Artificial Intelligence (AI)-Based Personalized Exercise Coaching for Patients With Breast Cancer

NCT07844941 | Recruiting

• 1 other identifier: RJBC-AISport
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Exercise; Artificial Intelligence; Digital Health; Physical Activity; Exercise Adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (10)

• Change in Health-Related Quality of Life

  Baseline, 3 months, and 6 months

• Change in Anxiety Symptoms

  Baseline, 3 months, and 6 months

• Change in Depressive Symptoms

  Baseline, 3 months, and 6 months

• Change in Peak Oxygen Uptake

  Baseline, 3 months, and 6 months

• Change in Muscle Strength

  Baseline, 3 months, and 6 months

Study Arms (2)

The AI-Based Exercise Coaching Group

EXPERIMENTAL

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.

Device: AI-Based Personalized Exercise Coaching

The Control Group

ACTIVE COMPARATOR

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.

Behavioral: Conventional Exercise Guidance

Interventions

AI-Based Personalized Exercise Coaching DEVICE

Participants 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.

The AI-Based Exercise Coaching Group

Conventional Exercise Guidance BEHAVIORAL

General exercise recommendations will be provided by healthcare professionals according to routine clinical practice.

The Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Siji Zhu, MD

CONTACT

021-64370045; zsj_mu@yeah.net

Xiaosong Chen, Professor

CONTACT

021-64370045; chenxiaosong0156@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 28, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): March 22, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)