Breast CancerNCT07844941
Artificial Intelligence (AI)-Based Personalized Exercise Coaching for Patients With Breast Cancer
A study testing AI-Based Personalized Exercise Coaching and Conventional Exercise Guidance in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- AI-Based Personalized Exercise Coaching and Conventional Exercise Guidance
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2026to 22 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- AI-Based Personalized Exercise Coaching, Conventional Exercise Guidance
- Keywords
- Breast Cancer, Exercise, Artificial Intelligence, Digital Health, Physical Activity, Exercise Adherence
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Based Personalized Exercise CoachingDevice
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.
Conventional Exercise GuidanceBehavioural
General exercise recommendations will be provided by healthcare professionals according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conventional Exercise Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (10)
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
Change in Muscle Strength
Muscle strength of upper- and lower-extremity groups will be assessed bilaterally by manual muscle testing (MMT) using the Medical Research Council (MRC) 0-5 grading scale. The unit of measurement is MRC muscle grade (0-5). Higher grades indicate greater muscle strength.
Measured: Baseline, 3 months, and 6 months
Change in Joint Range of Motion
Active and passive joint range of motion (AROM and PROM) of the shoulder, elbow and wrist will be measured using a universal goniometer, on both left and right sides. The unit of measurement is degrees (°).
Measured: Baseline, 3 months, and 6 months
Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Low-density lipoprotein cholesterol will be measured from fasting venous blood samples using an automatic biochemical analyzer. The unit of measurement is mmol/L.
Measured: Baseline, 3 months, and 6 months
Change in Total Cholesterol
Total cholesterol will be measured from fasting venous blood samples using an automatic biochemical analyzer. The unit of measurement is mmol/L.
Measured: Baseline, 3 months, and 6 months
Change in Fasting C-Peptide
Fasting C-peptide will be measured from venous blood samples collected after at least 8 hours of overnight fasting, using a chemiluminescent immunoassay analyzer. The unit of measurement is ng/mL.
Measured: Baseline, 3 months, and 6 months
Incidence of Exercise-Related Adverse Events
The number and proportion (%) of participants experiencing exercise-related adverse events, including muscle strain, joint sprain, falls, and other exercise-related injuries, will be recorded during the intervention period. The outcome is reported as the percentage of participants with at least one exercise-related adverse event. The unit of measurement is percentage (%).
Measured: From baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start22 Jul 2026
- Primary completion22 Mar 2027 (estimated)
- Study completion22 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844941
- Sponsor's protocol ID
- RJBC-AISport
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07844941
- Acronym / sponsor ID
- RJBC-AISport
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Exercise, Artificial Intelligence, Digital Health, Physical Activity, Exercise Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 22 Mar 2027 (estimated)
- Study completion
- 22 Mar 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The AI-Based Exercise Coaching Group | Experimental | Device: AI-Based Personalized Exercise CoachingParticipants 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. |
| The Control Group | Active comparator | Behavioral: Conventional Exercise GuidanceParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Based Personalized Exercise CoachingParticipants 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. | Device | The AI-Based Exercise Coaching Group |
| Conventional Exercise GuidanceGeneral exercise recommendations will be provided by healthcare professionals according to routine clinical practice. | Behavioural | The Control Group |
Primary outcome
Exercise Adherence
Time frame: 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.
10 secondary outcomes
Change in Health-Related Quality of Life
Time frame: Baseline, 3 months, and 6 months
Change in Anxiety Symptoms
Time frame: Baseline, 3 months, and 6 months
Change in Depressive Symptoms
Time frame: Baseline, 3 months, and 6 months
Change in Peak Oxygen Uptake
Time frame: Baseline, 3 months, and 6 months
Change in Muscle Strength
Time frame: Baseline, 3 months, and 6 months
Change in Joint Range of Motion
Time frame: Baseline, 3 months, and 6 months
Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, 3 months, and 6 months
Change in Total Cholesterol
Time frame: Baseline, 3 months, and 6 months
Change in Fasting C-Peptide
Time frame: Baseline, 3 months, and 6 months
Incidence of Exercise-Related Adverse Events
Time frame: From baseline through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Based Personalized Exercise Coaching and Conventional Exercise Guidance in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siji Zhu, MD (021-64370045, zsj_mu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.