An interventional study of 12-week intervention and 12-week attention control in Knee Discomfort and Knee Pain Chronic, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention
Objectives:
This study aims to evaluate the effectiveness of the "Jockey Club E-Generation: Impact Extension Project for Chronic Knee Pain Management", with a view to developing sustainable strategies of self-management on chronic conditions integrating with tele-rehabilitation technology.
Study design and participants:
An evaluation study adopting a randomized controlled trial design, with waitlist attention control will be conducted in Elderly community centres of Hong Kong Sheng Kung Hui Welfare Council and Christian Family Service Centre (CFSC) in Hong Kong. The proposed sample size is 858 participants, which is a convenience sample from the service user of the "Jockey Club E-Generation: Impact Extension Project for Chronic Knee Pain Management". At least 15 participants will be invited for qualitative interview.
Participants will be randomized to the intervention group or the waitlist attention control group in 1:1 ratio using block randomization with random block size of 4, 6 and 8, stratified by each centre and severity of condition. A researcher independent to the project will generate the randomization sequence by computer and keep the list. Participants in the intervention group (known as Group A to the participants) will start the 12-week intervention immediately, whereas the waitlist attention control (know as Group B to the participants) will start the intervention after 12 weeks. During the waiting period, waitlist control receives attention control.
Measurements:
The primary outcome of this study is quality of life. It will be measured by the Hong Kong Chinese version of World Health Organization Quality-of-Life Scale (WHOQOL-BREF).
The secondary outcomes are pain, physical functioning, emotional functioning, adherence rate, satisfaction score, rate of adverse events in relation to the intervention, and cost-effectiveness of the intervention.
Expected results:
The improvement in health-related quality of life of older adults is larger in the intervention group as compared to the control group; The relief in knee pain of older adults is larger in the intervention group as compared to the control group; The improvement in physical functioning of older adults is larger in the intervention group as compared to the control group; The improvement in emotional functioning of older adults is larger in the intervention group as compared to the control group.
The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
i. Aged ≥55 years;
ii. Community-dwelling;
iii. With self-reported knee pain problem currently or in the past 12 months;
iv. Cognitively sound (screened by the Clock Drawing Test (CDT) ≤ 4 (Agrell \& Dehlin, 1998));
v. Able to understand and communicate in Cantonese or Mandarin.
Exclusion Criteria:
i. Diagnosed with stroke, myocardial infarction, injury or inflammation of the knee, autoimmune disease, unable to walk in the past three months;
ii. Users/ of Hospital Authority medical consultation or physiotherapy or occupational therapy services related to osteoarthritis knee;
iii. Screened to have three or above conditions including significant knee symptom score 5 or above, WOMAC Score ≥48, 5 times Sit to Stand test >16.7 seconds, Time Up and Go Test >14 seconds, Age >80 and BMI >25.
The intervention group will start the 12-week intervention immediately
Other: 12-week intervention
The waitlist control group will have weekly educational and virtual workshops for 12 weeks. After 12 weeks assessment, the control group will receive the same intervention as the intervention group for 12 weeks.
Other: 12-week intervention · Other: 12-week attention control
Rehabilitation Exercise Plan Week 1-4 For No Symptom Group: Therapeutic home exercise prescription(2 sessions, 60 minutes per session) For Mild \& Moderate Group: Rehabilitation Plan provided by Physiotherapist (4 sessions, 60 minutes per session) Enhancement of Self-Management Capacity Week 5-8 For No Symptom Group: Educational Workshops provided by Physiotherapist (2 sessions, 60 minutes per session) For Mild \& Moderate Group: Self-management group provided by Social Worker (4 sessions, 60 minutes per session) Exercise Maintenance Week 9-12 For No Symptom Group: Mobilized Intervention (2 sessions, 60 minutes per session) For Mild \& Moderate Group: Exercise Maintenance provided by Exercise Mentor (4 sessions, 60 minutes per session)
The attention and waitlist control group will have weekly educational and virtual workshops for 12 weeks. Three topics will be covered, including online exercise class, cognitive training, leisure and recreational activities. Each session will be 30-45 minutes and each topic last for four weeks. Participants could access the virtual sessions by their electronic devices.
Change from baseline quality of life at 12 weeks.
Measured by the Hong Kong Chinese version of World Health Organization Quality-of-Life Scale (WHOQOL-BREF). Scoring based on a rule set by the World Health Organization and converted to a score between 4 and 20 for all domains, with the higher the score, the better the quality of life.
Time frame: 12 weeks after baseline.
Change from baseline quality of life at 24 weeks.
