Rheumatoid Arthritis (RA)
Conditions
Brief 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. 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.
Interventions
OTHEReducation and basic joint mobility exercises
Receives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses.
OTHERAI Exercise Prescription
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.
OTHERpaper-based exercise prescription
Receives paper-based exercise prescription developed by rehabilitation therapists, including warm-up, formal training (bridging, modified bird-dog exercise, etc.) and cool-down stretching.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee flexion range of motion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital for Special Surgery (HSS) Score | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | 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 |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
| Timed Up and Go (TUG) Test | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
| Isokinetic Muscle Strength Test | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
| Gait and Plantar Pressure Analysis | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
| Berg Balance Scale (BBS) | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
| Generalized Anxiety Disorder-7 (GAD-7) | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
| Health Assessment Questionnaire (HAQ) | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
| Laboratory indicators (RF, CRP, complete blood count) | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
| Arthritis Self-Efficacy Scale (ASES-8) | Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up | — |
Countries
China
Contacts
Primary Contactyansong li
Outcome results
None listed