Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Wireless Wearable Vital Sign and Activity Monitor, Digital Postoperative Rehabilitation Program, Standard Postoperative Rehabilitation Education.
- Кому может быть актуально
- Состояния в реестре: Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery. Базовые параметры: 18 лет — 85 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Clinical Trial of Postoperative Rehabilitation for Non-Small Cell Lung Cancer Based on Wireless Wearable Mobile Monitoring Devices
Обзор
This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial evaluating whether a wireless wearable mobile monitoring device combined with a digital rehabilitation program improves pulmonary function at 90 days postoperatively in patients undergoing curative-intent lobectomy or segmentectomy for non-small cell lung cancer (NSCLC). Eligible participants will be randomized to either the intervention group or the control group. Both groups receive standard postoperative rehabilitation education. The intervention group additionally receives a wearable device (chest patch or wristband) for continuous monitoring of SpO₂, heart rate, respiratory rate, and physical activity, along with a smartphone-based digital rehabilitation program including individualized exercise prescriptions (aerobic, resistance, and inspiratory muscle training), daily symptom diaries, and remote feedback with threshold-triggered alerts for up to 90 days after discharge. The control group receives standard rehabilitation education with routine follow-up. The primary endpoint is the between-group difference in FEV1% predicted at postoperative day 90, analyzed using ANCOVA adjusted for baseline FEV1% predicted. Secondary endpoints include FVC% predicted, 6-minute walk distance, daily step count, SpO₂ \<90% time burden, quality of life (EORTC QLQ-C30/LC13, mMRC), 90-day readmission and emergency visit rates, and safety outcomes. A total of 126 participants (63 per group) will be enrolled. The study is being conducted at West China Hospital of Sichuan University from June 2026 to October 2027.
Подробное описание
Study Design
This is a prospective, single-center, parallel-group, 1:1 randomized controlled superiority trial conducted at West China Hospital of Sichuan University. Enrollment is planned from June 2026 to August 2027, with final data analysis by October 2027. The study protocol has been approved by the local ethics committee (Approval No. 2025-2643, dated December 30, 2025).
Study Population
We will enroll 126 patients aged 18-85 years with histopathologically confirmed primary NSCLC who have undergone elective curative-intent lobectomy or segmentectomy. Eligible participants must be planned for discharge between postoperative days 2-7, clinically stable for home-based rehabilitation, and able to operate a smartphone and wearable devices independently or with caregiver assistance.
Randomization and Blinding
Participants are randomized 1:1 using a central web-based block randomization system. This is a single-blind trial: participants and rehabilitation instructors are aware of group assignment, but outcome assessors (pulmonary function technicians, 6MWD operators) and statisticians are blinded to group allocation.
Intervention
Control group receives standard postoperative rehabilitation education, including breathing exercises and progressive walking recommendations, with routine follow-up at 1 month and 3 months.
Intervention group receives, in addition to standard education: (1) a wireless wearable patch or wristband for continuous monitoring of SpO₂, single-lead ECG, respiratory rate, and activity data; (2) a smartphone-based digital rehabilitation program with individualized exercise prescriptions (aerobic, resistance, and inspiratory muscle training) and daily symptom diaries; and (3) remote feedback and threshold-triggered alerts (e.g., SpO₂ \<90% for \>1 minute) with graded clinical responses.
Follow-up and Assessments
The observation period spans from discharge to postoperative day 90. Assessments include pulmonary function tests (FEV1%, FVC%, FEV1/FVC), 6-minute walk distance, quality of life (EORTC QLQ-C30/LC13, mMRC), continuous physiological monitoring (intervention group only), adherence metrics, and healthcare utilization (readmissions, ED visits, complications).
Primary Endpoint
The primary endpoint is the FEV1% predicted at postoperative day 90 (±14 days), analyzed by ANCOVA with baseline FEV1% predicted as covariate.
Sample Size
With two-sided α=0.05, 80% power, an expected between-group difference of 7% in FEV1% predicted, and a pooled standard deviation of 12%, 53 participants per group are required. Accounting for 18% dropout, the final sample size is 126 (63 per group).
