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

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.

Study Overview

• Status: Recruiting
• Conditions: Rehabilitation
• Intervention / Treatment: Behavioral: ACBT training; Device: acpella®PEP; Device: EDP-type II external diaphragm pacemaker

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiudi Zhong, Bachelor; Phone Number: +86 87343317; Email: zhongjd@sysucc.org.cn
• Study Contact Backup: Name: Hao Long, MD; Phone Number: +86 87343261; Email: longhao@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat Sen University Cancer Center
      • Contact: Jiudi Zhong, Bachelor; Phone Number: +86 13610181300; Email: zhongjd@sysucc.org.cn
      • Contact: Qinglin Wang, Bachelor; Phone Number: +86 13826293429; Email: wangql@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complications incidence	Record the complications of patients after surgery.	One month after surgery

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; external diaphragm pacemaker; expiratory pressure therapy
• Other Study ID Numbers: 2020-ZJD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No