Knee OsteoarthristisNCT07319546
Accelerated Rehabilitation in Individuals After Total Knee Arthroplasty
A study testing Accelerated exercise and Routine exercise in people with Knee Osteoarthristis and Arthroplasties, Knee Replacement, run by Mahidol University at 1 site in China.
Trial summary
The primary aim of this double-blind randomized controlled trial is to evaluate the effectiveness of an accelerated rehabilitation protocol on knee joint function and quality of life in individuals undergoing TKA compared to conventional rehabilitation in Dali, Yunan, China. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthristis, Arthroplasties, Knee Replacement
- What is being tested?
- Accelerated exercise and Routine exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Jun 2027
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with end-stage knee OA necessitating primary unilateral TKA.
Who cannot join
- History of joint infections, cancer, or inflammatory arthritis.
- End-stage OA from rheumatoid or septic arthritis.
- Individuals with neurological disorders such as Alzheimer's disease, - Parkinson's disease, stroke.
- Individuals who are unable to follow a structured rehabilitation protocol.
- Previous history of knee surgeries (other than arthroscopy).
- Severe comorbidities that would hinder participation (e.g., advanced cardiovascular diseases).
- Individuals who have severe osteoporosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hospital
Dali, Yunnan
Liying Yang, PT, M.Sc., +86 18787638700, liying.yan@student.mahidol.ac.th
About this study
Official title: Effectiveness of Accelerated Rehabilitation on Knee Joint Function and Quality of Life in Individuals With Total Knee Arthroplasty: A Double Blind Randomized Controlled Trial
The primary aim of this double-blind randomized controlled trial is to evaluate the effectiveness of an accelerated rehabilitation protocol on knee joint function and quality of life in individuals undergoing TKA compared to conventional rehabilitation in Dali, Yunan, China. The study will include patients aged 50-80 years who are scheduled for primary unilateral TKA. Participants will be randomly assigned to either an accelerated rehabilitation group or conventional rehabilitation group. The primary outcomes will include knee joint function, assessed using the KOOS and quality of life measures using the SF-36 surveys. The study will follow participants for 6 months post-surgery to assess longer-term outcomes. This study will not include individuals undergoing revision TKA or those with severe comorbid conditions. The results will provide critical insights into the role of accelerated rehabilitation in improving post-operative recovery, functional outcomes, and overall quality of life for TKA patients.
- Being tested
- Accelerated exercise, Routine exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated exerciseBehavioural
Based on optimal and accelerated concepts
Routine exerciseBehavioural
Conventional program
| Study group | Role | What they receive |
|---|---|---|
| Accelerated rehabilitation | Experimental | Rehabilitaion after TKR with the accelerated and optimal loading concepts Receives: Behavioral: Accelerated exercise |
| Conventional rehabilitation | Active comparator | Not described Receives: Behavioral: Routine exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: From enrollment to the end of 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (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 Mahidol UniversityThe 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Komsak Sinsurin, Ph.D., DPT, Study chair, Mahidol UniversityLiying Yang, Principal investigator, West Yunnan University of Applied Sciences, Yunnan province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319546
- Sponsor's protocol ID
- MU-CIRB 2025/443.2908
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Accelerated Rehabilitation on Knee Joint Function and Quality of Life in Individuals With Total Knee Arthroplasty: A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07319546
- Acronym / sponsor ID
- MU-CIRB 2025/443.2908
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jan 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.
The primary aim of this double-blind randomized controlled trial is to evaluate the effectiveness of an accelerated rehabilitation protocol on knee joint function and quality of life in individuals undergoing TKA compared to conventional rehabilitation in Dali, Yunan, China. The study will include patients aged 50-80 years who are scheduled for primary unilateral TKA. Participants will be randomly assigned to either an accelerated rehabilitation group or conventional rehabilitation group. The primary outcomes will include knee joint function, assessed using the KOOS and quality of life measures using the SF-36 surveys. The study will follow participants for 6 months post-surgery to assess longer-term outcomes. This study will not include individuals undergoing revision TKA or those with severe comorbid conditions. The results will provide critical insights into the role of accelerated rehabilitation in improving post-operative recovery, functional outcomes, and overall quality of life for TKA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated rehabilitation | Experimental | Behavioral: Accelerated exerciseRehabilitaion after TKR with the accelerated and optimal loading concepts |
| Conventional rehabilitation | Active comparator | Behavioral: Routine exercise |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with end-stage knee OA necessitating primary unilateral TKA.
Key exclusion criteria (7 listed)
- History of joint infections, cancer, or inflammatory arthritis.
- End-stage OA from rheumatoid or septic arthritis.
- Individuals with neurological disorders such as Alzheimer's disease, - Parkinson's disease, stroke.
- Individuals who are unable to follow a structured rehabilitation protocol.
- Previous history of knee surgeries (other than arthroscopy).
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 |
|---|---|---|
| Accelerated exerciseBased on optimal and accelerated concepts | Behavioural | Accelerated rehabilitation |
| Routine exerciseConventional program | Behavioural | Conventional rehabilitation |
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: From enrollment to the end of 6-month follow-up
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 6 Jan 2026.
- 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.
Komsak Sinsurin, Ph.D., DPT study chair
Mahidol University
Liying Yang principal investigator
West Yunnan University of Applied Sciences, Yunnan province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated exercise and Routine exercise in people with Knee Osteoarthristis and Arthroplasties, Knee Replacement, run by Mahidol University at 1 site in China.
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 1 inclusion and 7 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 6 Jan 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 China. 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 Liying Yang, PT, M.Sc. (+86 18787638700, liying.yan@student.mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: From enrollment to the end of 6-month follow-up). 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 6 Jan 2026.