AI-based Skeleton Recognition System for Rehabilitation Exercise in Breast Cancer Survivors: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Motor rehabilitation based on ai visual recognition.
- Who it may be relevant to
- Registry conditions: Musculoskeletal Symptoms, Breast Cancer, Endocrine Therapy, Aromatase Inhibitors. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: A Randomized Controlled Trial
Overview
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.
Interventions
- Other 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
Primary outcome measures
- Grip strength [Time frame: From enrollment to the end of treatment at 12 weeks]
- M-SACRAH [Time frame: From enrollment to the end of treatment at 12 weeks]
- WOMAC [Time frame: From enrollment to the end of treatment at 12 weeks]
- ROM [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (7)
- BCTQ [Time frame: From enrollment to the end of treatment at 12 weeks]
- CRP [Time frame: Baseline and 3 months]
- rheumatoid factor [Time frame: Baseline and 3 months]
- 25-hydroxyvitamin D [Time frame: Baseline and 3 months]
- IL-1、INF-a、IL-6、IFN-a、IFN-Y [Time frame: Baseline and 3 months]
- Bone mineral density [Time frame: baseline]
- OPG/RANKLE SNP [Time frame: baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
\- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06642948 · 13825489001123 · 82272922