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

November 20, 2025 updated by: Peking University Third Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Department of Rehabilitation Medicine, Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Routine Care Group
Receives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses.
Other: education and basic joint mobility exercises
Receives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses.
Active Comparator: Paper Exercise Prescription Group
Receives 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-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.
Experimental: AI Exercise Prescription Group
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.
Other: AI 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

August 11, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-q003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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