Knee OsteoarthristisNCT07912333
Wearable Device Guided Exercise for Patients on Total Knee Arthroplasty Wait-list
A study testing Wearable Device in people with Knee Osteoarthristis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Total knee arthroplasty (TKA) is a cost effective solution for people with end-stage knee osteoarthritis. Given Hong Kong's large senior population and age as the primary risk factor for osteoarthritis, waiting times for total knee arthroplasty can reach 30 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Wearable Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Nov 2026to 30 Jun 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- end-stage knee osteoarthritis according to European Alliance of Associations for Rheumatology
- Radiographic evidence of joint damage
- Significant functional limitations
- Severe knee pain
Who cannot join
- Had undergone bilateral TKA,
- exercise contraindication
- terminal illness
- chronic immobility
- acute myocardial infraction within previous six weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tianzhi Jiang, M.Sc contact
Hong Kong1 site
Prince of Wales Hospital
Shatin, New Territories
Tianzhi Jiang, M.Sc, TJjiang@cuhk.edu.hk
Dhananjaya Sutanto, Ph.D., dhananjayasutanto@cuhk.edu.hk
About this study
Official title: The Application of Wearable Device Guided Pre-operative Exercise Programme for Patients Awaiting Total Knee Arthroplasty: A Randomized Controlled Trial
Total knee arthroplasty (TKA) is a cost effective solution for people with end-stage knee osteoarthritis. Given Hong Kong's large senior population and age as the primary risk factor for osteoarthritis, waiting times for total knee arthroplasty can reach 30 months. To manage this long wait list, patients would be enrolled to a structured exercise program with group and home based exercise. Currently limited options are available for home based exercise adherence monitoring for TKA patients on the wait-list. This study will assess the effect of wearable device with smartphone application to guide home based exercise among these wait-list patients. The main hypothesis is that the use of wearable device will decrease patient's pain level and improve their physical activity level.
Read the detailed description
All participants will consent that their anonymized data will be collected and used for scientific publications in accordance to the declaration of Helsinki. Patients on the wait-list for primary TKA at Prince of Wales Hospital in Hong Kong would be recruited and randomized to either wearable device or control group with measurements done at baseline, six weeks and six months post intervention. Control group received standard training intervention and follow up schedules, while the wearable device group would receive the wearable device and associated smartphone application along with familiarization training over the first six weeks of training.
- Conditions
- Knee Osteoarthristis
- Being tested
- Wearable Device, Control
- Keywords
- knee osteoarthritis, home based exercise, wearable device, training adherence, KOOS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable DeviceDevice
Participants received the same group and home based exercise prescription, with the same measurement timeline as control group. Participants received wearable device with application for smartphone for home exercise monitoring and familiarization during group training sessions
ControlDevice
Participants received home based exercise prescription only.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants received standardized group and home based intervention with similar measurement time points and exercise prescription as the intervention Receives: Device: Control |
| Wearable | Experimental | Participants received wearable device with complementary smartphone application for exercise monitoring Receives: Device: Wearable Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury Osteoarthritis Outcome Score (KOOS)
10 minute self completed questionnaire measuring five sub-scales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Each sub-scale scored from 0 to 100, with 100 being no complaints.
Measured: baseline, 6 weeks and 6 months
Secondary outcomes (9)
Knee Flexion during walking
Patients walk and have their knee flexion measured using optical motion capture, outcome in degrees.
Measured: baseline, 6 weeks and 6 months
Hip Flexion during walking
Patients walk and have their hip flexion measured using optical motion capture, outcome in degrees.
Measured: baseline, 6 weeks and 6 months
Knee Flexion during sit-to-stand
Patients does sit-to-stand and have their knee flexion measured using optical motion capture, outcome in degrees.
Measured: baseline, 6 weeks and 6 months
Hip Flexion during sit-to-stand
Patients does sit-to-stand and have their hip flexion measured using optical motion capture, outcome in degrees.
Measured: baseline, 6 weeks and 6 months
30 seconds chair to stand test
Participant sat on on a chair then execute repetitive sit-to-stand movement as much as possible within 30 seconds, outcome in number of repetitions completed.
Measured: baseline, 6 weeks and 6 months
Functional Reach Test
Participant stand with their feet together and legs straight, then try to reach forward as far as possible, outcome in reach distance (centimeter).
