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

NCT06642948 | Recruiting

• 2 other identifiers: 1382548900112382272922
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Musculoskeletal Symptoms; Breast Cancer; Endocrine Therapy; Aromatase Inhibitors

Outcome Measures

Primary Outcomes (4)

• Grip strength

  From enrollment to the end of treatment at 12 weeks

• M-SACRAH

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

  From enrollment to the end of treatment at 12 weeks

• WOMAC

  Western Ontario and McMaster Osteoarthritis Index

  From enrollment to the end of treatment at 12 weeks

• ROM

  range of motion

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (7)

• BCTQ

  From enrollment to the end of treatment at 12 weeks

• CRP

  Baseline and 3 months

• rheumatoid factor

  Baseline and 3 months

• 25-hydroxyvitamin D

  Baseline and 3 months

• IL-1、INF-a、IL-6、IFN-a、IFN-Y

  Baseline and 3 months

Study Arms (2)

Exercise group

EXPERIMENTAL

Patients in the intervention group will engage in a home-based exercise program in addition to standard rehabilitation guidance.

Other: Motor rehabilitation based on ai visual recognition

Control group

NO INTERVENTION

Patients will receive guidance on breast cancer endocrine therapy-related knowledge, including exercise rehabilitation for bone and joint symptoms (including the freedom to choose the form, type, and intensity of exercise), psychological counseling, and health education.

Interventions

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.

Also known as: ai visual recognition technology, exercise

Exercise group

Eligibility Criteria

• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Lingyun Jiang

CONTACT

(+86) 18359374969; 22211170029@m.fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: October 20, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)