Non-Small Cell Lung CancerNCT07631520
Intelligent Pulmonary Rehabilitation After Lung Cancer Surgery
A study testing Intelligent Pulmonary Function Exercise Device in people with Non-Small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Intelligent Pulmonary Function Exercise Device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read more
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
- Being tested
- Intelligent Pulmonary Function Exercise Device, Usual Care and Natural Recovery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Pulmonary Function Exercise DeviceDevice
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 RecoveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Intelligent Pulmonary Function Exercise Device |
| Usual Care and Natural Recovery Group | Active comparator | 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. Receives: Behavioral: Usual Care and Natural Recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 30 days after surgery
Secondary outcomes (4)
Change in FEV1 From Baseline to 90 Days After Surgery
Measured: Baseline and 90 days after surgery
Dyspnea-12 Score
Measured: Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery
MD Anderson Symptom Inventory-Lung Cancer Module Score
Measured: Baseline, 30 days after surgery, and 90 days after surgery
Six-Minute Walk Distance
Measured: Baseline, 30 days after surgery, and 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either intelligent pulmonary function exercise device-guided pulmonary rehabilitation or usual care with natural recovery after lung cancer surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631520
- Sponsor's protocol ID
- ES-2025-266-27
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07631520
- Acronym / sponsor ID
- ES-2025-266-27
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either intelligent pulmonary function exercise device-guided pulmonary rehabilitation or usual care with natural recovery after lung cancer surgery.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Intelligent Pulmonary Function Exercise DeviceParticipants 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 Group | Active comparator | Behavioral: Usual Care and Natural RecoveryParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent Pulmonary Function Exercise DeviceParticipants 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 | Experimental |
| Usual Care and Natural RecoveryParticipants 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. | Behavioural | Usual Care and Natural Recovery Group |
Primary outcome
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.
4 secondary outcomes
Change in FEV1 From Baseline to 90 Days After Surgery
Time frame: Baseline and 90 days after surgery
Dyspnea-12 Score
Time frame: Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery
MD Anderson Symptom Inventory-Lung Cancer Module Score
Time frame: Baseline, 30 days after surgery, and 90 days after surgery
Six-Minute Walk Distance
Time frame: Baseline, 30 days after surgery, and 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Pulmonary Function Exercise Device in people with Non-Small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianxing He, MD (020-83062810, jianxinghe@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Expiratory Volume in 1 Second From Baseline to 30 Days After Surgery (time frame: Baseline and 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.