Rehabilitation Exercise Intervention for Rheumatoid Arthritis Patients Using Artificial Intelligence-Based Exercise Prescription System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Knee flexion range of motion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Routine Care Group
Receives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses.
干预措施: education and basic joint mobility exercises (Other)
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.
干预措施: paper-based exercise prescription (Other)
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.
干预措施: AI Exercise Prescription (Other)
结局指标
主要结局
Knee flexion range of motion
时间窗: 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.
次要结局
- 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)
- Timed Up and Go (TUG) Test(Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(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)
- 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)
- Arthritis Self-Efficacy Scale (ASES-8)(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)
- 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)
- Hospital for Special Surgery (HSS) Score(Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up)