Intelligent Pulmonary Rehabilitation After Lung Cancer Surgery

A Multicenter 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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Device: Intelligent Pulmonary Function Exercise Device; Behavioral: Usual Care and Natural Recovery

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianxing He, MD; Phone Number: 020-83062810; Email: jianxinghe@gzhmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Participants will receive usual perioperative care and active respiratory training using an intelligent pulmonary function exercise device. The training prescription is two sessions per day, with each session consisting of 30 expiratory training repetitions and 30 inspiratory training repetitions, during hospitalization and at home until 30 days after surgery. The device records training completion and parameters, provides reminders and real-time feedback, and transmits data to the study center for adherence monitoring and remote management.	Device: Intelligent Pulmonary Function Exercise Device; Participants will receive usual perioperative care and active respiratory training using an intelligent pulmonary function exercise device. The training prescription is two sessions per day, with each session consisting of 30 expiratory training repetitions and 30 inspiratory training repetitions, during hospitalization and at home until 30 days after surgery. The device records training completion and parameters, provides reminders and real-time feedback, and transmits data to the study center for adherence monitoring and remote management.
Active Comparator: Usual Care and Natural Recovery Group; Participants will receive usual perioperative care, standard discharge education, safety instructions, and natural recovery follow-up. No study-specified respiratory training device, prescribed number of respiratory training sessions, or dynamic training targets will be provided. Any self-initiated respiratory training, use of respiratory training devices, or pulmonary rehabilitation outside the study will be recorded during follow-up.	Behavioral: Usual Care and Natural Recovery; Participants will receive usual perioperative care, standard discharge education, safety instructions, and natural recovery follow-up. No study-specified respiratory training device, prescribed number of respiratory training sessions, or dynamic training targets will be provided. Any self-initiated respiratory training, use of respiratory training devices, or pulmonary rehabilitation outside the study will be recorded during follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Forced Expiratory Volume in 1 Second From Baseline to 30 Days After Surgery	The primary outcome is the change in FEV1, measured in liters, from the preoperative baseline to 30 days after surgery. FEV1 will be measured using standardized pulmonary function testing. The between-group difference in the change in FEV1 will be compared.	Baseline and 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in FEV1 From Baseline to 90 Days After Surgery	Baseline and 90 days after surgery
Dyspnea-12 Score	Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery
MD Anderson Symptom Inventory-Lung Cancer Module Score	Baseline, 30 days after surgery, and 90 days after surgery
Six-Minute Walk Distance	Baseline, 30 days after surgery, and 90 days after surgery

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ES-2025-266-27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No