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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04914624
Enrollment
90
Registered
2021-06-04
Start date
2020-05-01
Completion date
2021-12-30
Last updated
2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation

Keywords

pulmonary rehabilitation, external diaphragm pacemaker, expiratory pressure therapy

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.

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.

Interventions

BEHAVIORALACBT training

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

DEVICEacpella®PEP

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

DEVICEEDP-type II external diaphragm pacemaker

Use external diaphragm pacemaker to stimulate patients' diaphragms.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The change from baseline Forced Expiratory Volume In One Second at one month after surgerybaseline (before the surgery), and one month after surgeryEvaluate 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

Other

MeasureTime frameDescription
The change from baseline Borg Score at one month after surgery.baseline (before the surgery), and one month after surgeryBorg 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
Complications incidenceOne month after surgeryRecord the complications of patients after surgery.

Countries

China

Contacts

Primary ContactJiudi Zhong, Bachelor
zhongjd@sysucc.org.cn+86 87343317
Backup ContactHao Long, MD
longhao@sysucc.org.cn+86 87343261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026