This prospective, single-center, randomized controlled trial aims to evaluate the effectiveness and safety of an artificial intelligence (AI)-based personalized exercise coaching system in female breast cancer survivors who have completed major cancer treatment and are clinically stable. A total of 100 eligible participants will be randomly assigned in a 1:1 ratio to either an AI-based exercise coaching group or a conventional exercise guidance group. Participants in the intervention group will receive personalized exercise recommendations generated by the AI exercise coaching system, with exercise data collected and used for dynamic adjustment of exercise guidance. Participants in the control group will receive conventional exercise recommendations provided by healthcare professionals. The intervention will last for 6 months. Exercise adherence will be evaluated as the primary outcome. Secondary outcomes will include quality of life, psychological status, physical function, exercise-related adverse events, and laboratory and metabolic parameters.
Provision of written and dated informed consent.
Female participants aged 18 to 70 years.
Pathologically confirmed breast malignancy.
Completion of major cancer treatment, including surgery, chemotherapy, and/or radiotherapy, with clinically stable disease.
Have not undergone breast cancer surgery.
Mental or psychological condition, as judged by the investigator, that would prevent adherence to the intervention or completion of follow-up.
Parallel
AI-Based Personalized Exercise Coaching
DeviceParticipants will receive individualized exercise recommendations generated by an AI-based exercise coaching system. The system provides personalized exercise guidance and uses exercise data collected to monitor exercise performance and dynamically adjust recommendations. The intervention will be delivered for 6 months.
Conventional Exercise Guidance
BehavioralGeneral exercise recommendations will be provided by healthcare professionals according to routine clinical practice.
Exercise Adherence
Exercise adherence will be calculated as the ratio of the participant's actual exercise frequency to the recommended exercise frequency during the intervention period, expressed as a percentage. Exercise adherence will be compared between the AI-based exercise coaching group and the conventional exercise guidance group.
Change in Health-Related Quality of Life
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores will be calculated according to the EORTC scoring procedures, with domain scores transformed to a 0-100 scale. Higher scores on functional scales and global health status indicate better functioning or quality of life, whereas higher scores on symptom scales indicate greater symptom burden.
Change in Anxiety Symptoms
Anxiety symptoms will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The HADS-A score ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms.
Change in Depressive Symptoms
Depressive symptoms will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The HADS-D score ranges from 0 to 21. Higher scores indicate more severe depressive symptoms.
Change in Peak Oxygen Uptake
Peak oxygen uptake (VO₂peak) will be measured by cardiopulmonary exercise testing (CPET) on an electronically braked cycle ergometer, using a CORTEX MetaLyzer 3B-R3 metabolic cart, during a symptom-limited incremental exercise protocol. VO₂peak is recorded at the highest oxygen uptake achieved during the test. The unit of measurement is mL/kg/min.
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