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NCT Number: NCT06642948

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

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.

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Key information

Conditions

Musculoskeletal Symptoms Aromatase Inhibitors Breast Cancer Breast Diseases Breast Neoplasms Endocrine Therapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Cancer Center

Shanghai, China

Location status: Recruiting

Location contact

Lingyun Jiang

CONTACT

[email protected]

（086）18359374969

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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. 4. Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.
  • 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.
  • 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.
  • Bone mineral density T-score <-2.5. 5. Presence of absolute contraindications to exercise.

Treatment and study plan

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.

Other names: ai visual recognition technology, exercise

Primary outcomes

  1. Grip strength

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. M-SACRAH

    Time frame: From enrollment to the end of treatment at 12 weeks

    score for assessment and quantification of chronic rheumatic affections of the hands

  3. WOMAC

    Time frame: From enrollment to the end of treatment at 12 weeks

    Western Ontario and McMaster Osteoarthritis Index

  4. ROM

    Time frame: From enrollment to the end of treatment at 12 weeks

    range of motion

Secondary outcomes

  1. BCTQ

    Time frame: From enrollment to the end of treatment at 12 weeks

    Boston Carpal Tunnel Syndrome Questionnaire

  2. CRP

    Time frame: Baseline and 3 months

  3. rheumatoid factor

    Time frame: Baseline and 3 months

  4. 25-hydroxyvitamin D

    Time frame: Baseline and 3 months

  5. IL-1、INF-a、IL-6、IFN-a、IFN-Y

    Time frame: Baseline and 3 months

  6. Bone mineral density

    Time frame: baseline

  7. OPG/RANKLE SNP

    Time frame: baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Lingyun Jiang

CONTACT

[email protected]

(+86) 18359374969

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Acronym: AiRE-MS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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