Osteoarthritis of KneePRTKAONCT06983912
Preoperative Rehabilitation Training and Total Knee Arthroplasty Outcomes
A study testing Preoperative Rehabilitation Training in people with Osteoarthritis of Knee, run by Fuzhou University Affiliated Provincial Hospital.
Trial summary
Joint replacement surgery is an effective treatment for severe joint diseases, but the postoperative recovery process is complex and lengthy. Preoperative rehabilitation training, as an important part of preoperative preparation, has been proven to significantly improve postoperative recovery outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Preoperative Rehabilitation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Aug 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis is osteoarthritis and Scheduled for joint replacement surgery.
- Age ≥18 years old and ≤90 years old, with no gender restrictions.
- Patients voluntarily participate in the study and sign the informed consent form.
Who cannot join
- Severe cardiopulmonary insufficiency, unable to tolerate rehabilitation training.
- Neurological disorders leading to motor dysfunction.
- Mental illnesses that prevent cooperation with rehabilitation training.
- Severe joint deformities or muscle atrophy present before surgery, affecting the implementation of rehabilitation training.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Preoperative Rehabilitation on Functional Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial
Joint replacement surgery is an effective treatment for severe joint diseases, but the postoperative recovery process is complex and lengthy. Preoperative rehabilitation training, as an important part of preoperative preparation, has been proven to significantly improve postoperative recovery outcomes. However, there is currently a lack of systematic research on the optimal protocols and duration of preoperative rehabilitation training and their specific impacts on postoperative recovery. This study aims to evaluate the effects of preoperative rehabilitation training on postoperative recovery after joint replacement through a randomized controlled trial, providing scientific evidence for clinical practice.
- Conditions
- Osteoarthritis of Knee
- Being tested
- Preoperative Rehabilitation Training
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Rehabilitation TrainingBehavioural
Initiate preoperative Physical Rehabilitation Training (PRT) starting from the preoperative period, with training five days a week up until the day before surgery. This includes:
Muscle Strength Training: Isometric contractions of the quadriceps, straight leg raises, etc., for 15-20 minutes per session, twice daily.
Joint Mobility Training: Flexion and extension exercises of the knee joint, ankle pump exercises, etc., for 10-15 minutes per session, twice daily.
Balance Training: One-legged standing, center of gravity shifting exercises, etc., for 10-15 minutes per session, twice daily.
Activities of Daily Living Training: Transfer training from sitting to standing, walking exercises, etc., for 10-15 minutes per session, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Not described |
| Preoperative Rehabilitation Training | Experimental | Not described Receives: Behavioral: Preoperative Rehabilitation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Joint Function Assessment
Knee injury and Osteoarthritis Outcome Score (KOSS): KOOS is a scale used to assess symptoms and function in patients with knee injury and osteoarthritis, widely applied in clinical practice and research. It includes five dimensions (pain, other symptoms, function in daily living, function in sport and recreation, quality of life), with each dimension comprising several questions that patients rate based on their personal conditions. The scoring range for each question is 0-10 points, where 0 indicates no symptoms or difficulty, and 10 indicates the most severe symptoms or difficulties. The total score for each dimension is the average of all the questions within that dimension, ranging from 0 to 100 points. The higher the score, the milder the symptoms and the better the function.
Measured: Following total knee arthroplasty, assessments are typically conducted at the 1st, 3rd, 6th, and 12th month post-surgery
Secondary outcomes (1)
Postoperative Assessment
Aggregated Locomotor Function: ALF score is a scale designed to assess knee joint function, primarily by measuring the time it takes for patients to complete specific physical tasks to evaluate their motor function. This scale includes the following three parts: 8-meter walking time, time to climb up and down stairs, and chair transfer time. The total ALF score is obtained by adding the average time of the above three tasks. The shorter the time, the lower the score, indicating better motor function.
Measured: Following total knee arthroplasty, assessments are typically conducted at the 1st, 3rd, 6th, and 12th month post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou University Affiliated Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiqi Ding, Fuzhou University Affiliated Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983912
- Sponsor's protocol ID
- FuzhouAffiliated
- Acronym
- PRTKAO
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Rehabilitation on Functional Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06983912
- Acronym / sponsor ID
- PRTKAO / FuzhouAffiliated
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fuzhou University Affiliated Provincial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 21 May 2025 (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.
Joint replacement surgery is an effective treatment for severe joint diseases, but the postoperative recovery process is complex and lengthy. Preoperative rehabilitation training, as an important part of preoperative preparation, has been proven to significantly improve postoperative recovery outcomes. However, there is currently a lack of systematic research on the optimal protocols and duration of preoperative rehabilitation training and their specific impacts on postoperative recovery. This study aims to evaluate the effects of preoperative rehabilitation training on postoperative recovery after joint replacement through a randomized controlled trial, providing scientific evidence for clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | – |
| Preoperative Rehabilitation Training | Experimental | Behavioral: Preoperative Rehabilitation Training |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis is osteoarthritis and Scheduled for joint replacement surgery.
- Age ≥18 years old and ≤90 years old, with no gender restrictions.
- Patients voluntarily participate in the study and sign the informed consent form.
Key exclusion criteria (4 listed)
- Severe cardiopulmonary insufficiency, unable to tolerate rehabilitation training.
- Neurological disorders leading to motor dysfunction.
- Mental illnesses that prevent cooperation with rehabilitation training.
- Severe joint deformities or muscle atrophy present before surgery, affecting the implementation of rehabilitation training.
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 |
|---|---|---|
| Preoperative Rehabilitation TrainingInitiate preoperative Physical Rehabilitation Training (PRT) starting from the preoperative period, with training five days a week up until the day before surgery. This includes: Muscle Strength Training: Isometric contractions of the quadriceps, straight leg raises, etc., for 15-20 minutes per session, twice daily. Joint Mobility Training: Flexion and extension exercises of the knee joint, ankle pump exercises, etc., for 10-15 minutes per session, twice daily. Balance Training: One-legged standing, center of gravity shifting exercises, etc., for 10-15 minutes per session, twice daily. Activities of Daily Living Training: Transfer training from sitting to standing, walking exercises, etc., for 10-15 minutes per session, twice daily. | Behavioural | Preoperative Rehabilitation Training |
Primary outcome
Knee Joint Function Assessment
Time frame: Following total knee arthroplasty, assessments are typically conducted at the 1st, 3rd, 6th, and 12th month post-surgery
Knee injury and Osteoarthritis Outcome Score (KOSS): KOOS is a scale used to assess symptoms and function in patients with knee injury and osteoarthritis, widely applied in clinical practice and research. It includes five dimensions (pain, other symptoms, function in daily living, function in sport and recreation, quality of life), with each dimension comprising several questions that patients rate based on their personal conditions. The scoring range for each question is 0-10 points, where 0 indicates no symptoms or difficulty, and 10 indicates the most severe symptoms or difficulties. The total score for each dimension is the average of all the questions within that dimension, ranging from 0 to 100 points. The higher the score, the milder the symptoms and the better the function.
1 secondary outcome
Postoperative Assessment
Time frame: Following total knee arthroplasty, assessments are typically conducted at the 1st, 3rd, 6th, and 12th month post-surgery.
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 21 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis of Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Rehabilitation Training in people with Osteoarthritis of Knee, run by Fuzhou University Affiliated Provincial Hospital.
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 3 inclusion and 4 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 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Haiqi Ding (0591-88217200, dhq9119@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Joint Function Assessment (time frame: Following total knee arthroplasty, assessments are typically conducted at the 1st, 3rd, 6th, and 12th month post-surgery). 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 21 May 2025.