Chronic obstructive pulmonary disease
Conditions
Interventions
Test Group:Respiratory neuromuscular electrical stimulation therapy
Control Group:None
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Carefully read and signed the informed consent; 2. Aged 40-75 years (Note: including 40 years old and 75 years old), gender is not limited; 3. Have chronic obstructive pulmonary disease (COPD): Diagnosis is based on the history of high-risk factors such as smoking, clinical symptoms, signs and pulmonary function tests. A prerequisite for the diagnosis of COPD is: FEV1/FVC < 0.70* after inhalation of bronchodilator during pulmonary function test; 4. The severity of airflow limitation in subjects with chronic obstructive pulmonary disease (COPD) meets the following conditions: FEV1/FVC < 0.70 after subject inhalation of bronchodilator, and FEV1 < 80% predicted value (ie, GOLD level 2- GOLD level 4)*; 5. Subject's Modified Dyspnea Index (mMRC) meets: Grade 1 - Grade 3**. Note: * Based on the 2021 edition of the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD 2021) and the 8th edition of Internal Medicine. ** Shortness of breath when walking briskly on level ground or walking up a small slope (mMRC level 1); Walking slower than peers on level ground or needing to stop and rest due to shortness of breath (mMRC level 2); Need to stop and gasp after walking 100 meters or a few minutes on level ground (mMRC level 3).
Exclusion criteria
Exclusion criteria: 1. Have a significant disease or condition other than chronic obstructive pulmonary disease (COPD), and the investigator judges that any of the following may occur: (1) Subjects are at risk by participating in this experiment; (2) Affect the experimental results; (3) The subject cannot complete the experiment; 2. Subjects with contraindications to respiratory neuromuscular stimulator: (1) Bleeding tendency; (2) Coagulation dysfunction; (3) Spastic paralysis; (4) The following symptoms are present in the lower third of the sternocleidomastoid muscle, the pectoralis major muscle, and the abdomen: 1) Local acute purulent inflammation; 2) The damaged part of the skin; 3) Local malignant tumor; 4) Partial cardiac pacemaker; 5) Partial metal built-in; (5) Heart area; (6) Carotid sinus site; (7) Severe heart, liver and kidney failure, the test criteria are as follows: 1) Subjects with cardiac function class III-IV according to the New York Heart Association (NYHA) cardiac function classification; 2) Unstable angina or myocardial infarction within 30 days prior to the screening period; 3) Renal function: According to the Chronic Kidney Disease Epidemiology Institute (CKD-EPI) formula, the calculated value of creatinine clearance is = 1.5 times the upper limit of normal; (8) Spastic period after cerebrovascular accident; (9) Patients with severe cognitive impairment; (10) Unconsciousness, contracture deformity of limb bones and joints; (11) Abnormal neurological irritability; (12) Pregnant women (positive pregnancy test) and lactating women; (13) Local wounds that have not healed after thoracic and abdominal surgery; (14) Allergy to surface electrodes; 3. History of acute exacerbation of chronic obstructive pulmonary disease (COPD) within 30 days before the screening period; 4. Suffering from other active lung diseases, such as active pulmonary tuberculosis, etc.; 5. Subjects who intend to use the combined treatment of respiratory stimulant drugs (such as dimethylfrine hydrochloride, nicotine hydrochloride, doxapram hydrochloride, lobeline hydrochloride, etc.); 6. Subjects who are using invasive or non-invasive mechanical ventilation; 7. Participated in other interventional clinical trials within 30 days before the screening period; 8. Failure to follow experimental procedures or to cooperate with researchers; 9. Other conditions (such as: mental illness, cognitive impairment, etc.) judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six-minute walk distance (6MWD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified dyspnea severity Scale;Pulmonary function;maximal inspiratory pressure (MIP);maximal expiratory pressure(MEP);diaphragmatic excursion;Chronic Obstructive Pulmonary Disease Assessment Test (CAT);Activities of Daily Living (ADL);Activities of Daily Living (ADL);hospital anxiety and depression scale (HADS);assessment of body composition; | — |
Countries
China
Contacts
Public ContactTing Yang
China-Japan Friendship Hospital
Outcome results
None listed