Clinical trial NCT04914624: Effects of Different Physical Therapy Programs on Pulmonary Rehabilitation in Patients With Lung Cancer
Official title: Effects of Different Physical Therapy Programs on Pulmonary Rehabilitation in Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation
Keywords: pulmonary rehabilitation
external diaphragm pacemaker
expiratory pressure therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change from baseline Forced Expiratory Volume In One Second at one month after surgery
timeFrame: baseline (before the surgery), and one month after surgery
Secondary outcomes:
Other outcomes:
measure: The change from baseline Borg Score at one month after surgery.
timeFrame: baseline (before the surgery), and one month after surgery
measure: Complications incidence
timeFrame: One month after surgery
Locations:
city: Guangzhou
country: China
facility: Sun Yat sen University cancer center
state: Guangdong
Study officials:
References: