Artificial Intelligence (AI)-Based Personalized Exercise Coaching for Patients With Breast Cancer
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Xiaosong Chen, Professor
- Telefonní číslo: 021-64370045
- E-mail: chenxiaosong0156@hotmail.com
Studijní záloha kontaktů
- Jméno: Siji Zhu, MD
- Telefonní číslo: 021-64370045
- E-mail: zsj_mu@yeah.net
Studijní místa
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200025
- Nábor
- Ruijin Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
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. |
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Aktivní komparátor: 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. |
General exercise recommendations will be provided by healthcare professionals according to routine clinical practice. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Exercise Adherence
Časové okno: 6 months
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Health-Related Quality of Life
Časové okno: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
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Change in Anxiety Symptoms
Časové okno: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
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Change in Depressive Symptoms
Časové okno: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
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Change in Peak Oxygen Uptake
Časové okno: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
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Change in Muscle Strength
Časové okno: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
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Change in Joint Range of Motion
Časové okno: Baseline, 3 months, and 6 months
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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 (°). |
Baseline, 3 months, and 6 months
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Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Časové okno: Baseline, 3 months, and 6 months
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Low-density lipoprotein cholesterol will be measured from fasting venous blood samples using an automatic biochemical analyzer. The unit of measurement is mmol/L. |
Baseline, 3 months, and 6 months
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Change in Total Cholesterol
Časové okno: Baseline, 3 months, and 6 months
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Total cholesterol will be measured from fasting venous blood samples using an automatic biochemical analyzer. The unit of measurement is mmol/L. |
Baseline, 3 months, and 6 months
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Change in Fasting C-Peptide
Časové okno: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
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Incidence of Exercise-Related Adverse Events
Časové okno: From baseline through 6 months
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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 (%). |
From baseline through 6 months
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RJBC-AISport
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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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