Study on the Prevention and Control System of Chronic Airway Diseases

NCT04348344 | Unknown

• 1 other identifier: 2019-161-K110
• Study Type: interventional
• Target: 522
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; asthma; pulmonary rehabilitation; air pollutans

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

  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

  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

  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

  baseline and 4, 8, 12 weeks, 6 months and 12 months

Other Outcomes (6)

• Change from Baseline Body Mass Index (BMI) at 4, 8, 12 weeks, 6 months and 12 months

  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

  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

  baseline and 4, 8, 12 weeks, 6 months and 12 months

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

health education of pulmonary rehabilitation

Interventions

pulmonary rehabilitation BEHAVIORAL

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.

intervention group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Related Publications (5)

• 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.

  PMID: 29650248 RESULT

• 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.

  PMID: 28339144 RESULT

• 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.

  PMID: 24127811 RESULT

• 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.

  PMID: 30578215 RESULT

• 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.

  PMID: 11462077 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ting Yang, MD

  China-Japan Friendship Hospital

  STUDY CHAIR

Central Study Contacts

Ting Yang, MD

CONTACT

13651380809; dryangting@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 16, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share