Single-Center Intelligent Pulmonary Rehabilitation After Lung Cancer Surgery
A 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intelligent Pulmonary Function Exercise Device Group
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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.
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Comparatore attivo: Usual Care and Natural Recovery Group
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change in Forced Expiratory Volume in 1 Second From Baseline to 30 Days After Surgery
Lasso di tempo: Baseline and 30 days after surgery
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Baseline and 30 days after surgery
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change in FEV1 From Baseline to 90 Days After Surgery
Lasso di tempo: Baseline and 90 days after surgery
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Baseline and 90 days after surgery
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Dyspnea-12 Score
Lasso di tempo: Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery
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Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery
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MD Anderson Symptom Inventory-Lung Cancer Module Score
Lasso di tempo: Baseline, 30 days after surgery, and 90 days after surgery
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Baseline, 30 days after surgery, and 90 days after surgery
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Six-Minute Walk Distance
Lasso di tempo: Baseline, 30 days after surgery, and 90 days after surgery
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Baseline, 30 days after surgery, and 90 days after surgery
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Postoperative Complications
Lasso di tempo: Up to 90 days after surgery
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Up to 90 days after surgery
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ES-2025-266-28
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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