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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: pulmonary rehabilitation

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

• Study Type: Interventional
• Enrollment (Anticipated): 522
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Yang, MD; Phone Number: 13651380809; Email: dryangting@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: intervention group; 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; 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.
NO_INTERVENTION: control group; health education of pulmonary rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Times of acute exacerbation	times of acute exacerbation in the period of one year	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Study Chair: Ting Yang, MD, China-Japan Friendship Hospital

Publications and helpful links

General Publications

• 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, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
• 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, Osadnik C, Roberts M, Walsh J, Wootton S, Holland AE; Lung Foundation Australia and the Thoracic Society of Australia and New Zealand. Australian and New Zealand Pulmonary Rehabilitation Guidelines. Respirology. 2017 May;22(4):800-819. doi: 10.1111/resp.13025. Epub 2017 Mar 24.
• 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 der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum In: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.
• 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, Busching G, Strassmann A, Serra I, Vogiatzis I, Garcia-Aymerich J, Polkey MI, Troosters T. Smartphone-Based Physical Activity Telecoaching in Chronic Obstructive Pulmonary Disease: Mixed-Methods Study on Patient Experiences and Lessons for Implementation. JMIR Mhealth Uhealth. 2018 Dec 21;6(12):e200. doi: 10.2196/mhealth.9774.
• Storer TW. Exercise in chronic pulmonary disease: resistance exercise prescription. Med Sci Sports Exerc. 2001 Jul;33(7 Suppl):S680-92. doi: 10.1097/00005768-200107001-00006.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: asthma; pulmonary rehabilitation; Chronic Obstructive Pulmonary Disease; air pollutans
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2019-161-K110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No