Knee DiscomfortNCT06569836
Evaluation Study for the "Jockey Club E-Generation: Impact Extension Project for Chronic Knee Pain Management"
A study testing 12-week intervention in people with Knee Discomfort and Knee Pain Chronic, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Discomfort, Knee Pain Chronic
- What is being tested?
- 12-week intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 858 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Aug 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥55 years;
- Community-dwelling;
- With self-reported knee pain problem currently or in the past 12 months;
- Cognitively sound (screened by the Clock Drawing Test (CDT) ≤ 4 (Agrell \& Dehlin, 1998));
- Able to understand and communicate in Cantonese or Mandarin.
Who cannot join
- Diagnosed with stroke, myocardial infarction, injury or inflammation of the knee, autoimmune disease, unable to walk in the past three months;
- Users/ of Hospital Authority medical consultation or physiotherapy or occupational therapy services related to osteoarthritis knee;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Elderly community centre
Hong Kong
Pui Hing Chau, 3917 6626, phpchau@hku.hk
About this study
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.
Read more
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.
- Conditions
- Knee Discomfort, Knee Pain Chronic
- Being tested
- 12-week intervention, 12-week attention control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week interventionOther
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)
12-week attention controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Assigned intervention | Other | The intervention group will start the 12-week intervention immediately Receives: Other: 12-week intervention |
| Assigned waitlist control | Other | 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. Receives: Other: 12-week intervention; Other: 12-week attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after baseline.
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start19 Aug 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiscomfortStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 858 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Sheng Kung Hui Welfare Council Limited
- Responsible party
- Principal investigator, Dr. Pui-Hing Chau, The University of Hong Kong
- Investigators
- Pui Hing Chau, PhD, Principal investigator, School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569836
- Sponsor's protocol ID
- AR230018
- Status last verified
- Dec 2024
- First submitted
- 20 Aug 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study for the "Jockey Club E-Generation: Impact Extension Project for Chronic Knee Pain Management"
- ClinicalTrials.gov ID
- NCT06569836
- Acronym / sponsor ID
- AR230018
- Conditions
- Knee Discomfort, Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 858 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Sheng Kung Hui Welfare Council Limited
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Aug 2024 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assigned intervention | Other | Other: 12-week interventionThe intervention group will start the 12-week intervention immediately |
| Assigned waitlist control | Other | Other: 12-week intervention, Other: 12-week attention controlThe 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥55 years;
- Community-dwelling;
- With self-reported knee pain problem currently or in the past 12 months;
- Cognitively sound (screened by the Clock Drawing Test (CDT) ≤ 4 (Agrell \& Dehlin, 1998));
- Able to understand and communicate in Cantonese or Mandarin.
Key exclusion criteria (3 listed)
- Diagnosed with stroke, myocardial infarction, injury or inflammation of the knee, autoimmune disease, unable to walk in the past three months;
- Users/ of Hospital Authority medical consultation or physiotherapy or occupational therapy services related to osteoarthritis knee;
- 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.
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 |
|---|---|---|
| 12-week interventionRehabilitation 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) | Other | Assigned intervention, Assigned waitlist control |
| 12-week attention controlThe 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. | Other | Assigned waitlist control |
Primary outcome
Change from baseline quality of life at 12 weeks.
Time frame: 12 weeks after baseline.
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.
21 secondary outcomes
Change from baseline quality of life at 24 weeks.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline pain at 12 weeks.
Time frame: 12 weeks after baseline.
Change from baseline pain at 24 weeks.
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.
Time frame: 12 weeks after baseline.
Change from baseline physical functioning, Five Times Sit-to-Stand Test at 24 weeks.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline physical functioning, 2-minute Step Test at 12 weeks.
Time frame: 12 weeks after baseline.
Change from baseline physical functioning, 2-minute Step Test at 24 weeks.
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.
Time frame: 12 weeks after baseline.
Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 24 weeks.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, Cognitive Symptom Management at 12 weeks.
Time frame: 12 weeks after baseline.
Change from baseline emotional functioning, Cognitive Symptom Management at 24 weeks.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, Sleep Quality at 12 weeks.
Time frame: 12 weeks after baseline.
Change from baseline emotional functioning, Sleep Quality at 24 weeks.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, depression at 12 weeks.
Time frame: 12 weeks after baseline.
Change from baseline emotional functioning, depression at 24 weeks.
Time frame: 24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, quality of life at 12 weeks.
Time frame: 12 weeks after baseline.
Change from baseline emotional functioning, quality of life at 24 weeks.
Time frame: 24 weeks after baseline, only for waitlist control group.
Adherence rate
Time frame: During 12 weeks intervention
Satisfaction score
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
Time frame: 12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
Cost-effectiveness of the intervention
Time frame: 12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Pui Hing Chau, PhD principal investigator
School of Nursing, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week intervention in people with Knee Discomfort and Knee Pain Chronic, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Dec 2024. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pui Hing Chau, PhD (3917 6626, phpchau@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline quality of life at 12 weeks. (time frame: 12 weeks after baseline.). 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 5 Dec 2024.