An interventional study of pulmonary rehabilitation in Chronic Obstructive Pulmonary Disease, sponsored by China-Japan Friendship Hospital. Status unknown. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-13.
Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment
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.
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).
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
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
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 522 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
health education of pulmonary rehabilitation pulmonary rehabilitation including aerobic exercise，strength training and breath training. Patients in stable stages using the "home-based rehabilitation" exercise prescription, taking home exercise, 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.
Behavioral: pulmonary rehabilitation
health education of pulmonary rehabilitation
Patients receive health education of pulmonary rehabilitation, 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: walking, intermittent strength training: elastic band and inspiratory muscle training:apparatus, abdominal breathing training.
Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months
walking distance in 6-minute walking test
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Times of acute exacerbation
times of acute exacerbation in the period of one year
Time frame: through study completion, an average of 1 year
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
Time frame: 9 months
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)
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Eosinophil Count in Sputum at 4, 8, 12 weeks, 6 months and 12 months
Eosinophil Count
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Inflammatory Factors in sputum at 4, 8, 12 weeks, 6 months and 12 months
inflammatory factors in sputum
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
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.
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
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.
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
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.
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
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.
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
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.
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
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.
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pulmonary Function of FEV1 at 4, 8, 12 weeks, 6 months and 12 months
FEV1
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pulmonary Function of FVC at 4, 8, 12 weeks, 6 months and 12 months
FVC
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pulmonary Function of FEV1/FVC at 4, 8, 12 weeks, 6 months and 12 months
FEV1/FVC
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
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
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Weight in Kilograms at 4, 8, 12 weeks, 6 months and 12 months
weight in kilograms
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Height in Meters at 4, 8, 12 weeks, 6 months and 12 months
height in meters
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Waist Circumference in Centimeters at 4, 8, 12 weeks, 6 months and 12 months
waist circumference in centimeters
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Hip Circumference in Centimeters at 4, 8, 12 weeks, 6 months and 12 months
hip circumference in centimeters
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
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
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
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Plan to share: No
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China-Japan Friendship Hospital