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Идёт набор NCT06642948

AI-based Skeleton Recognition System for Rehabilitation Exercise in Breast Cancer Survivors: A Randomized Controlled Trial

Без фазы С лечением Musculoskeletal Symptoms Breast Cancer Endocrine Therapy Aromatase Inhibitors

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: Motor rehabilitation based on ai visual recognition.
Кому может быть актуально
Состояния в реестре: Musculoskeletal Symptoms, Breast Cancer, Endocrine Therapy, Aromatase Inhibitors. Базовые параметры: Без ограничений · 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: A Randomized Controlled Trial

Обзор

This study aims to develop and evaluate an artificial intelligence (AI)-based skeletal recognition system designed to support real-time, interactive rehabilitation exercise (RE programs. The goal is to mitigate musculoskeletal symptoms associated with endocrine therapy in breast cancer survivors.Endocrine therapy remains a cornerstone in the treatment of hormone receptor-positive breast cancer, typically extending over 5 to 10 years. While the therapeutic benefits of endocrine therapy are well established, agents such as aromatase inhibitors frequently induce musculoskeletal symptoms (MS), including joint pain, stiffness (particularly morning stiffness), carpal tunnel syndrome, tenosynovitis, myalgia, and muscle weakness. These symptoms, which may be continuous or intermittent, can affect both central (spine, hips, shoulders) and peripheral joints (elbows, wrists, knees, feet), severely compromising patients' quality of life (QoL). Although physical exercise has been demonstrated to alleviate these symptoms, adherence to adequate exercise regimens remains suboptimal among patients. Furthermore, there is no consensus on the optimal type, duration, or intensity of exercise interventions, and standardized protocols are lacking. Recognizing exercise as a long-term behavior, we are developing a home-based, AI-assisted rehabilitation program tailored to the specific needs of patients undergoing endocrine therapy.

Вмешательства

  • Другое Motor rehabilitation based on ai visual recognition
    Patients in the intervention group will engage in a home-based exercise program in addition to standard rehabilitation guidance. Initially, patients will be provided with exercise materials developed by the intervention team, one-on-one guidance via the AI rehabilitation platform, and a detailed explanation of the exercise intervention program (including its components, foundational knowledge, and benefits).The aerobic warm-up routine includes activities such as marching in place, full-body stre

Первичные конечные точки

  • Grip strength [Срок оценки: From enrollment to the end of treatment at 12 weeks]
  • M-SACRAH [Срок оценки: From enrollment to the end of treatment at 12 weeks]
  • WOMAC [Срок оценки: From enrollment to the end of treatment at 12 weeks]
  • ROM [Срок оценки: From enrollment to the end of treatment at 12 weeks]
Вторичные конечные точки (7)
  • BCTQ [Срок оценки: From enrollment to the end of treatment at 12 weeks]
  • CRP [Срок оценки: Baseline and 3 months]
  • rheumatoid factor [Срок оценки: Baseline and 3 months]
  • 25-hydroxyvitamin D [Срок оценки: Baseline and 3 months]
  • IL-1、INF-a、IL-6、IFN-a、IFN-Y [Срок оценки: Baseline and 3 months]
  • Bone mineral density [Срок оценки: baseline]
  • OPG/RANKLE SNP [Срок оценки: baseline]

Критерии участия

Критерии включения

  • 1\. Pathologically confirmed hormone receptor-positive breast cancer (stage I, II, III).

2\. Initiation of treatment with aromatase inhibitors (e.g., anastrozole, letrozole, exemestane).

3\. Postmenopausal women, including those with surgically induced menopause. 4. Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.

5\. Informed consent obtained, with voluntary participation in the study. 6. Bone and joint symptoms with a Brief Pain Inventory (BPI) score of ≥3, or presence of at least one of the following risk factors: elevated bone turnover markers, reduced vitamin D levels, increased inflammatory cytokines, elevated C-reactive protein, or elevated rheumatoid factor.

7\. Not participating in any physical therapy or exercise-based interventions that may interfere with this study.

Критерии исключения

\- 1. Recurrence of breast cancer or distant metastasis. 2. Presence of other malignancies. 3. Diagnosed rheumatoid arthritis, bone and joint trauma, or other severe bone and joint diseases.

4\. Bone mineral density T-score <-2.5. 5. Presence of absolute contraindications to exercise.

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
Поддерживающая терапия

Центры проведения

Китай · 1 центр
  • Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06642948 · 13825489001123 · 82272922

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