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临床试验/NCT04914624
NCT04914624Unknown不适用

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

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
The change from baseline Forced Expiratory Volume In One Second at one month after surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.
  • •Volunteer to participate in this research and sign an informed consent form.

排除标准

  • •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.

研究组 & 干预措施

Regular ACBT training

Placebo Comparator

Including quitting smoking, ACBT training, cough practicing.

干预措施: ACBT training (Behavioral)

Positive expiratory pressure therapy

Experimental

Use acpella®PEP therapeutic system and regular nursing care.

干预措施: acpella®PEP (Device)

External diaphragm pacemaker

Experimental

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

干预措施: EDP-type II external diaphragm pacemaker (Device)

结局指标

主要结局

The change from baseline Forced Expiratory Volume In One Second at one month after surgery

时间窗: baseline (before the surgery), and 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

次要结局

未报告次要终点

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Long

Professor

Sun Yat-sen University

研究点 (1)

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