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The impact of voluntary breathing on the balance ability in healthy young adults.

Status Approved

  • First Submitted Date

    2021/03/18

  • Registered Date

    2021/03/25

  • Last Updated Date

    2021/03/18

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
    KCT0006026
    Unique Protocol ID 1044396-202101-HR-003-01
    Public/Brief Title The effect of the type of breathing on the ability to balance.
    Scientific Title The impact of voluntary breathing on the balance ability in healthy young adults.
    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 1044396-202101-HR-003-01
    Approval Date 2021-02-17
    Institutional Review Board Name Gachon University Institutional Review Board
    Institutional Review Board Address 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do
    Institutional Review Board Telephone 031-750-8566
    Data Monitoring Committee
  • 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 Hwiyoung Cho
    Title Professor
    Telephone +82-31-750-8566
    Affiliation Gachon University
    Address 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
    Contact Person for Public Queries
    Name SungHyeon Kim
    Title research worker
    Telephone +82-31-750-8566
    Affiliation Gachon University
    Address 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
    Contact Person for Updating Information
    Name Hwiyoung Cho
    Title Professor
    Telephone +82-31-750-8566
    Affiliation Gachon University
    Address 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
  • 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 Recruiting
    Date of First Enrollment 2021-03-02 Actual
    Target Number of Participant 40
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Gachon University
    Recruitment Status Recruiting
    Date of First Enrollment 2021-03-02 ,
  • 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 Gachon University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Gachon University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Balance refers to the ability to maintain the body's center of gravity within the support surface with minimal postural fluctuations, and this balance ability allows the body to remain in a state of equilibrium.
    In order to maintain the human body's equilibrium, the ability to perceive the position of the body relative to the surrounding environment is required, and for this, the roles of various sensory organs are required.
    Therefore, in previous studies including evaluation of balance ability, in general, balance ability measurement has been conducted by controlling factors that may affect maintaining equilibrium due to differences in sensory information input such as posture and gaze of arms and legs. .
    In recent studies, it has been reported that voluntary breathing can affect postural control by altering the activity of the motor cortex of the brain.
    In addition, it is reported that the effect of breathing on balance will only appear in the elderly and patients with low back pain, and that in the case of healthy adults, internal fluctuations caused by breathing will be canceled through proactive posture control.
    However, most of the respiratory muscles do not only act as a role for breathing, but also perform the role of generating body movements at the same time.
    For this reason, it is possible that voluntary control of the respiratory muscles may have an effect on maintaining equilibrium even in young adults, and in particular, it may have a greater influence in more challenging situations such as single leg standing.
    However, other than the research on the elderly, the effect on various age groups has not been clearly revealed.
    In evaluating balance ability, evidence is needed for respiratory control for accurate measurement.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Cross-sectional  
    Target Number of Participant 40
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    healthy adults

    Cohort/Group Description

    Subjects were evaluated for their balance ability under three breathing conditions (neutral breathing, thoracic breathing, and abdominal breathing).
    Type of breath
    1. Neutral breathing: normal breathing in a comfortable state
    2. Thoracic breathing: Minimizing the use of abdominal muscles and breathing using the rib cage
    3. Abdominal breathing: minimizing the use of muscles in the chest and breathing using the abdomen
    
    Balance measure (30 seconds)
    1. Balance ability during standing
    2. Balance ability during one leg standing
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Among the residents of Incheon,healthy adults
    Sampling Method
    Simple Random Sampling: A Randomized selection of healthy adults
    Condition(s)/Problem(s)    Not Applicable-Quality of life 

    Healthy Volunteers
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    2Year~No Limit

    Description

    1) healthy adult men and women
    2) A sedentary person who does not exercise at least 3 times a week for more than 30 minutes
    Exclusion Criteria
    1) Smokers and persons with abnormal lung function
    2) neurological and musculoskeletal diseases
    3) cannot maintain one step stand for more than 20 seconds
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    balance ability
    Timepoint
    neutral breathing, thoracic breathing, abdominal breathing
    Secondary Outcome(s) 1
    Outcome
    muscle activity
    Timepoint
    neutral breathing, thoracic breathing, abdominal breathing
  • 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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