About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
1. Preoperative measured FEV1 less than 50% of predicted value. 2. Severe cardiopulmonary dysfunction or other conditions judged unsuitable for respiratory training.
Trial design
Single group
Treatments tested in this trial
Intelligent Pulmonary Function Exercise Device
DeviceA 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.
Usual Care and Natural Recovery
BehavioralUsual 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Forced Expiratory Volume in 1 Second From Baseline to 30 Days After Surgery
Secondary outcomes
Change in FEV1 From Baseline to 90 Days After Surgery
Dyspnea-12 Score
MD Anderson Symptom Inventory-Lung Cancer Module Score
Six-Minute Walk Distance
Locations
Sponsors and contacts
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Jianxing He
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor institution
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