and hard copies of all material will be stored in a specific cabinet.73 Data will be periodically audited and verified internally. Data monitoring will be conducted by the Science and Technology Department of Acupuncture and Tuina Institute, Shanghai University of Traditional Chinese Medicine. The monitors will verify that all AEs are recorded in the correct format and as defined by the protocol. The monitors will verify the following variables for all participants: initials, date of birth, gender, signed informed consent, eligibility criteria, date of randomisation, treatment assignment, AEs, and endpoints. The administrators will be required to report weekly data monitoring progress to the Steering Committee regularly, including the accuracy and reliability of data.
Data analysis
All data processing and statistical analyses will be performed by SPSS statistical software V.26.0 (IBM), conducted by independent data assessors who are unaware of the group allocation. Missing data will be replaced according to the principle of the last observation carried forward. For the missing data, several sensitivity analyses will be conducted to evaluate their effects on the results of the experiment. An intention-to-treat analysis will be applied to all the outcomes. For example, non-adherent participants will be included for intention-to-treat analysis. A sensitivity will be then conducted to test if it alters the results. The Shapiro‒Wilk test will be used to determine the normality of the primary outcome and all other secondary outcomes data, and then to obtain means, SD, maxima, minima, medians, CIs, and frequencies (composition ratios). For continuous outcome measures, analysis of variance will be used to adjust baseline outcome values to compare the difference in mean change between the two groups (follow-up minus baseline).59 The results will be expressed as estimated differences with 95% CI. Log-binomial regression will be used to compare the likelihood of improvement in pain and function between the two groups. Results will be expressed as a relative risk at 95% CI. Multifactorial analysis will be used to adjust for confounders. Statistical significance is demonstrated by a p-value (bilateral) of less than 0.05. For participants with bilaterally KOA, we will use multiple statistical analysis strategies. For example, we will record the number of left or right knees in all participants who meet the inclusion criteria, and statistically analyse the changes in VAS pain for all knee joints by Yijinjing exercise. At the same time, we will conduct subgroup analysis of participants with single knee pain to explore the changes of VAS pain of participants with single knee pain induced by Yijinjing exercise. In addition, we will conduct a subgroup analysis of participants with bilateral knee pain to explore the changes of VAS pain in participants with bilateral knee pain by Yijinjing exercise.
Discussion
Increasing attention is paid to the early-stage KOA14 74–76 because articular cartilage can still regenerate, while articular cartilage may be permanently lost in the advanced stage.15 77 Due to the limited benefits of pharmacologic therapy and surgery, non-pharmacologic therapy has gradually gained attention in managing KOA.78 Non-pharmacological approaches, such as exercise, weight loss, and healthy diet are strongly recommended in managing KOA.21 Exercise has the benefits of muscle strengthening and hypertrophy, weight management, and potential disease-modifying effects.79–81 Traditional exercise training focuses on improving muscle strength, which is critical to the mobility of KOA patients. Recently, growing evidences have advocated the potential benefits of TCE on symptomatic improvement of KOA.82 We have previously launched the clinical application of Taiji in elderly people with KOA.45 83 84 Yijinjing exercise, a kind of TCE that combines physical activity, mental focus, and controlled breathing, is easier to learn and promote than Taijiquan studies.85 86 However, the evidence and mechanism for the effect of Yijinjing exercise on early-stage KOA are still insufficient.87
To the best of our knowledge, this is the first study that explores the effects of Yijinjing exercise for early-stage KOA. Previous studies on Yijinjing exercise for KOA have been published, but the effectiveness of early-stage KOA patients is still unclear.41 88–91 The prior research of our group44 has confirmed that Yijinjing exercise therapy could improve the walking speed and restore the trend of normal gait of KOA and appeared be associated with improvements in psychological well-being including reduced stress, anxiety, depression, and mood disturbance to manage KOA. In contrast to end-stage KOA, structural alterations in joint tissues at an earlier stage may be more susceptible to disease-modifying interventions, potentially slowing or preventing progressive change.92
Our study has some strengths. First, this trial will explore the effectiveness of Yijinjing exercise in the treatment of early-stage KOA in a comprehensive scale. Regardless of structural changes, multiple patient-reported outcomes must be evaluated to reflect clinically meaningful changes better. This study will evaluate pain intensity, stiffness, and physical function, life quality, psychological health, and knee function, which will support the clinical efficacy of Yijinjing exercise in early-stage KOA patients. The pathological changes are usually presented throughout the gait motion and are often difficult or incomplete to induce symptoms on static examination.93 94 Gait analysis can allow the discrimination of KOA patients from asymptomatic participants and can also differentiate KOA patients with low KL grade (KL 1–2) from high KL grade (KL 3–4) with a high success rate.95 Besides, the follow-up time for early-stage KOA patients after Yijinjing exercise is long. Researches have shown that a 48 week follow-up period will be sufficient to investigate the persistence of intervention effects on KOA.24 52 96
However, the study also has some limitations. First, the patients and therapist will not be blinded to the treatment. Second, the participants will come from the same geographic area, which limits the generalisability of the results. In addition, multi-centre efforts are needed in the future.
