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Набор скоро начнётся NCT07246811

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

Без фазы С лечением Rheumatoid Arthritis (RA)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AI Exercise Prescription, education and basic joint mobility exercises, paper-based exercise prescription.
Кому может быть актуально
Состояния в реестре: Rheumatoid Arthritis (RA). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Knee flexion range of motion [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
Вторичные конечные точки (12)
  • Hospital for Special Surgery (HSS) Score [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Timed Up and Go (TUG) Test [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Berg Balance Scale (BBS) [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Isokinetic Muscle Strength Test [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Gait and Plantar Pressure Analysis [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Arthritis Self-Efficacy Scale (ASES-8) [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Health Assessment Questionnaire (HAQ) [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]
  • Laboratory indicators (RF, CRP, complete blood count) [Срок оценки: Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Department of Rehabilitation Medicine, Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07246811 · 2025-q003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