chronic obstructive pulmonary disease
Conditions
Interventions
Pulmonary rehabilitation exercise group:Conventional treatment, Respiratory rehabilitation training device Respiratory Muscle Training, Internet of things device monitoring (smart watch, some subjects
follow-up control group:Usual care, Internet of things devices monitoring(smartwatches, some subjects)
Sponsors
Xiamen Haicang Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 82 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria during the screening period: (1) patients aged 40-80 $who met the diagnosis of COPD; (2) resident of Xiamen City; (3) The report of pulmonary function test in the stable period of nearly 6 months showed that after the patient inhaled bronchodilator (15-30 minutes after inhaling 400µg of salbutamol), Forced Expiratory Volume in one second to Forced Vital Capacity ratio (FEV1/FVC) =35 years or =10 days) or 70% of the days during the screening period (14 days).
Exclusion criteria
Exclusion criteria: Exclusion criteria during the screening period: (1) complicated with important diseases other than COPD; A significant disease was defined as one that the investigator considered to be associated with a disease or severity of the disease that might put the patient at risk for participating in the study, or might affect the study results, or significantly affect the patient's ability to participate in the study. He suffered from myocardial infarction, stroke, and shock in the past 3 months. (2) Patients with clinically significant abnormalities in laboratory tests (such as blood routine, blood biochemistry, and urine routine) were defined as important diseases in the exclusion criteria (1). (3) complicated with clinically significant pneumoconiosis and other restrictive ventilation dysfunction diseases; (4) combined with uncured or advanced malignant tumors; (5) combined with asthma; (6) complicated with active pulmonary tuberculosis; (7) patients with life-threatening pulmonary embolism, clinically significant a1-antitrypsin deficiency or cystic fibrosis; (8) history of lobectomy; (9) inability to complete the 6-minute walk test alone; (10) meet the absolute contraindication of pulmonary function test; (11) participated in other respiratory clinical trials within 3 months before screening; (12) Patients with uncontrolled hypertension (systolic blood pressure >180mmHg, diastolic blood pressure >110mmHg) or uncontrolled hyperglycemia considered by the investigator to be unsuitable for clinical study. Exclusion criteria during the follow-up period During the screening period or after enrollment, participants who met any of the following criteria were not eligible for the follow-up period * : (1) concurrent acute diseases requiring intervention and affecting the study; (2) The required inspection items were not completed according to the requirements, which resulted in the inability to evaluate the main indicators; (3) Serious adverse events requiring withdrawal from the trial according to the investigator's judgment during the follow-up period; (4) Pregnancy during follow-up; (5) withdrawal, loss of follow-up or death during follow-up; (6) if the subjects did not meet any of the inclusion criteria or met any of the exclusion criteria. Subjects who met any of the above exclusion criteria were excluded from inclusion in the follow-up period. * If a subject is known or found to have intolerable allergic contact dermatitis with the body and/or band of the smartwatch, exit the smartwatch subgroup and recycle the smartwatch.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of moderate to severe AECOPD (times/person/year);Maximal inspiratory pressure Change from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time to first moderate or severe acute exacerbation of COPD;Frequency of acute exacerbations of COPD of any severity (number/person/year);Change from baseline in Six-Minute-Walk-Distance (6MWD);The change of COPD Assessment Test (CAT) score from baseline;The change of dyspnea scale (modified British Medical Research Council, mMRC) score from baseline;Sensitivity and specificity of early warning surveillance for acute exacerbation based on Internet of things devices; | — |
Countries
china
Contacts
Public ContactLingling Chen,Nanshan Zhong ,Jingpin Zheng,Yan Jiang
Xiamen Haicang Hospital
Outcome results
None listed