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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914624
• Other study ID #: 2020-ZJD-001
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2021
• Source: Sun Yat-sen University
• Contact: Jiudi Zhong, Bachelor
• Phone: +86 87343317
• Email: zhongjd[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rehabilitation

Intervention

Behavioral:
• ACBT training
Performed 5 days before surgery and one month after surgery, twice a day.

Device:
• acpella®PEP
Continuously instruct patients to perform positive expiratory pressure training 5 days before surgery and one month after surgery, twice a day.
• EDP-type II external diaphragm pacemaker
Use external diaphragm pacemaker to stimulate patients' diaphragms.

Locations

Country	Name	City	State
China	Sun Yat sen University cancer center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change from baseline Borg Score at one month after surgery.	Borg Score is a rating of perceived exertion which is a reliable indicator to monitor and guide exercise intensity.It allows individuals to subjectively rate their level of exertion during exercise testing.We would record patients' Borg Score after 6 minutes walking test	baseline (before the surgery), and one month after surgery
Other	Complications incidence	Record the complications of patients after surgery.	One month after surgery
Primary	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