COPD
Conditions
Interventions
experimental group:The subjects were treated with inspiratory plus expiratory neuromuscular electrical stimulation, once a day for 30 minutes, and totally for 4 weeks.
control group:The subjects were treated with inspiratory neuromuscular electrical stimulation once a day for 30 minutes, and totally for 4 weeks.
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) written informed consent; 2) Aged 40-75 years; 3) Chronic obstructive pulmonary disease (COPD); According to the history of smoking and other high-risk factors, clinical symptoms, signs and pulmonary function examination diagnosis. The necessary condition for COPD diagnosis is: FEV 1 / FVC < 0.70 after inhalation of bronchodilator during pulmonary function examination; 4) The severity of airflow restriction in COPD subjects met the following conditions: FEV 1 / FVC < 0.70 and FEV 1 < 50% of predicted value (i.e. gold Level 3–Gold level 4); 5) The subjects' modified dyspnea index (MMRC) was in accordance with: 1-3.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria shall not be included in this study: 1) Unable to complete the experiment; 2) Contraindications of respiratory neuromuscular stimulator or diaphragm pacemaker: a. Implanting pacemaker in vivo; b. Thoracic and abdominal surgery in one month; c. Pregnant women or lactating women; d. Electrode allergy on the body surface; 3) An acute exacerbation event four weeks prior screening period; 4) Suffer from other lung diseases, such as pneumothorax, tuberculosis, lung cancer; 5) Under the rest condition of breathing ambient air at sea level: PaO2 50mmHg; 6) Subjects who were using invasive or noninvasive mechanical ventilation; 7) According to the NYHA heart function classification, subjects with heart function level III-IV; 8) Unstable angina or myocardial infarction occurred within 30 days before screening; 9) Renal function: according to the CKD-EPI formula, the calculated creatinine clearance rate is = 1.5 times of the upper limit of normal value; 11) Other clinical trials were conducted within 30 days before the screening period; 12) Other conditions, mental disorders, cognitive disorders, etc. that cant cooperate with study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute walk distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| mMRC;pulmonary function;PaO2;PaCO2;Diaphragm motion during quiet breathing;Diaphragm motion during deep breathing; | — |
Countries
China
Contacts
Public ContactTong Zhaohui
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed