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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Xiaosong Chen, Professor
- Telefonszám: 021-64370045
- E-mail: chenxiaosong0156@hotmail.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Siji Zhu, MD
- Telefonszám: 021-64370045
- E-mail: zsj_mu@yeah.net
Tanulmányi helyek
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kína, 200025
- Toborzás
- Ruijin Hospital
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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. |
|
Aktív összehasonlító: 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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Exercise Adherence
Időkeret: 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. |
6 months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Health-Related Quality of Life
Időkeret: Baseline, 3 months, and 6 months
|
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
|
|
Change in Anxiety Symptoms
Időkeret: Baseline, 3 months, and 6 months
|
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
|
|
Change in Depressive Symptoms
Időkeret: Baseline, 3 months, and 6 months
|
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
|
|
Change in Peak Oxygen Uptake
Időkeret: Baseline, 3 months, and 6 months
|
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
|
|
Change in Muscle Strength
Időkeret: Baseline, 3 months, and 6 months
|
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
|
|
Change in Joint Range of Motion
Időkeret: Baseline, 3 months, and 6 months
|
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
|
|
Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Időkeret: Baseline, 3 months, and 6 months
|
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
|
|
Change in Total Cholesterol
Időkeret: Baseline, 3 months, and 6 months
|
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
|
|
Change in Fasting C-Peptide
Időkeret: Baseline, 3 months, and 6 months
|
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
|
|
Incidence of Exercise-Related Adverse Events
Időkeret: From baseline through 6 months
|
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
|
Együttműködők és nyomozók
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- RJBC-AISport
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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.
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .