Rheumatoid Arthritis (RA)NCT07246811
Rehabilitation Exercise Intervention for Rheumatoid Arthritis Patients Using Artificial Intelligence-Based Exercise Prescription System
A study testing AI Exercise Prescription, education and basic joint mobility exercises and paper-based exercise prescription in people with Rheumatoid Arthritis (RA), run by Peking University Third Hospital at 1 site in China.
Trial summary
This is a single-center, randomized, parallel-controlled trial evaluating the efficacy and safety of an artificial intelligence-based exercise prescription system for rehabilitation in rheumatoid arthritis (RA) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- AI Exercise Prescription, education and basic joint mobility exercises and paper-based exercise prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 15 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years Meets 2010 ACR/EULAR classification criteria for RA Low-to-moderate disease activity (assessed by rheumatologist) Knee joint involvement Willing and able to provide informed consent
Who cannot join
- Existing joint ankylosis (fibrous or bony) Acute flare or extra-articular soft tissue lesions Comorbid with other rheumatic diseases (e.g., SLE, Sjögren's syndrome) Severe hepatic or renal impairment Knee joint VAS pain score >4 (0-10 scale) Psychiatric disorders
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
Department of Rehabilitation Medicine, Peking University People's Hospital
Beijing, Beijing Municipality, 100000
yansong li, 86-010-88316683, 568475833@qq.com
About this study
This is a single-center, randomized, parallel-controlled trial evaluating the efficacy and safety of an artificial intelligence-based exercise prescription system for rehabilitation in rheumatoid arthritis (RA) patients. A total of 147 patients with low-to-moderate disease activity will be randomly assigned to three groups: AI exercise prescription group (personalized AI system guidance), paper exercise prescription group (traditional paper guidance), and routine care group. The intervention will last for 6 weeks with 6-month follow-up assessments evaluating joint function, pain, and quality of life indicators.
Read the detailed description
This three-arm randomized controlled trial (RCT) uses Redcap system for 1:1:1 randomization. The AI exercise prescription group receives intervention through the "Yidong Health AI Exercise Prescription System" delivered via WeChat mini-program; the paper exercise prescription group receives traditional paper-based guidance; and the routine care group receives standardized health education and basic exercise instructions. The primary outcome measure is knee flexion range of motion (ROM) at 6 months, with secondary outcomes including HSS score, WOMAC index, TUG test, BBS balance scale, and other functional assessment measures.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- AI Exercise Prescription, education and basic joint mobility exercises, paper-based exercise prescription
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Exercise PrescriptionOther
Uses "Yidong Health AI Exercise Prescription System" delivered via WeChat mini-program, providing personalized exercise prescriptions (three sets: A/B/C) with AI Q\&A module. Physicians adjust prescriptions weekly based on patient feedback.
education and basic joint mobility exercisesOther
Receives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses.
paper-based exercise prescriptionOther
Receives paper-based exercise prescription developed by rehabilitation therapists, including warm-up, formal training (bridging, modified bird-dog exercise, etc.) and cool-down stretching.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care Group | Active comparator | Receives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses. Receives: Other: education and basic joint mobility exercises |
| Paper Exercise Prescription Group | Active comparator | Receives paper-based exercise prescription developed by rehabilitation therapists, including warm-up, formal training (bridging, modified bird-dog exercise, etc.) and cool-down stretching. Receives: Other: paper-based exercise prescription |
| AI Exercise Prescription Group | Experimental | Uses "Yidong Health AI Exercise Prescription System" delivered via WeChat mini-program, providing personalized exercise prescriptions (three sets: A/B/C) with AI Q\&A module. Physicians adjust prescriptions weekly based on patient feedback. Receives: Other: AI Exercise Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee flexion range of motion
Knee Flexion Range of Motion Unit of Measure: Degrees (°) Knee flexion range of motion refers to the maximum angle through which the knee joint can bend, measured from the straight (extended) position to the farthest point the lower leg can move toward the thigh. This assessment evaluates the flexibility and functional mobility of the knee, which is critical for daily activities such as walking, climbing stairs, and sitting.
Relevant definitions and criteria:
A "normal" range of motion for knee flexion in adults is generally considered to be 135° to 150°, though this can vary slightly based on age, physical conditioning, and individual anatomy.
Limited knee flexion (e.g., less than 90°) may indicate joint stiffness, muscle tightness, or underlying issues such as injury, arthritis, or post-surgical scarring.
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Secondary outcomes (12)
Hospital for Special Surgery (HSS) Score
Hospital for Special Surgery (HSS) Score Unit of Measure: Points (out of 100) The Hospital for Special Surgery (HSS) Score is a comprehensive assessment tool used primarily in orthopedics, especially in evaluating the condition of the knee joint. It helps medical professionals determine the overall function and well - being of the knee, which is crucial for guiding treatment decisions, such as whether conservative management or surgical intervention is more appropriate.Total Score Range: The HSS Score ranges from 0 to 100 points.
Interpretation of Scores:
> 85 points: Considered "excellent". At this level, the knee is functioning very well, with minimal pain and good functional ability. In many cases, patients with such scores may not require significant medical intervention or may only need conservative measures like rest and exercise adjustments.
