Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Grip strength
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed hormone receptor-positive breast cancer (stage I, II, III).
- •Initiation of treatment with aromatase inhibitors (e.g., anastrozole, letrozole, exemestane).
- •Postmenopausal women, including those with surgically induced menopause.
- •Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.
- •Informed consent obtained, with voluntary participation in the study.
- •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.
- •Not participating in any physical therapy or exercise-based interventions that may interfere with this study.
排除标准
- •Recurrence of breast cancer or distant metastasis.
- •Presence of other malignancies.
- •Diagnosed rheumatoid arthritis, bone and joint trauma, or other severe bone and joint diseases.
- •Bone mineral density T-score <-2.
- •Presence of absolute contraindications to exercise.
结局指标
主要结局
Grip strength
时间窗: From enrollment to the end of treatment at 12 weeks
M-SACRAH
时间窗: From enrollment to the end of treatment at 12 weeks
score for assessment and quantification of chronic rheumatic affections of the hands
WOMAC
时间窗: From enrollment to the end of treatment at 12 weeks
Western Ontario and McMaster Osteoarthritis Index
ROM
时间窗: From enrollment to the end of treatment at 12 weeks
range of motion
次要结局
- 25-hydroxyvitamin D(Baseline and 3 months)
- IL-1、INF-a、IL-6、IFN-a、IFN-Y(Baseline and 3 months)
- Bone mineral density(baseline)
- OPG/RANKLE SNP(baseline)
- BCTQ(From enrollment to the end of treatment at 12 weeks)
- CRP(Baseline and 3 months)
- rheumatoid factor(Baseline and 3 months)
研究者
Jiang Lingyun
Principal Investigator
Fudan University