Single-Center Intelligent Pulmonary Rehabilitation After Lung Cancer Surgery

Официальное название

A Randomized Controlled Trial of an Intelligent Pulmonary Function Exercise Device Versus Usual Care for In-Hospital and Home-Based Pulmonary Rehabilitation After Lung Cancer Surgery

Обзор

This study will compare an intelligent pulmonary function exercise device with usual care and natural recovery in patients recovering from lung cancer surgery. After lung cancer surgery, many patients have reduced lung function, shortness of breath, lower exercise tolerance, and a risk of postoperative pulmonary complications. Standard care usually includes postoperative nursing, pain control, coughing and sputum clearance instruction, early mobilization, discharge education, and routine follow-up. However, patients often lack structured guidance, feedback, and monitoring after discharge. Participants in this study will be randomly assigned to one of two groups. One group will use an intelligent pulmonary function exercise device for respiratory training during hospitalization and at home until 30 days after surgery. The prescribed training is two sessions per day, with each session including 30 expiratory training repetitions and 30 inspiratory training repetitions. The device records training completion and related training information and provides reminders and feedback. The other group will receive usual perioperative care, standard discharge education, and natural recovery follow-up without a study-specified respiratory training device or training prescription. The main purpose of the study is to determine whether the intelligent pulmonary function exercise device improves recovery of forced expiratory volume in 1 second, or FEV1, from before surgery to 30 days after surgery. The study will also evaluate lung function at 90 days, symptoms, quality of life, walking capacity, training adherence, and postoperative complications.

Вмешательства

• Устройство Intelligent Pulmonary Function Exercise Device
  A digital pulmonary rehabilitation device used for active inspiratory and expiratory respiratory training. The device records the number of completed training sessions, expiratory and inspiratory repetitions, training parameters, target completion, reminders, and interruptions. Training data are synchronized to the study platform for adherence monitoring and remote follow-up.
• Поведенческое Usual Care and Natural Recovery
  Usual perioperative care includes standard postoperative nursing, analgesia, coughing and sputum clearance instruction, early mobilization, wound and drainage tube management, discharge education, and routine follow-up. No structured pulmonary rehabilitation program assigned by the study team will be provided to the control group.

Первичные конечные точки

• Change in Forced Expiratory Volume in 1 Second From Baseline to 30 Days After Surgery [Срок оценки: Baseline and 30 days after surgery]

Вторичные конечные точки (5)

• Change in FEV1 From Baseline to 90 Days After Surgery [Срок оценки: Baseline and 90 days after surgery]
• Dyspnea-12 Score [Срок оценки: Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery]
• MD Anderson Symptom Inventory-Lung Cancer Module Score [Срок оценки: Baseline, 30 days after surgery, and 90 days after surgery]
• Six-Minute Walk Distance [Срок оценки: Baseline, 30 days after surgery, and 90 days after surgery]
• Postoperative Complications [Срок оценки: Up to 90 days after surgery]

Критерии участия

Критерии включения

• 1\. Age 18 to 75 years. 2. Pathologically confirmed primary non-small cell lung cancer. 3. Scheduled to undergo elective thoracoscopic lobectomy or sublobar resection. 4. Able to understand the study and voluntarily sign written informed consent before surgery.

5\. Able to communicate and complete study assessments and postoperative follow-up.

6\. Able to use a smartphone independently or with assistance from a caregiver for training records.

7\. Good lung re-expansion on postoperative chest imaging. 8. No chest tube drainage or no persistent air leak from chest tube drainage. 9. Clinical stage cT1-T2b, N0-N1, M0, stage IA-IIB. 10. Home environment allows safe training.

Критерии исключения

• 1\. Preoperative measured FEV1 less than 50% of predicted value. 2. Severe cardiopulmonary dysfunction or other conditions judged unsuitable for respiratory training.

3\. Previous thoracic surgery or major thoracic trauma. 4. Significant cognitive impairment or psychiatric disorder that prevents cooperation with the study.

5\. Pregnancy or breastfeeding. 6. Recent severe infection or active pulmonary disease.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07631533 · ES-2025-266-28

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