Study on the Prevention and Control System of Chronic Airway Diseases

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Study on the Prevention and Control System of Chronic Airway Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04348344
• Other study ID #: 2019-161-K110
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: May 2020
• Source: China-Japan Friendship Hospital
• Contact: Ting Yang, MD
• Phone: 13651380809
• Email: dryangting[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

References & Publications (5)

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

Outcome

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