Measured: baseline, 6 weeks and 6 months
Timed Up and Go Test
Participant started in seated position, on instruction would stand up, walk forward for three meters, return back to the chair and sit down. Outcome in time (seconds) needed to complete.
Measured: baseline, 6 weeks and 6 months
Knee Society Score (KSS)
Physician assessed questionnaire measuring patient pain, range of motion, stability, and joint alignment, scoring between 0 to 100, with 100 being perfect score.
Measured: baseline, 6 weeks and 6 months
Knee Society Functional Score
Patient self-assessment questionnaire measuring their ability to execute physical activities, scoring between 0 to 100, with 100 being perfect score.
Measured: baseline, 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start10 Nov 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by Chinese 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912333
- Sponsor's protocol ID
- 2026.428
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only anonymized data can be shared with interested parties as this is clinically sensitive data
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Wearable Device Guided Pre-operative Exercise Programme for Patients Awaiting Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07912333
- Acronym / sponsor ID
- 2026.428
- Conditions
- Knee Osteoarthristis
- Keywords
- knee osteoarthritis, home based exercise, wearable device, training adherence, KOOS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Nov 2026 (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.
Total knee arthroplasty (TKA) is a cost effective solution for people with end-stage knee osteoarthritis. Given Hong Kong's large senior population and age as the primary risk factor for osteoarthritis, waiting times for total knee arthroplasty can reach 30 months. To manage this long wait list, patients would be enrolled to a structured exercise program with group and home based exercise. Currently limited options are available for home based exercise adherence monitoring for TKA patients on the wait-list. This study will assess the effect of wearable device with smartphone application to guide home based exercise among these wait-list patients. The main hypothesis is that the use of wearable device will decrease patient's pain level and improve their physical activity level.
Detailed description
All participants will consent that their anonymized data will be collected and used for scientific publications in accordance to the declaration of Helsinki. Patients on the wait-list for primary TKA at Prince of Wales Hospital in Hong Kong would be recruited and randomized to either wearable device or control group with measurements done at baseline, six weeks and six months post intervention. Control group received standard training intervention and follow up schedules, while the wearable device group would receive the wearable device and associated smartphone application along with familiarization training over the first six weeks of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: ControlParticipants received standardized group and home based intervention with similar measurement time points and exercise prescription as the intervention |
| Wearable | Experimental | Device: Wearable DeviceParticipants received wearable device with complementary smartphone application for exercise monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- end-stage knee osteoarthritis according to European Alliance of Associations for Rheumatology
- Radiographic evidence of joint damage
- Significant functional limitations
- Severe knee pain
Key exclusion criteria (5 listed)
- Had undergone bilateral TKA,
- exercise contraindication
- terminal illness
- chronic immobility
- acute myocardial infraction within previous six weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable DeviceParticipants received the same group and home based exercise prescription, with the same measurement timeline as control group. Participants received wearable device with application for smartphone for home exercise monitoring and familiarization during group training sessions | Device | Wearable |
| ControlParticipants received home based exercise prescription only. | Device | Control |
Primary outcome
Knee Injury Osteoarthritis Outcome Score (KOOS)
Time frame: baseline, 6 weeks and 6 months
10 minute self completed questionnaire measuring five sub-scales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Each sub-scale scored from 0 to 100, with 100 being no complaints.
9 secondary outcomes
Knee Flexion during walking
Time frame: baseline, 6 weeks and 6 months
Hip Flexion during walking
Time frame: baseline, 6 weeks and 6 months
Knee Flexion during sit-to-stand
Time frame: baseline, 6 weeks and 6 months
Hip Flexion during sit-to-stand
Time frame: baseline, 6 weeks and 6 months
30 seconds chair to stand test
Time frame: baseline, 6 weeks and 6 months
Functional Reach Test
Time frame: baseline, 6 weeks and 6 months
Timed Up and Go Test
Time frame: baseline, 6 weeks and 6 months
Knee Society Score (KSS)
Time frame: baseline, 6 weeks and 6 months
Knee Society Functional Score
Time frame: baseline, 6 weeks and 6 months
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 3 Nov 2026.
- Individual participant dataSharing planned: No. only anonymized data can be shared with interested parties as this is clinically sensitive data
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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.
Tianzhi Jiang, M.Sc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Device in people with Knee Osteoarthristis, run by Chinese 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 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 Michael TY Ong, Professor ((852) 3505-2723, michael.ong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury Osteoarthritis Outcome Score (KOOS) (time frame: baseline, 6 weeks and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.