Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Study on the Prevention and Control System of Chronic Airway Diseases
In this study, patients with Chronic Obstructive Pulmonary Diseases (COPD) in stable and acute exacerbation stage were selected as the research objects, and the open, parallel and randomized controlled clinical trial design was adopted. Participants were randomly divided into trial group and control group. The control group was only given routine education, and the experimental group, on the basis of routine education, developed a respiratory rehabilitation training program lasting for 12 weeks according to the individual situation of patients. All participants were interviewed for 6 times (baseline and 4,8,12 weeks, 6 months and 12 months after admission) for a period of 1 year. Acute exacerbation, activity tolerance (6-minute walking test), living environment, clinical symptoms, lung function, airway inflammation water level index and biological samples were collected at each visit. At the same time, according to the diary filled in by the patients, the investigators can obtain the daily stay time indoors and outdoors and the longitude and latitude information of the regular stay fixed place, and geographic information system (GIS) is used to match the nearest environmental monitoring station, obtain the data of air pollutants and meteorological indicators (SO2, NO2, Co, O3, PM10, temperature and humidity, etc.), and estimate the individual exposure level of air pollutants.
Status | Not yet recruiting |
Enrollment | 522 |
Est. completion date | September 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - It meets the diagnostic criteria of global initiative for chronic obstructive pulmonary disease (gold 2017 Edition), is in a stable period of disease or meets the diagnostic criteria of guidelines for the prevention and treatment of bronchial asthma (GINA 2016 Edition) - Have lived in the local area for more than 2 consecutive years, and there is no plan to go out for more than half a year in succession during the survey period - No smoking history or no smoking for half a year or more - 40-75 years old Exclusion Criteria: - Patients with history of chronic diseases, such as serious cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, epilepsy and other nervous system diseases, mental diseases, psychiatric diseases, active pulmonary tuberculosis, tumor, anti tuberculosis treatment or combined influence information collection - Patients who have undergone thoracic, abdominal and ophthalmic operations in the past 3 months - Pregnant and lactating women - Did not sign informed consent |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
China-Japan Friendship Hospital |
Alison JA, McKeough ZJ, Johnston K, McNamara RJ, Spencer LM, Jenkins SC, Hill CJ, McDonald VM, Frith P, Cafarella P, Brooke M, Cameron-Tucker HL, Candy S, Cecins N, Chan AS, Dale MT, Dowman LM, Granger C, Halloran S, Jung P, Lee AL, Leung R, Matulick T, O — View Citation
Loeckx M, Rabinovich RA, Demeyer H, Louvaris Z, Tanner R, Rubio N, Frei A, De Jong C, Gimeno-Santos E, Rodrigues FM, Buttery SC, Hopkinson NS, Büsching G, Strassmann A, Serra I, Vogiatzis I, Garcia-Aymerich J, Polkey MI, Troosters T. Smartphone-Based Phys — View Citation
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van — View Citation
Storer TW. Exercise in chronic pulmonary disease: resistance exercise prescription. Med Sci Sports Exerc. 2001 Jul;33(7 Suppl):S680-92. Review. — View Citation
Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from Baseline Body Mass Index (BMI) at 4, 8, 12 weeks, 6 months and 12 months | weight and height will be combined to report BMI in kg/m^2 | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Other | Change from Baseline Weight in Kilograms at 4, 8, 12 weeks, 6 months and 12 months | weight in kilograms | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Other | Change from Baseline Height in Meters at 4, 8, 12 weeks, 6 months and 12 months | height in meters | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Other | Change from Waist Circumference in Centimeters at 4, 8, 12 weeks, 6 months and 12 months | waist circumference in centimeters | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Other | Change from Hip Circumference in Centimeters at 4, 8, 12 weeks, 6 months and 12 months | hip circumference in centimeters | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Other | Change from Waist-Hip Ratio (WHR) at 4, 8, 12 weeks, 6 months and 12 months | hip and waist circumference in centimeters will be combined to report WHR | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Primary | Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months | walking distance in 6-minute walking test | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Primary | Times of acute exacerbation | times of acute exacerbation in the period of one year | through study completion, an average of 1 year | |
Secondary | Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation | Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation | 9 months | |
Secondary | Change from Baseline Fractional exhaled Nitric Oxide (FeNO) at 4, 8, 12 weeks, 6 months and 12 months | changes of Fractional exhaled Nitric Oxide (FeNO) | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline Eosinophil Count in Sputum at 4, 8, 12 weeks, 6 months and 12 months | Eosinophil Count | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline Inflammatory Factors in sputum at 4, 8, 12 weeks, 6 months and 12 months | inflammatory factors in sputum | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline modified Medical Research Council dyspnea (mMRC) at 4, 8, 12 weeks, 6 months and 12 months | the minimum values is 0 and maximum values is 4, the higher scores mean a worse outcome. | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline COPD assessment test (CAT) at 4, 8, 12 weeks, 6 months and 12 months | the minimum values is 0 and maximum values is 40, the higher scores mean a worse outcome. | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline St George's questionnaire (SGRQ) at 4, 8, 12 weeks, 6 months and 12 months | the minimum values is 0 and maximum values is 100, the higher scores mean a worse outcome. | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline Patient Health Questionnaire 9-item (PHQ-9) at 4, 8, 12 weeks, 6 months and 12 months | the minimum values is 0 and maximum values is 27, the higher scores mean a worse outcome. | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline Generalized Anxiety Disorder 7-item (GAD-7) at 4, 8, 12 weeks, 6 months and 12 months | the minimum values is 0 and maximum values is 21, the higher scores mean a worse outcome. | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline Pittsburgh Sleep Quality Index (PSQI) at 4, 8, 12 weeks, 6 months and 12 months | the minimum values is 0 and maximum values is 21, the higher scores mean a worse outcome. | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline Pulmonary Function of FEV1 at 4, 8, 12 weeks, 6 months and 12 months | FEV1 | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline Pulmonary Function of FVC at 4, 8, 12 weeks, 6 months and 12 months | FVC | baseline and 4, 8, 12 weeks, 6 months and 12 months | |
Secondary | Change from Baseline Pulmonary Function of FEV1/FVC at 4, 8, 12 weeks, 6 months and 12 months | FEV1/FVC | baseline and 4, 8, 12 weeks, 6 months and 12 months |
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