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Not yet recruiting NCT07246811

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

No phase Interventional Rheumatoid Arthritis (RA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI Exercise Prescription, education and basic joint mobility exercises, paper-based exercise prescription.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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

Primary outcome measures

  • Knee flexion range of motion [Time frame: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Rehabilitation Medicine, Peking University People's Hospital — Beijing

Identifiers

NCT: NCT07246811 · 2025-q003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