RecruitingNot ApplicableNCT06642948

AI-based Skeleton Recognition System for Rehabilitation Exercise in Breast Cancer Survivors: A Randomized Controlled Trial

Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: A Randomized Controlled Trial


Sponsor

Fudan University

Enrollment

80 participants

Start Date

Oct 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This trial is testing whether an AI-assisted exercise program using a skeleton recognition system (a camera that tracks your body movements) can reduce joint and bone pain in breast cancer survivors taking aromatase inhibitors. **You may be eligible if...** - You are a postmenopausal woman with hormone receptor-positive breast cancer (stage I, II, or III) - You have recently started taking an aromatase inhibitor (e.g., anastrozole, letrozole, or exemestane) - You have joint or bone pain (BPI score of 3 or higher), or have relevant risk factors such as low vitamin D or elevated inflammation markers - You have clear thinking and no issues that would prevent participation **You may NOT be eligible if...** - Your breast cancer has come back or spread - You have another active cancer - You have rheumatoid arthritis, serious bone/joint injury, or severe bone disease - Your bone density T-score is below -2.5 (indicating osteoporosis) - You have conditions that prevent exercise Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMotor 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 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.


Locations(1)

Shanghai Cancer Center

Shanghai, China

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NCT06642948


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