Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: a Pilot Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- WOMAC
研究概览
简要总结
Endocrine therapy represents a foundational approach for managing hormone receptor-positive breast cancer, with treatment typically spanning 5 to 10 years. Although its clinical efficacy is well-established, medications like aromatase inhibitors frequently result in musculoskeletal (MS) complications, such as joint discomfort, stiffness (especially in the morning), carpal tunnel syndrome, tenosynovitis, myalgia, and reduced muscle strength. These issues, which can manifest intermittently or persistently, impact both central joints (spine, hips, shoulders) and peripheral ones (elbows, wrists, knees, feet), thereby substantially diminishing patients' quality of life (QoL). Evidence suggests that physical activity can mitigate these symptoms; however, adherence to exercise routines remains insufficient. Moreover, there is no agreement regarding the most effective type, intensity, or duration of exercise, and standardized guidelines are absent. Acknowledging the need for exercise as a sustainable habit, this research aims to design a home-based rehabilitation program customized for individuals 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)
盲法说明
Outcomes assessors will be blinded to participant group assignments to ensure unbiased evaluation of study endpoints. Group allocation will be securely randomized, with access restricted to personnel uninvolved in assessments. Assessors will interact with participants following standardized protocols and receive de-identified data to prevent unintentional unmasking. Study staff will be trained to avoid disclosing treatment allocation during interactions. Any breach of masking will be documented, and corrective actions, such as reassignment or bias evaluation, will be implemented to maintain data integrity.
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
WOMAC
时间窗: Baseline and 1month
Developed in 1988 by Bellamy and Buchanan, the WOMAC index evaluates pain, stiffness, and physical function in knee or hip osteoarthritis patients over the past 48 hours . The WOMAC 3.1 version contains 24 items scored using either a VAS (0-100 mm) or a 5-point Likert scale (0-4). This study will use the VAS version, with pain (5 items, 0-500 points), stiffness (2 items, 0-200 points), and physical function (17 items, 0-1700 points) subscales. Total scores range from 0 to 2400, with higher scores indicating greater symptom burden. Scores below 800 denote mild symptoms, 800-1200 moderate, and above 1200 severe symptoms.
Grip strength
时间窗: Baseline and 1month
Grip strength will be measured by the exercise group at baseline (0 months) and at 1, 3, and 6 months of intervention. An electronic hand dynamometer (CAMRY EH10) will be used for assessment. Participants will perform the test by extending their arms straight down with their palms facing their thighs, abducting their dominant upper limb (on the non-surgical side) by 30 degrees. The grip strength value, displayed in kilograms on the dynamometer, will represent the maximum force achieved. To ensure accuracy, participants will be instructed not to swing their arms, squat, or allow the dynamometer to touch their body during the test. Each participant will undergo three assessments, with a 60-second interval between measurements, and the highest value will be used for analysis.
M-SACRAH
时间窗: Baseline and 1month
The SACRAH, developed by Leeb et al. in 2003, is a validated tool for assessing chronic rheumatic hand conditions. The Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH), a shorter and simplified version of SACRAH, has shown similar reliability and representativeness. M-SACRAH contains 12 items scored using a visual analog scale (VAS, 0-100 mm) across three dimensions: pain (2 items, 0-200 points), stiffness (2 items, 0-200 points), and physical function (8 items, 0-800 points). Higher scores indicate more severe symptoms, with a total possible score of 0-1200.
BCTQ
时间窗: Baseline and 1month
The BCTQ consists of 11 items assessing symptom severity (Symptom Severity Score, SSS) and 8 items evaluating functional status (Function Scale Score, FSS) . The SSS addresses issues such as nocturnal pain, frequency of night awakenings, daytime wrist pain, hand numbness or weakness, and difficulty handling small objects. The FSS evaluates activities like writing, buttoning clothes, carrying groceries, and performing household tasks. Each item is rated on a 5-point scale, with 1 indicating "none" and 5 indicating "severe." The average score across all items represents the final score.
Range of Motion
时间窗: Baseline and 1month
Tools for ROM measurement include goniometers, rulers, and electronic measuring devices. The goniometer comprises a stationary arm (proximal arm) with a semicircular (0°-180°) or circular (0°-360°) angle scale and a movable arm (distal arm) attached via a rivet. The movable arm rotates with the limb, allowing ROM to be read from the scale.
次要结局
未报告次要终点
研究者
Lingyun Jiang
Principal Investigator
Fudan University