In summary, given the notable impact and implications of pain and dysfunction among patients with early-stage KOA, we hope this trial will provide more options for medical practitioners to control the course of KOA, and to address symptoms with as little burden as possible. Yijinjing exercise has showed potential clinical effect on the various dimensions of KOA which may improve patients’ quality of life, help them get back to normal life, and thus reduce the healthcare and economic burden on the society. This study can also provide evidence-based medicine evidence on the Yijinjing exercise treatment of KOA, which will contribute to the development of international expert consensus and play an important role in the treatment of the early-stage KOA through traditional Chinese physiotherapy.
Patient and public involvement
Before the recruitment phase, a subset of eligible KOA patients will be invited to investigate the feasibility of the study design and intervention. Their comments will then be used to make appropriate adjustments and to add health education components of interest to them. No patients or members of the public will be involved in the study design or any other parts of this protocol (including the recruitment as well as the statistical phase of the results).
Ethics statements
Patient consent for publication
Acknowledgments
Thanks to all the doctors of Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine for their help in the trial design. Thanks to Rongqian Cao and Yuanhao Shen from School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine for the demonstration of Yijinjing exercise movements and picture making. Thanks to Natchapol Opatprapai, William Lau, QUEK SUE PHIE, Adele Lim En Thong, Lye Heng Ze, Teh Yong Jia, Sebastian Chrisandy Anggaswara from Shanghai University of Traditional Chinese Medicine for the help in language simplification and grammar correction.
References
Footnotes
GG, YW and XX are joint first authors.
Contributors GG planned the study protocol and drafted the manuscript. GG, YHW, XX, KL, XZ, YG, GY, FY, and MF planned the study protocol and revised the manuscript. GG will carry out the Yijinjing exercise intervention of patients. YHW will be responsible for generating and distributing the random numbers. FY will carry out the health education of patients. XX will recruit and screen eligible participants in the outpatient department and the inpatient department. KL, XZ, YG, and GY will participate in designing the outcome measurements and assessing the outcomes. MF was the study coordinator and managed the study. All authors read and approved the final manuscript.
Funding This study is supported by Future Plan for Traditional Chinese Medicine development of Science and Technology of Shanghai Municipal Hospital of Traditional Chinese Medicine (WL-JXXK-2021001K); Future Plan for Traditional Chinese Medicine Inheritance and Development of Shanghai Municipal Hospital of Traditional Chinese Medicine (WLJH2021ZY-GZS007; WLJH2021ZY-ZYY011); National Natural Science Foundation of China (no. 82105042); Postdoctoral Science Foundation of China (no. 2021M692156); Shanghai Postdoctoral Excellence Programme (no. 2020371); 'Three Year Action Plan for Promoting Clinical Skills and Clinical Innovation in Municipal Hospitals' Training Programme for Innovative Translational Skills of Research Physicians of Shanghai Development Centre (SHDC2022CRT018). The funding sponsors had no role in the study design, analysis, collection, and interpretation of the data, or the writing and decision for publication.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.