Actively Recruiting

Phase Not Applicable
All Genders
NCT06642948

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

Led by Fudan University · Updated on 2024-10-15

80

Participants Needed

1

Research Sites

10 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 653, or presence of at least one risk factor: 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
Not Eligible

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 < -2.5
  • Presence of absolute contraindications to exercise

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

L

Lingyun Jiang

CONTACT

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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