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Study on the Prevention and Control System of Chronic Airway Diseases

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulmonary rehabilitation
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, asthma, pulmonary rehabilitation, air pollutans

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    control group

    Arm Description

    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.

    health education of pulmonary rehabilitation

    Outcomes

    Primary Outcome Measures

    Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months
    walking distance in 6-minute walking test
    Times of acute exacerbation
    times of acute exacerbation in the period of one year

    Secondary Outcome Measures

    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
    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)
    Change from Baseline Eosinophil Count in Sputum at 4, 8, 12 weeks, 6 months and 12 months
    Eosinophil Count
    Change from Baseline Inflammatory Factors in sputum at 4, 8, 12 weeks, 6 months and 12 months
    inflammatory factors in sputum
    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.
    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.
    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.
    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.
    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.
    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.
    Change from Baseline Pulmonary Function of FEV1 at 4, 8, 12 weeks, 6 months and 12 months
    FEV1
    Change from Baseline Pulmonary Function of FVC at 4, 8, 12 weeks, 6 months and 12 months
    FVC
    Change from Baseline Pulmonary Function of FEV1/FVC at 4, 8, 12 weeks, 6 months and 12 months
    FEV1/FVC

    Full Information

    First Posted
    April 7, 2020
    Last Updated
    May 12, 2020
    Sponsor
    China-Japan Friendship Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04348344
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    September 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China-Japan Friendship Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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). 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 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    Chronic Obstructive Pulmonary Disease, asthma, pulmonary rehabilitation, air pollutans

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    522 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    health education of pulmonary rehabilitation
    Intervention Type
    Behavioral
    Intervention Name(s)
    pulmonary rehabilitation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months
    Description
    walking distance in 6-minute walking test
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Title
    Times of acute exacerbation
    Description
    times of acute exacerbation in the period of one year
    Time Frame
    through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation
    Description
    Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation
    Time Frame
    9 months
    Title
    Change from Baseline Fractional exhaled Nitric Oxide (FeNO) at 4, 8, 12 weeks, 6 months and 12 months
    Description
    changes of Fractional exhaled Nitric Oxide (FeNO)
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Title
    Change from Baseline Eosinophil Count in Sputum at 4, 8, 12 weeks, 6 months and 12 months
    Description
    Eosinophil Count
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Title
    Change from Baseline Inflammatory Factors in sputum at 4, 8, 12 weeks, 6 months and 12 months
    Description
    inflammatory factors in sputum
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Title
    Change from Baseline modified Medical Research Council dyspnea (mMRC) at 4, 8, 12 weeks, 6 months and 12 months
    Description
    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
    Title
    Change from Baseline COPD assessment test (CAT) at 4, 8, 12 weeks, 6 months and 12 months
    Description
    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
    Title
    Change from Baseline St George's questionnaire (SGRQ) at 4, 8, 12 weeks, 6 months and 12 months
    Description
    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
    Title
    Change from Baseline Patient Health Questionnaire 9-item (PHQ-9) at 4, 8, 12 weeks, 6 months and 12 months
    Description
    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
    Title
    Change from Baseline Generalized Anxiety Disorder 7-item (GAD-7) at 4, 8, 12 weeks, 6 months and 12 months
    Description
    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
    Title
    Change from Baseline Pittsburgh Sleep Quality Index (PSQI) at 4, 8, 12 weeks, 6 months and 12 months
    Description
    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
    Title
    Change from Baseline Pulmonary Function of FEV1 at 4, 8, 12 weeks, 6 months and 12 months
    Description
    FEV1
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Title
    Change from Baseline Pulmonary Function of FVC at 4, 8, 12 weeks, 6 months and 12 months
    Description
    FVC
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Title
    Change from Baseline Pulmonary Function of FEV1/FVC at 4, 8, 12 weeks, 6 months and 12 months
    Description
    FEV1/FVC
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Other Pre-specified Outcome Measures:
    Title
    Change from Baseline Body Mass Index (BMI) at 4, 8, 12 weeks, 6 months and 12 months
    Description
    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
    Title
    Change from Baseline Weight in Kilograms at 4, 8, 12 weeks, 6 months and 12 months
    Description
    weight in kilograms
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Title
    Change from Baseline Height in Meters at 4, 8, 12 weeks, 6 months and 12 months
    Description
    height in meters
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Title
    Change from Waist Circumference in Centimeters at 4, 8, 12 weeks, 6 months and 12 months
    Description
    waist circumference in centimeters
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Title
    Change from Hip Circumference in Centimeters at 4, 8, 12 weeks, 6 months and 12 months
    Description
    hip circumference in centimeters
    Time Frame
    baseline and 4, 8, 12 weeks, 6 months and 12 months
    Title
    Change from Waist-Hip Ratio (WHR) at 4, 8, 12 weeks, 6 months and 12 months
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ting Yang, MD
    Phone
    13651380809
    Email
    dryangting@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ting Yang, MD
    Organizational Affiliation
    China-Japan Friendship Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29650248
    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, 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.
    Results Reference
    result
    PubMed Identifier
    28339144
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    24127811
    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 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.
    Results Reference
    result
    PubMed Identifier
    30578215
    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, 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.
    Results Reference
    result
    PubMed Identifier
    11462077
    Citation
    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.
    Results Reference
    result

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