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
CRIS Registration Number |
KCT0006026 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Gachon University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Gachon University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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 |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Among the residents of Incheon,healthy adults |
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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)
Type of Primary Outcome | Not applicable | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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