Single-Center Intelligent Pulmonary Rehabilitation After Lung Cancer Surgery

NCT07631533 | Not Yet Recruiting

• 1 other identifier: ES-2025-266-28
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Forced Expiratory Volume in 1 Second From Baseline to 30 Days After Surgery

  Baseline and 30 days after surgery

Secondary Outcomes (5)

• 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

• Postoperative Complications

  Up to 90 days after surgery

Study Arms (2)

Intelligent Pulmonary Function Exercise Device Group

EXPERIMENTAL

Device: Intelligent Pulmonary Function Exercise Device

Usual Care and Natural Recovery Group

ACTIVE COMPARATOR

Behavioral: Usual Care and Natural Recovery

Interventions

Usual Care and Natural Recovery BEHAVIORAL

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.

Usual Care and Natural Recovery Group

Intelligent Pulmonary Function Exercise Device 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.

Intelligent Pulmonary Function Exercise Device Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Able to communicate and complete study assessments and postoperative follow-up.
• \. Able to use a smartphone independently or with assistance from a caregiver for training records.
• \. 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.

You may not qualify if:

• \. Preoperative measured FEV1 less than 50% of predicted value. 2. Severe cardiopulmonary dysfunction or other conditions judged unsuitable for respiratory training.
• \. Previous thoracic surgery or major thoracic trauma. 4. Significant cognitive impairment or psychiatric disorder that prevents cooperation with the study.
• \. Pregnancy or breastfeeding. 6. Recent severe infection or active pulmonary disease.

Sponsors & Collaborators

• Jianxing He: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-05