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
CRIS Registration Number |
KCT0005440 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Pusan National University Hospital |
Organization Type | Medical Institute |
Project ID | 202002120001 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Pusan National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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)
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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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