Measured by the Hong Kong Chinese version of World Health Organization Quality-of-Life Scale (WHOQOL-BREF). Scoring based on a rule set by the World Health Organization and converted to a score between 4 and 20 for all domains, with the higher the score, the better the quality of life.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline pain at 12 weeks.
Measured by the pain subscale of Chinese version of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Total score ranges from 0 to 96. Higher scores indicate worse pain, stiffness, and functional limitations.
Time frame: 12 weeks after baseline.
Change from baseline pain at 24 weeks.
Measured by the pain subscale of Chinese version of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Total score ranges from 0 to 96. Higher scores indicate worse pain, stiffness, and functional limitations.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline physical functioning, Five Times Sit-to-Stand Test at 12 weeks.
Measured by the Five Times Sit-to-Stand Test, scoring the amount of time a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test.
Time frame: 12 weeks after baseline.
Change from baseline physical functioning, Five Times Sit-to-Stand Test at 24 weeks.
Measured by the Five Times Sit-to-Stand Test, scoring the amount of time a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline physical functioning, 2-minute Step Test at 12 weeks.
Measured by the 2-minute Step Test, scoring how many times the patient's right knee reaches the point that is halfway between the midpoint of the patient's patella and the top of their iliac crest while marching in place for 2 minutes. Higher scores indicate greater levels of aerobic capacity.
Time frame: 12 weeks after baseline.
Change from baseline physical functioning, 2-minute Step Test at 24 weeks.
Measured by the 2-minute Step Test, scoring how many times the patient's right knee reaches the point that is halfway between the midpoint of the patient's patella and the top of their iliac crest while marching in place for 2 minutes. Higher scores indicate greater levels of aerobic capacity.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 12 weeks.
Measured by the Self-Efficacy to Manage Chronic Disease Scale, scoring range from 1 to 10, the higher the score, the greater the self-efficacy.
Time frame: 12 weeks after baseline.
Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 24 weeks.
Measured by the Self-Efficacy to Manage Chronic Disease Scale, scoring range from 1 to 10, the higher the score, the greater the self-efficacy.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, Cognitive Symptom Management at 12 weeks.
Measured by the Cognitive Symptom Management (CSM) Scale, scoring range from 0 to 5, with a higher score indicating more practice of these techniques.
Time frame: 12 weeks after baseline.
Change from baseline emotional functioning, Cognitive Symptom Management at 24 weeks.
Measured by the Cognitive Symptom Management (CSM) Scale, scoring range from 0 to 5, with a higher score indicating more practice of these techniques.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, Sleep Quality at 12 weeks.
Measured by the Pittsburgh Sleep Quality Index (PSQI), scoring range from 0 to 21 with higher score indicating poorer quality.
Time frame: 12 weeks after baseline.
Change from baseline emotional functioning, Sleep Quality at 24 weeks.
Measured by the Pittsburgh Sleep Quality Index (PSQI), scoring range from 0 to 21 with higher score indicating poorer quality.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, depression at 12 weeks.
Measured by the Patient Health Questionnaire-9 (PHQ-9), scoring range from 0 to 27, the higher the score, the more severe the depression.
Time frame: 12 weeks after baseline.
Change from baseline emotional functioning, depression at 24 weeks.
Measured by the Patient Health Questionnaire-9 (PHQ-9), scoring range from 0 to 27, the higher the score, the more severe the depression.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, quality of life at 12 weeks.
Measured by the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), scoring based on a rule set by the World Health Organization and converted to a score between 4 and 20 for all domains, with the higher the score, the better the quality of life.
Time frame: 12 weeks after baseline.
Change from baseline emotional functioning, quality of life at 24 weeks.
Measured by the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), scoring based on a rule set by the World Health Organization and converted to a score between 4 and 20 for all domains, with the higher the score, the better the quality of life.
Time frame: 24 weeks after baseline, only for waitlist control group.
Adherence rate
Collected by a practice record in the App, as well as class attendance record for face-to-face classes
Time frame: During 12 weeks intervention
Satisfaction score
Assessed by a five-point Likert scale, 0 indicates not satisfied at all, 4 indicates very satisfied. The higher the score, the higher the satisfaction level.
Time frame: 12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
Rate of adverse events in relation to the intervention
Symptoms and adverse events will be recorded by a single question.
Time frame: 12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
Cost-effectiveness of the intervention
Expenses related to (emergency department visits, outpatient, inpatient, rehabilitation, over-the-counter medication and supplement) related to knee pain or falls will be collected. Costing of the intervention from the service provider will be obtained from the service provider directly.
Time frame: 12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
Plan to share: No
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