Actively Recruiting

Phase Not Applicable
All Genders
ID06642948

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

All Genders

Eligibility Criteria

Eligible

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
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 less than -2.5
  • Absolute contraindications to exercise

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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