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

NCT ID: NCT06642948

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2025-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise group

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

Group Type: EXPERIMENTAL

Motor rehabilitation based on ai visual recognition

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motor 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.

Intervention Type: OTHER

Other Intervention Names

ai visual recognition technology; exercise

Eligibility Criteria

Inclusion Criteria

• 1. Pathologically confirmed hormone receptor-positive breast cancer (stage I, II, III).

2. Initiation of treatment with aromatase inhibitors (e.g., anastrozole, letrozole, exemestane).

3. Postmenopausal women, including those with surgically induced menopause. 4. Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.

5. 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.

7. 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.

4. Bone mineral density T-score <-2.5. 5. Presence of absolute contraindications to exercise.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jiang Lingyun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lingyun Jiang

Role: CONTACT

22211170029@m.fudan.edu.cn

(+86) 18359374969

Facility Contacts

Lingyun Jiang

Role: primary

22211170029@m.fudan.edu.cn

（086）18359374969

Other Identifiers

82272922

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

13825489001123

Identifier Type: -

Identifier Source: org_study_id