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NCT Number: NCT07246811

Rehabilitation Exercise Intervention for Rheumatoid Arthritis Patients Using Artificial Intelligence-Based Exercise Prescription System

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.

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

Location contact

yansong li

CONTACT

[email protected]

86-010-88316683

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI Exercise Prescription

Other

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 exercises

Other

Receives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses.

paper-based exercise prescription

Other

Receives paper-based exercise prescription developed by rehabilitation therapists, including warm-up, formal training (bridging, modified bird-dog exercise, etc.) and cool-down stretching.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hospital for Special Surgery (HSS) Score

    Time frame: 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

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  3. Timed Up and Go (TUG) Test

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  4. Berg Balance Scale (BBS)

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  5. Isokinetic Muscle Strength Test

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  6. Gait and Plantar Pressure Analysis

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  7. Arthritis Self-Efficacy Scale (ASES-8)

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  8. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  9. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  10. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  11. Health Assessment Questionnaire (HAQ)

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  12. Laboratory indicators (RF, CRP, complete blood count)

    Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

yansong li

CONTACT

[email protected]

86-010-88316683

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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