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Effects of Pursed Lip Breathing on Muscle Oxygenation During walking with a portable oxygen concentrator in Interstitial Lung Disease : A randomized crossover trial

Status Approved

  • First Submitted Date

    2020/09/08

  • Registered Date

    2020/09/25

  • Last Updated Date

    2023/03/08

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005440
    Unique Protocol ID 202002120001
    Public/Brief Title Effects of Pursed Lip Breathing on Muscle Oxygenation During walking with a portable oxygen concentrator in Interstitial Lung Disease
    Scientific Title Effects of Pursed Lip Breathing on Muscle Oxygenation During walking with a portable oxygen concentrator in Interstitial Lung Disease : A randomized crossover trial
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2008-018-093
    Approval Date 2020-08-31
    Institutional Review Board Name Pusan National University Hospital Institutional Review Board
    Institutional Review Board Address 179, Gudeok-ro, Seo-gu, Busan
    Institutional Review Board Telephone 051-240-7529
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name SANGHUN KIM
    Title Assistant professor
    Telephone +82-51-240-7485
    Affiliation Pusan National University Hospital
    Address 179, Gudeok-ro, Seo-gu, Busan
    Contact Person for Public Queries
    Name Cho Hui HONG
    Title Clinical Researcher
    Telephone +82-51-240-7485
    Affiliation Pusan National University Hospital
    Address 179, Gudeok-ro, Seo-gu, Busan
    Contact Person for Updating Information
    Name SANGHUN KIM
    Title Assistant professor
    Telephone +82-51-240-7485
    Affiliation Pusan National University Hospital
    Address 179, Gudeok-ro, Seo-gu, Busan
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2020-11-30 Actual
    Target Number of Participant 24
    Primary Completion Date 2022-05-26 , Actual
    Study Completion Date 2022-06-30 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Pusan National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-11-30 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Pusan National University Hospital
    Organization Type Medical Institute
    Project ID 202002120001
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Pusan National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Interstitial pulmonary disease (ILD) is a typical symptom of difficulty breathing, including hypoxia during exercise. Due to the restriction of activity due to hypoxia during exercise, the quality of life of the patient is significantly reduced and the possibility of secondary sarcopenia is also increased.
     The prevalence of decreased oxygen saturation during exercise has not been well known due to difficulty in monitoring, but it is so common that less than 88% of oxygen saturation has been confirmed during a 6-minute walk test in about 44% of patients.
     In order to improve the symptoms and functions of patients by improving hypoxia during activities, oxygen generators powered by various types of electricity have been released. A battery rechargeable product that is light enough to carry in a bag (2-3kg) can also be prescribed in Korea. Existing heavy products are often carried in carts, so outdoor activities are limited. Low compliance has been reported in studies of patients with COPD as patients are not aware of their need for oxygen. In the case of ILD patients, oxygen saturation is often lower, but related data are insufficient.
     The purpose of this study is to determine the clinical effect of the pursed lip breathing method in ILD patients with exercise-induced hypoxia confirmed through a randomized crossover study.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Basic Science
    Phase Not applicable
    Intervention Model Cross-over  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Behavioral  
    Intervention Description
    On the first visit, we will obtain consent and screen for research selection criteria. Subjects perform two 6-minute walk tests (30-minute rest) to check for hypoxia during exercise without supplying oxygen while wearing a portable oxygen generator. (Conformity assessment and prevention of learning effects)
    Afterwards, the selected subjects will be educated on how to breathe with pursed lips. Subjects conduct a second visit within one week to retrain their pursed lips breathing technique.
    According to random assignment, a 6-minute walk test is performed while wearing a portable oxygen generator and supplying oxygen (Inogen G3, setting 5; maximum intensity) by applying natural breathing or constricted lip breathing. After that, take a 30-minute break and perform a 6-minute walk test with the second breathing method by crossover assignment.
    Number of Arms 2
    Arm 1

    Arm Label

    pursed lip breathing(PLB) as first

    Target Number of Participant

    12

    Arm Type

    Experimental

    Arm Description

    On the first visit, we will obtain consent and screen for research selection criteria. Subjects perform two 6-minute walk tests (30-minute rest) to check for hypoxia during exercise without supplying oxygen while wearing a portable oxygen generator. (Conformity assessment and prevention of learning effects)
    Afterwards, the selected subjects will be educated on how to breathe with pursed lips. Subjects conduct a second visit within one week to retrain their pursed lips breathing technique.
    According to random assignment, a 6-minute walk test is performed while wearing a portable oxygen generator and supplying oxygen (Inogen G3, setting 5; maximum intensity) by applying constricted lip breathing. 
    After that, take a 30-minute break and perform a 6-minute walk test with the second breathing method by crossover assignment.
    Arm 2

    Arm Label

    Natural Breathing(NB) as first

    Target Number of Participant

    12

    Arm Type

    Experimental

    Arm Description

    On the first visit, we will obtain consent and screen for research selection criteria. Subjects perform two 6-minute walk tests (30-minute rest) to check for hypoxia during exercise without supplying oxygen while wearing a portable oxygen generator. (Conformity assessment and prevention of learning effects)
    Afterwards, the selected subjects will be educated on how to breathe with pursed lips. Subjects conduct a second visit within one week to retrain their pursed lips breathing technique.
    According to random assignment, a 6-minute walk test is performed while wearing a portable oxygen generator and supplying oxygen (Inogen G3, setting 5; maximum intensity) by applying natural breathing 
    After that, take a 30-minute break and perform a 6-minute walk test with the second breathing method by crossover assignment.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    (J00-J99)Diseases of the respiratory system 

    Interstitial Lung Disease
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~No Limit

    Description

    Interstitial Lung disease patients who diagnosed by forced vital capacity (FVC) <80 % or diffusion capacity (DLCO)<80 %, Adult men and women over 20 years old
    Exclusion Criteria
    1. Subjects with severe hypoxia (less than 88% of SpO2) at rest
    2. Subjects who are limited in 6-minute gait test due to musculoskeletal problems of legs or feet
    3. Subjects with limited activity due to heart disease (heart failure NYHA II~IV)
    4. Subjects with pain while walking due to arteriovenous vascular disease
    5. Subjects who do not understand the test due to cognitive decline
    6. Subjects with obesity whose fat thickness of the quadriceps muscle exceeds 1cm
    7. Subjects with muscle disease (myositis, myopathy)
    8. Pregnant women
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    SmO2% change during exercise (SmO2rest-SmO2nadir)
    Timepoint
    Measured twice on the second visit
    Secondary Outcome(s) 1
    Outcome
    6-minute walk distance (6MWD)
    Timepoint
    Screening test at 1st visit, 2 measurements at 2nd visit at 1 week intervals thereafter
    Secondary Outcome(s) 2
    Outcome
    NIRS (deoxy-hemoglobin, deoxy-myoglobin(HHb rest), HHb(peak), oxy-hemoglobin, oxy-myoglobin (HbO2, rest), HbO2(peak), total hemoglobin, myoglobin (THb = HHb+HbO2), Hb difference (Hbdiff = HbO2−HHb)
    Timepoint
    Measured twice on the second visit
    Secondary Outcome(s) 3
    Outcome
    Pulmonary function test (FEV1, FVC, FEV1/FVC)
    Timepoint
    medical records examination
    Secondary Outcome(s) 4
    Outcome
    SpO2% change during exercise (SmO2rest-SmO2nadir)
    Timepoint
    Measured twice on the second visit
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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