Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 82272922 | Other Grant/Funding Number | National Natural Science Foundation of China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | Patients in the intervention group will engage in a home-based exercise program in addition to standard rehabilitation guidance. |
|
| Control group | No Intervention | Patients will receive guidance on breast cancer endocrine therapy-related knowledge, including exercise rehabilitation for bone and joint symptoms (including the freedom to choose the form, type, and intensity of exercise), psychological counseling, and health education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor rehabilitation based on ai visual recognition | Other | 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 stretches, jumping jacks, side steps with arm circles, and squats with alternating punches. For the elderly, the warm-up routine is similar but also incorporates chest expansion exercises, abduction exercises, overhead reaches, lateral movements, hip extension exercises, calf raises, and additional full-body stretches.Functional training should be done 3 to 5 times per week at an intensity of RPE 3 to 4, with each session lasting 15 to 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Grip strength | From enrollment to the end of treatment at 12 weeks | |
| M-SACRAH | score for assessment and quantification of chronic rheumatic affections of the hands | From enrollment to the end of treatment at 12 weeks |
| WOMAC | Western Ontario and McMaster Osteoarthritis Index | From enrollment to the end of treatment at 12 weeks |
| ROM | range of motion | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BCTQ | Boston Carpal Tunnel Syndrome Questionnaire | From enrollment to the end of treatment at 12 weeks |
| CRP | Baseline and 3 months | |
Not provided
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.
Participant eligibility is based on self-representation of gender identity.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingyun Jiang | Contact | (+86) 18359374969 | 22211170029@m.fudan.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Cancer Center | Recruiting | Shanghai | China |
There is no plan to make individual participant data available to other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| rheumatoid factor |
| Baseline and 3 months |
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided