Clinical trial NCT04348344: Study on the Prevention and Control System of Chronic Airway Diseases
Official title: Study on the Prevention and Control System of Chronic Airway Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
asthma
pulmonary rehabilitation
air pollutans
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 522
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: First of all, the investigators need to obtain detailed history records, including cardio pulmonary vascular history, related complications, treatment history and other high-risk factors. After careful review, the investigators need to determine whether the patient is suitable to participate in the pulmonary rehabilitation plan. The investigators need to pay special attention to diseases that may affect the patient's performance, including special cardiovascular diseases, skeletal muscle and nervous system.

Functional evaluation: pulmonary function test, exercise cardiopulmonary function evaluation (6-minute walking test), grip strength test, psychological state evaluation ( Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 9-item (phq-9)), nutrition screening and evaluation and others (general examination such as height, weight, BMI, waist and hip circumference, WHR, blood pressure, heart rate and blood biochemical examination; quality of life evaluation; other related individual evaluation Estimation includes smoking and sleep).

1. Acute exacerbation:

   The exercise prescription of "hospitalization + home rehabilitation" was adopted, which mainly combined aerobic endurance training, intermittent strength training and inspiratory muscle training, as follows:

   Aerobic exercise: 4 times / week, 30min / time, fast walking or power cycling Strength training: unarmed or instrument, 4 times / week, 3 groups / time, 10-12 times / group Breath training: ① breath Trainer: once a day, 20-30min a time

   ② Abdominal breathing training: 1-2 times / day, 10min / time
2. Stable patients:

Using the "home-based rehabilitation" exercise prescription, taking home exercise as the main form, using the sports bracelet and special respiratory rehabilitation app software, the home management system integrating home rehabilitation training, detection and feedback is mainly adopted, which is a combination of aerobic endurance training, intermittent strength training and inspiratory muscle training, as follows:

Aerobic exercise: 2-3 times / week, 30min / time, walk quickly Strength training: elastic band, 2-3 times / week, 3 groups / time, 10-12 times / group Breathing training: ① breathing exercise apparatus, 1-2 times / day, 10min / time

② Abdominal breathing training, 1-2 times / day, 10min / time

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Times of acute exacerbation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation
timeFrame: 9 months
measure: Change from Baseline Fractional exhaled Nitric Oxide (FeNO) at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline Eosinophil Count in Sputum at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline Inflammatory Factors in sputum at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline modified Medical Research Council dyspnea (mMRC) at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline COPD assessment test (CAT) at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline St George's questionnaire (SGRQ) at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline Patient Health Questionnaire 9-item (PHQ-9) at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline Generalized Anxiety Disorder 7-item (GAD-7) at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline Pittsburgh Sleep Quality Index (PSQI) at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline Pulmonary Function of FEV1 at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline Pulmonary Function of FVC at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline Pulmonary Function of FEV1/FVC at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Other outcomes:
measure: Change from Baseline Body Mass Index (BMI) at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline Weight in Kilograms at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Baseline Height in Meters at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Waist Circumference in Centimeters at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Hip Circumference in Centimeters at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
measure: Change from Waist-Hip Ratio (WHR) at 4, 8, 12 weeks, 6 months and 12 months
timeFrame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Locations:
Study officials:
affiliation: China-Japan Friendship Hospital
name: Ting Yang, MD
role: STUDY_CHAIR
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