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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Jianxing He, MD
- Telefonnummer: 020-83062810
- E-Mail: jianxinghe@gzhmu.edu.cn
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
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.
|
|
Aktiver Komparator: 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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second From Baseline to 30 Days After Surgery
Zeitfenster: 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.
|
Baseline and 30 days after surgery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in FEV1 From Baseline to 90 Days After Surgery
Zeitfenster: Baseline and 90 days after surgery
|
Baseline and 90 days after surgery
|
|
Dyspnea-12 Score
Zeitfenster: Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery
|
Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery
|
|
MD Anderson Symptom Inventory-Lung Cancer Module Score
Zeitfenster: Baseline, 30 days after surgery, and 90 days after surgery
|
Baseline, 30 days after surgery, and 90 days after surgery
|
|
Six-Minute Walk Distance
Zeitfenster: Baseline, 30 days after surgery, and 90 days after surgery
|
Baseline, 30 days after surgery, and 90 days after surgery
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ES-2025-266-27
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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