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

NCT04914624 | Unknown DMC

• 1 other identifier: 2020-ZJD-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation

Keywords

pulmonary rehabilitation; external diaphragm pacemaker; expiratory pressure therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The change from baseline Borg Score at one month after surgery.

  baseline (before the surgery), and one month after surgery

• Complications incidence

  One month after surgery

Study Arms (3)

Regular ACBT training

PLACEBO COMPARATOR

Including quitting smoking, ACBT training, cough practicing.

Behavioral: ACBT training

Positive expiratory pressure therapy

EXPERIMENTAL

Use acpella®PEP therapeutic system and regular nursing care.

Device: acpella®PEP

External diaphragm pacemaker

EXPERIMENTAL

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

Device: EDP-type II external diaphragm pacemaker

Interventions

ACBT training BEHAVIORAL

Performed 5 days before surgery and one month after surgery, twice a day.

Regular ACBT training

acpella®PEP DEVICE

Continuously instruct patients to perform positive expiratory pressure training 5 days before surgery and one month after surgery, twice a day.

Positive expiratory pressure therapy

EDP-type II external diaphragm pacemaker DEVICE

Use external diaphragm pacemaker to stimulate patients' diaphragms.

External diaphragm pacemaker

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat sen University cancer center

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

• Chen X, Li C, Zeng L, Rong T, Lin P, Wang Q, Guo Z, Long H, Zhong J. Comparative efficacy of different combinations of acapella, active cycle of breathing technique, and external diaphragmatic pacing in perioperative patients with lung cancer: a randomised controlled trial. BMC Cancer. 2023 Mar 28;23(1):282. doi: 10.1186/s12885-023-10750-4.

  PMID: 36978035 DERIVED

Central Study Contacts

Jiudi Zhong, Bachelor

CONTACT

+86 87343317; zhongjd@sysucc.org.cn

Hao Long, MD

CONTACT

+86 87343261; longhao@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: June 4, 2021
• Study Start: May 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-05

Locations

CN (1)