Effects of Different Physical Therapy Programs on Pulmonary Rehabilitation in Patients With Lung Cancer

Not Applicable

• Conditions: Rehabilitation
• Interventions: Device: acpella®PEP; Behavioral: ACBT training; Device: EDP-type II external diaphragm pacemaker

• Registration Number: NCT04914624
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This study applies external diaphragm pacemaker and positive expiratory pressure therapy to patients who received thoracic surgeries, in order to explore the effects of different physical therapy programs on pulmonary rehabilitation in patients with lung cancer. As well as we hope that these physical training programs can effectively improve the lung function of patients, reduce postoperative pulmonary complications, hospitalization days, hospitalization expenses, etc.

Detailed Description

This study applies external diaphragm pacemaker and positive expiratory pressure therapy to patients who received thoracic surgeries, ninety patients may be enrolled in this study.

Some metrics are used to evaluate the pulmonary rehabilitation status in postoperative patients which include pulmonary function test, 6-Min Walking Test，Borg index, complications incidence, chest tube draining time, and diaphragm muscle mobility.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-12-30
• Status Verified: 2021-05
• Study First Submitted QC: 2021-06-03
• Last Update Submitted: 2021-06-03
• Study First Posted: 2021-06-04
• Last Update Posted: 2021-06-04
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patients who are diagnosed with non-small cell lung cancer with clear pathological cytology by fiberoptic bronchoscopy and CT, and plan to undergo lobectomy or segmentectomy under general anesthesia for tracheal intubation;
2. Age 18-80 years old;
3. Those who have stable vital signs and can participate in this research;
4. Pulmonary function test FEV1/FVC>0.8.
5. Volunteer to participate in this research and sign an informed consent form.

Exclusion Criteria

1. Pneumonectomy patients;
2. Wedge resection patients
3. Patients with distant metastasis of cancer;
4. Patients with other malignant tumors;
5. Severe complications occurred during the operation, and respiratory function training and testing are not allowed before and after Evaluator;
6. Patients with severe physical or mental illness who cannot cooperate with the test;
7. Patients with pacemakers, active tuberculosis, and pneumothorax.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive expiratory pressure therapy	acpella®PEP	Use acpella®PEP therapeutic system and regular nursing care.
Regular ACBT training	ACBT training	Including quitting smoking, ACBT training, cough practicing.
External diaphragm pacemaker	EDP-type II external diaphragm pacemaker	Patients are trained to use external diaphragm pacemaker and receive regular nursing care.

Primary Outcome Measures

Name	Time	Method
The change from baseline Forced Expiratory Volume In One Second at one month after surgery	baseline (before the surgery), and one month after surgery	Evaluate the change of Forced Expiratory Volume In One Second before the surgery and one month after surgery by conducting Pulmonary Function Test on resectable NSCLC patients

Trial Locations

Locations (1)

Sun Yat sen University cancer center; 🇨🇳 Guangzhou, Guangdong, China