70 - 85 points: Rated as "good". The knee has some minor issues, but overall function is still acceptable. Appropriate conservative
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Timed Up and Go (TUG) Test
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Berg Balance Scale (BBS)
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Isokinetic Muscle Strength Test
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Gait and Plantar Pressure Analysis
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Arthritis Self-Efficacy Scale (ASES-8)
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Patient Health Questionnaire-9 (PHQ-9)
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Generalized Anxiety Disorder-7 (GAD-7)
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Health Assessment Questionnaire (HAQ)
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Laboratory indicators (RF, CRP, complete blood count)
Measured: Baseline, post-intervention (6 weeks), 3-month follow-up, 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 posted24 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246811
- Sponsor's protocol ID
- 2025-q003
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 24 Nov 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Exercise Intervention for Rheumatoid Arthritis Patients Using Artificial Intelligence-Based Exercise Prescription System
- ClinicalTrials.gov ID
- NCT07246811
- Acronym / sponsor ID
- 2025-q003
- Conditions
- Rheumatoid Arthritis (RA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 24 Nov 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.
This is a single-center, randomized, parallel-controlled trial evaluating the efficacy and safety of an artificial intelligence-based exercise prescription system for rehabilitation in rheumatoid arthritis (RA) patients. A total of 147 patients with low-to-moderate disease activity will be randomly assigned to three groups: AI exercise prescription group (personalized AI system guidance), paper exercise prescription group (traditional paper guidance), and routine care group. The intervention will last for 6 weeks with 6-month follow-up assessments evaluating joint function, pain, and quality of life indicators.
Detailed description
This three-arm randomized controlled trial (RCT) uses Redcap system for 1:1:1 randomization. The AI exercise prescription group receives intervention through the "Yidong Health AI Exercise Prescription System" delivered via WeChat mini-program; the paper exercise prescription group receives traditional paper-based guidance; and the routine care group receives standardized health education and basic exercise instructions. The primary outcome measure is knee flexion range of motion (ROM) at 6 months, with secondary outcomes including HSS score, WOMAC index, TUG test, BBS balance scale, and other functional assessment measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine Care Group | Active comparator | Other: education and basic joint mobility exercisesReceives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses. |
| Paper Exercise Prescription Group | Active comparator | Other: paper-based exercise prescriptionReceives paper-based exercise prescription developed by rehabilitation therapists, including warm-up, formal training (bridging, modified bird-dog exercise, etc.) and cool-down stretching. |
| AI Exercise Prescription Group | Experimental | Other: AI Exercise PrescriptionUses "Yidong Health AI Exercise Prescription System" delivered via WeChat mini-program, providing personalized exercise prescriptions (three sets: A/B/C) with AI Q\&A module. Physicians adjust prescriptions weekly based on patient feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18 years Meets 2010 ACR/EULAR classification criteria for RA Low-to-moderate disease activity (assessed by rheumatologist) Knee joint involvement Willing and able to provide informed consent
Key exclusion criteria (1 listed)
- Existing joint ankylosis (fibrous or bony) Acute flare or extra-articular soft tissue lesions Comorbid with other rheumatic diseases (e.g., SLE, Sjögren's syndrome) Severe hepatic or renal impairment Knee joint VAS pain score >4 (0-10 scale) Psychiatric disorders
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 |
|---|---|---|
| AI Exercise PrescriptionUses "Yidong Health AI Exercise Prescription System" delivered via WeChat mini-program, providing personalized exercise prescriptions (three sets: A/B/C) with AI Q\&A module. Physicians adjust prescriptions weekly based on patient feedback. | Other | AI Exercise Prescription Group |
| education and basic joint mobility exercisesReceives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses. | Other | Routine Care Group |
| paper-based exercise prescriptionReceives paper-based exercise prescription developed by rehabilitation therapists, including warm-up, formal training (bridging, modified bird-dog exercise, etc.) and cool-down stretching. | Other | Paper Exercise Prescription Group |
Primary outcome
Knee flexion range of motion
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Knee Flexion Range of Motion Unit of Measure: Degrees (°) Knee flexion range of motion refers to the maximum angle through which the knee joint can bend, measured from the straight (extended) position to the farthest point the lower leg can move toward the thigh. This assessment evaluates the flexibility and functional mobility of the knee, which is critical for daily activities such as walking, climbing stairs, and sitting. Relevant definitions and criteria: A "normal" range of motion for knee flexion in adults is generally considered to be 135° to 150°, though this can vary slightly based on age, physical conditioning, and individual anatomy. Limited knee flexion (e.g., less than 90°) may indicate joint stiffness, muscle tightness, or underlying issues such as injury, arthritis, or post-surgical scarring.
12 secondary outcomes
Hospital for Special Surgery (HSS) Score
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Timed Up and Go (TUG) Test
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Berg Balance Scale (BBS)
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Isokinetic Muscle Strength Test
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Gait and Plantar Pressure Analysis
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Arthritis Self-Efficacy Scale (ASES-8)
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Health Assessment Questionnaire (HAQ)
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up
Laboratory indicators (RF, CRP, complete blood count)
Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 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 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Exercise Prescription, education and basic joint mobility exercises and paper-based exercise prescription in people with Rheumatoid Arthritis (RA), run by Peking University Third Hospital 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 1 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 24 Nov 2025. 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 yansong li (86-010-88316683, 568475833@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee flexion range of motion (time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 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 24 Nov 2025.