Actively Recruiting
Evaluating Structured Exercise to Reduce Aromatase Inhibitor-Induced Joint Pain in Breast Cancer Survivors: A Randomized Controlled Trial
Led by Fudan University · Updated on 2024-10-15
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an artificial intelligence (AI)-based skeletal recognition system designed to support real-time, interactive rehabilitation exercise programs for breast cancer survivors experiencing musculoskeletal symptoms related to endocrine therapy. This trial focuses on symptoms caused by aromatase inhibitors, such as joint pain, stiffness, and muscle weakness, which can significantly impact quality of life. The study aims to develop a home-based AI-assisted rehabilitation program tailored to improve exercise adherence and alleviate these symptoms. Participants in the intervention group will follow a home-based exercise program alongside standard rehabilitation guidance, including education on endocrine therapy-related bone and joint symptoms, psychological support, and health education. The exercise program includes aerobic warm-up routines and functional training 3 to 5 times per week, with sessions lasting 15 to 30 minutes at a moderate intensity level. The control group will receive no additional intervention beyond standard care. During the 12-week treatment period, researchers will assess outcomes such as grip strength, joint function using M-SACRAH and WOMAC scales, and range of motion. Secondary measures include symptom severity, inflammation markers, vitamin D levels, bone mineral density, and genetic markers at baseline and after 3 months. Participants will be monitored for changes in musculoskeletal symptoms and overall physical function to evaluate the program's impact.
CONDITIONS
Brief Title
AI-based Skeleton Recognition System for Rehabilitation Exercise in Breast Cancer Survivors: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed hormone receptor-positive breast cancer at stage I, II, or III
- Starting treatment with aromatase inhibitors such as anastrozole, letrozole, or exemestane
- Postmenopausal women, including those with surgically induced menopause
- Clear consciousness and ability to communicate and comply with the intervention
- Informed consent given voluntarily
- Bone and joint symptoms with a Brief Pain Inventory score of 3 or higher, or presence of risk factors like elevated bone turnover markers, low vitamin D, increased inflammatory cytokines, elevated C-reactive protein, or rheumatoid factor
- Not currently participating in any physical therapy or exercise programs that could interfere with this study
You will not qualify if you...
- 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 less than -2.5
- Absolute contraindications to exercise
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants engage in a home-based exercise program or receive guidance on exercise rehabilitation, psychological counseling, and health education to manage aromatase inhibitor-induced joint pain.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
L
Lingyun Jiang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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