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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Exercise Adherence
研究概览
简要总结
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.
详细描述
Regular physical activity is recommended for patients with cancer and may improve physical function, psychological well-being, and quality of life. However, conventional exercise guidance may be limited by insufficient personalization, limited professional resources, and difficulties in continuously monitoring exercise behavior.
The AI-based exercise coaching system evaluated in this study is designed to provide personalized exercise recommendations and dynamically adjust exercise guidance based on individual characteristics and exercise data. The system integrates exercise-related knowledge and uses wearable devices to collect exercise data for monitoring and feedback.
This study is a prospective, single-center, open-label, randomized controlled trial conducted among female patients with breast cancer who have completed major cancer treatment and are clinically stable. One hundred eligible participants will be randomized in a 1:1 ratio to the AI-based exercise coaching group or the conventional exercise guidance group.
Participants assigned to the AI-based exercise coaching group will follow individualized exercise programs generated by the system and will upload exercise data to enable dynamic guidance and adjustment. Participants assigned to the control group will receive general exercise recommendations from healthcare professionals.
The intervention period will be 6 months. Assessments will be conducted at baseline, 3 months, and 6 months. The primary outcome will be exercise adherence. Secondary outcomes will include quality of life, psychological status, physical function, exercise-related safety outcomes, and laboratory and metabolic parameters.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 支持治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 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.
排除标准
- 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.
研究组 & 干预措施
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.
干预措施: AI-Based Personalized Exercise Coaching (Device)
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.
干预措施: Conventional Exercise Guidance (Behavioral)
结局指标
主要结局
Exercise Adherence
时间窗: 6 months
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.
次要结局
- 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)
- Change in Joint Range of Motion(Baseline, 3 months, and 6 months)
- Change in Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline, 3 months, and 6 months)
- Change in Total Cholesterol(Baseline, 3 months, and 6 months)
- Change in Fasting C-Peptide(Baseline, 3 months, and 6 months)
- Incidence of Exercise-Related Adverse Events(From baseline through 6 months)
研究者
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine
研究点 (1)
标识符
- NCT 编号
- NCT07844941
- 其他研究编号
- RJBC-AISport
日期
- 首次提交
- (18天前)
- 首次发布
- (前天)
- 主要完成日期
- (5个月后)
- 研究完成日期
- (5个月后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
De-identified individual participant data collected in this study will not be shared with external researchers, as the data contain sensitive health information from breast cancer survivors and are intended solely for the primary research group's analyses.