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Effect of an Artificial Intelligence-Based Personalized Exercise Coaching System on Exercise Adherence and Quality of Life in Patients With Breast Cancer: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

• No severe cardiopulmonary dysfunction or contraindications to exercise.

Locations
Other Locations
China
Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Siji Zhu, MD
zsj_mu@yeah.net
021-64370045
Backup
Xiaosong Chen, Professor
chenxiaosong0156@hotmail.com
021-64370045
Time Frame
Start Date: 2026-07-22
Estimated Completion Date: 2027-03-22
Participants
Target number of participants: 60
Treatments
Experimental: The AI-Based Exercise Coaching Group
Participants assigned to this group will use an AI-based exercise coaching system for 6 months. The system will generate individualized exercise recommendations based on participant characteristics and health-related information. Exercise data will be collected and uploaded to the system, allowing exercise recommendations to be dynamically adjusted according to participants' exercise performance and status. Participants will also receive regular follow-up during the intervention period.
Active_comparator: The Control Group
Participants assigned to the control group will receive conventional exercise guidance from healthcare professionals based on routine clinical practice and professional experience, including general recommendations such as approximately 150 minutes of moderate-intensity aerobic exercise per week. Participants will receive regular follow-up during the 6-month study period.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov