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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rehabilitation

Intervention / Treatment
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* Behavioral: ACBT training
* Device: acpella®PEP
* Device: EDP-type II external diaphragm pacemaker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Age 18-80 years old; Those who have stable vital signs and can participate in this research; Pulmonary function test FEV1/FVC>0.8. Volunteer to participate in this research and sign an informed consent form. Exclusion Criteria: Pneumonectomy patients; Wedge resection patients Patients with distant metastasis of cancer; Patients with other malignant tumors; Severe complications occurred during the operation, and respiratory function training and testing are not allowed before and after Evaluator; Patients with severe physical or mental illness who cannot cooperate with the test; Patients with pacemakers, active tuberculosis, and pneumothorax.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Regular ACBT training<br>Including quitting smoking, ACBT training, cough practicing. | Behavioral: ACBT training<br>* Performed 5 days before surgery and one month after surgery, twice a day.<br>|
| Experimental: Positive expiratory pressure therapy<br>Use acpella®PEP therapeutic system and regular nursing care. | Device: acpella®PEP<br>* Continuously instruct patients to perform positive expiratory pressure training 5 days before surgery and one month after surgery, twice a day.<br>|
| Experimental: External diaphragm pacemaker<br>Patients are trained to use external diaphragm pacemaker and receive regular nursing care. | Device: EDP-type II external diaphragm pacemaker<br>* Use external diaphragm pacemaker to stimulate patients' diaphragms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline Forced Expiratory Volume In One Second at 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 | baseline (before the surgery), and one month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary rehabilitation, external diaphragm pacemaker, expiratory pressure therapy