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NCT Number: NCT07631520

Intelligent 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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Exclusion criteria

  • 1. 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.

Treatment and study plan

Intelligent Pulmonary Function Exercise Device

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.

Usual Care and Natural Recovery

Behavioral

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.

Primary outcomes

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

    Time frame: Baseline and 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.

Secondary outcomes

  1. Change in FEV1 From Baseline to 90 Days After Surgery

    Time frame: Baseline and 90 days after surgery

  2. Dyspnea-12 Score

    Time frame: Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery

  3. MD Anderson Symptom Inventory-Lung Cancer Module Score

    Time frame: Baseline, 30 days after surgery, and 90 days after surgery

  4. Six-Minute Walk Distance

    Time frame: Baseline, 30 days after surgery, and 90 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Jianxing He, MD

CONTACT

[email protected]

020-83062810

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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