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

Sun Yat-sen University

Status: Unknown

Conditions: Rehabilitation

Treatments: Device: EDP-type II external diaphragm pacemaker; Behavioral: ACBT training; Device: acpella®PEP

Study type: Interventional

Funder types: Other

Identifiers

NCT04914624

2020-ZJD-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Regular ACBT training

Placebo Comparator group

Description:

Including quitting smoking, ACBT training, cough practicing.

Treatment:

Behavioral: ACBT training

Positive expiratory pressure therapy

Experimental group

Description:

Use acpella®PEP therapeutic system and regular nursing care.

Treatment:

Device: acpella®PEP

External diaphragm pacemaker

Experimental group

Description:

Patients are trained to use external diaphragm pacemaker and receive regular nursing care.

Treatment:

Device: EDP-type II external diaphragm pacemaker