Statistical Analysis
Primary analysis will be performed on the intention-to-treat population using ANCOVA. Secondary continuous endpoints will be analyzed using ANCOVA or repeated-measures ANOVA; categorical endpoints using chi-square or Fisher's exact test. Safety outcomes will be summarized descriptively. A two-sided p-value \<0.05 is considered statistically significant.
Safety and Data Quality
Adverse events are graded per CTCAE v5.0. Serious adverse events are reported within 24 hours. All study personnel follow standardized operating procedures, and electronic data capture with dual entry and logic checks ensures data quality.
Ethics and Dissemination
The study is conducted in accordance with the Declaration of Helsinki and Chinese regulations. Written informed consent will be obtained from all participants. Results will be published regardless of outcome.
Вмешательства
- Устройство Wireless Wearable Vital Sign and Activity Monitor
Wireless wearable chest patchs or wristband integrating SpO₂, single-lead ECG, respiratory rate, and accelerometer sensors for continuous monitoring of vital signs and physical activity during daily living. - Поведенческое Digital Postoperative Rehabilitation Program
A 90-day home-based digital rehabilitation program delivered via smartphone application, including individualized exercise prescriptions (aerobic walking, resistance training with elastic bands, inspiratory muscle training), daily symptom diaries (cough, sputum, dyspnea), and remote feedback with threshold-triggered alerts and weekly telehealth follow-ups. - Другое Standard Postoperative Rehabilitation Education
Standardized verbal and written postoperative rehabilitation education including breathing exercises (abdominal breathing, pursed-lip breathing, effective coughing), progressive walking recommendations, and routine outpatient follow-up at 1 month and 3 months per institutional practice.
Первичные конечные точки
- FEV1% Predicted at Postoperative Day 90 [Срок оценки: Postoperative day 90 (±14 days)]
Вторичные конечные точки (12)
- FVC% Predicted at Postoperative Day 90 [Срок оценки: Postoperative day 90 (±14 days)]
- FEV1/FVC Ratio at Postoperative Day 90 [Срок оценки: Postoperative day 90 (±14 days)]
- 6-Minute Walk Distance at Postoperative Day 90 [Срок оценки: Postoperative day 90 (±14 days)]
- Daily Step Count [Срок оценки: Continuous from discharge to postoperative day 90 (intervention group only)]
- Moderate-to-Vigorous Physical Activity (MVPA) Duration [Срок оценки: Continuous from discharge to postoperative day 90 (intervention group only)]
- Time Proportion with SpO₂ Below 90% [Срок оценки: Continuous from discharge to postoperative day 90 (intervention group only)]
- Mean SpO₂ and Lowest SpO₂ [Срок оценки: Continuous from discharge to postoperative day 90 (intervention group only)]
- EORTC QLQ-C30 Global Health Status Score [Срок оценки: Baseline (pre-discharge) and postoperative day 90]
- EORTC QLQ-LC13 Lung Cancer Module Scores [Срок оценки: Baseline (pre-discharge) and postoperative day 90]
- mMRC Dyspnea Scale Score [Срок оценки: Baseline (pre-discharge) and postoperative day 90]
- 90-Day Unplanned Readmission Rate [Срок оценки: Within 90 days after surgery]
- 90-Day Emergency Department Visit Rate [Срок оценки: Within 90 days after surgery]
Критерии участия
Критерии включения
- Age ≥18 and ≤85 years
- Histopathologically confirmed primary non-small cell lung cancer (NSCLC) who have undergone elective curative-intent lobectomy or segmentectomy
- Planned discharge between postoperative day 2 and day 7, and judged by the investigator to be clinically stable and suitable for home-based rehabilitation
- Able to operate a smartphone application and wearable devices independently or with caregiver assistance
- Willing and able to provide written informed consent
Критерии исключения
- Pre-existing long-term home oxygen therapy, or severe resting respiratory dysfunction
- Concurrent severe, uncontrolled cardiovascular disease, severe hepatic insufficiency, or severe renal insufficiency
- Other diseases or conditions that significantly affect motor function or compliance
- Known or suspected contact allergy to medical adhesives or materials used in the wearable devices
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- West China Hospital — Чэнду
Идентификаторы
NCT: NCT07733492 · 2025(2643)