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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFudan University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Motor rehabilitation based on ai visual recognition

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Exercise groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Grip strength

Time frame
From enrollment to the end of treatment at 12 weeks
2

M-SACRAH

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

Time frame
From enrollment to the end of treatment at 12 weeks
3

WOMAC

Western Ontario and McMaster Osteoarthritis Index

Time frame
From enrollment to the end of treatment at 12 weeks
4

ROM

range of motion

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

Secondary outcomes

1

BCTQ

Boston Carpal Tunnel Syndrome Questionnaire

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

Other outcomes

Sponsors and contacts

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