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  • Status : Approved
    • First Submitted Date : 2018/07/31
    • Registered Date : 2019/02/11
    • Last Updated Date : 2019/01/18
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1. Background

Background Information
CRIS
Registration Number
KCT0003485 
Unique Protocol ID 1041849-201708-BM-086-02 
Public/Brief Title The Effects of Diaphragm Breathing Training on Ribcage Elevation Distance, Chest Expansion, Diaphragm Thickness, and Superficial Cervical Flexor Muscles Activities in Subjects With Upper Chest Breathing Pattern 
Scientific Title The Effects of Diaphragm Breathing Training on Ribcage Elevation Distance, Chest Expansion, Diaphragm Thickness, and Superficial Cervical Flexor Muscles Activities in Subjects With Upper Chest Breathing Pattern  
Acronym DBTUCB 
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 1041849-201708-BM-086-02 
Approval Date 2017-08-31 
Institutional Review Board  
Name Yonsei University Wonju Institutional Review Board 
Address 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do 
Telephone 033-760-5238 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Heon-seock Cynn 
Title Professor 
Telephone +82-33-760-2427 
Affiliation Yonsei University 
Address 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea 
Contact Person for Public Queries
Name Sil-ah Choi 
Title PhD 
Telephone +82-4030-1057 
Affiliation Yonsei University 
Address 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea 
Contact Person for Updating Information
Name Sil-ah Choi 
Title PhD 
Telephone +82-4030-1058 
Affiliation Yonsei University 
Address 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2017-11-15 , Actual
Target Number of Participant 50
Primary Completion Date 2017-11-30 , Actual
Study Completion Date 2017-11-30 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Yonsei University 
Recruitment Status Completed  
Date of First Enrollment 2017-11-15 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Yonsei University 
Organization Type University  
Project ID 1041849-201708-BM-08 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Yonsei University 
Organization Type University  

7. Study Summary

Study Summary Information
Lay Summary Upper chest breathing makes the diaphragm more linear or flattened and decreases the zone of apposition because the ribs are elevated and externally rotated. Thus, the amount of ribcage elevation increases with upper chest breathing. However, there is no standardized method to measure ribcage elevation distance, and no previous studies have confirmed the relationship between ribcage elevation distance and the diaphragm. Thus, the purposes of this study are to (1) introduce the ribcage elevation distance index (REDI) and investigate the intra- and inter-rater reliability of the REDI, (2) examine the correlation between the REDI and the diaphragm thickness, and (3) evaluate the effects of diaphragm breathing training on ribcage elevation distance, chest expansion, diaphragm thickness, and superficial cervical flexor muscles activities in subjects with upper chest breathing pattern. Fifty subjects with upper chest breathing pattern would participate in this study and the examiner measures the ribcage elevation distance, chest expansion, diaphragm thickness, and muscle activities of sternocleidomastoid (SCM) and anterior scalene for all subjects. The diaphragm breathing training is performed to compare pre-post intervention. For statistical analysis, the intra-class correlation coefficient (ICC), Pearson’s correlation coefficient, and paired t-test are used. It is hypothesized that (1) the REDI would have a good to excellent intra- and inter-rater reliability, (2) there would be a moderate to strong negative correlation between the REDI and diaphragm thickness, and (3) the diaphragm breathing training would result in decreased ribcage elevation distance, decreased chest expansion, increased diaphragm thickness, and decreased superficial cervical flexor muscles activities.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Screening    
Phase Not applicable 
Intervention Model Single Group  
Blinding/Masking Open 
Allocation Not Applicable 
Intervention Type Others (Exercise/Training)
Intervention Description The diaphragm breathing is characterized by the abdominal and lateral ribcage expansion is more apparent than the superior thoracic expansion during inspinration. Subjects were required to place one hand directly over the abdominal area and the other hand on the sternum of upper chest. The examiner indicated that subjects breathe in through the nose and breathe out through the mouth for 3-second for each. At this time, subjects focused on an outward movement of the abdominal area against the one hand during the inspiration and an inward movement of the abdominal area during the expiration while the other hand over the sternum should be remained as still as possible. The principal examiner determined whether the diaphragm breathing was successful, checking the abdominal and lateral costal expansion was predominant. Subjects trained the diaphragm breathing until accomplished 10 repetitions completely under the supervision of examiner.  
Number of Arms
Arm 1 Arm Label Diaphragm breathing training 
Target Number of Participant 50 
Arm Type Experimental 
Arm Description The diaphragm breathing is characterized by the abdominal and lateral ribcage expansion is more apparent than the superior thoracic expansion during inspinration. Subjects were required to place one hand directly over the abdominal area and the other hand on the sternum of upper chest. The examiner indicated that subjects breathe in through the nose and breathe out through the mouth for 3-second for each. At this time, subjects focused on an outward movement of the abdominal area against the one hand during the inspiration and an inward movement of the abdominal area during the expiration while the other hand over the sternum should be remained as still as possible. The principal examiner determined whether the diaphragm breathing was successful, checking the abdominal and lateral costal expansion was predominant. Subjects trained the diaphragm breathing until accomplished 10 repetitions completely under the supervision of examiner. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Symptoms, signs and abnormal clinical and laboratory findings, NEC
 Abnormal diaphragm breathing
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 30 Year
Description Subjects with upper chest breathing pattern characterized by anterosuperior thoracic expansion greater than the abdominal and lateral costal expansion during inspiration were recruited. Two examiners who were physical therapists with 2 and 5 years of research or clinical experiences in physical therapy determined the inclusion criteria through the observation. Two examiners checked 10 inspirations and agreement between both examiners was required.  
Exclusion Criteria Subjects with spinal or chest surgeries, clinical abnormalities of the thoracic cage or vertebral column, acute or chronic neuromusculoskeletal pain in any other body area, and respiratory and cardiac illness were excluded from the study.  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome Ribcage elevation distance 
Timepoint before and after intervention 
Primary Outcome(s) 2 
Outcome Chest expansion 
Timepoint before and after intervention 
Primary Outcome(s) 3 
Outcome Diaphragm thickness 
Timepoint before and after intervention 
Primary Outcome(s) 4 
Outcome Superficial cervical flexor muscles activities 
Timepoint before and after intervention 
Secondary Outcome(s) 1 
Outcome Inter- & Intra-rater reliability of Ribcage elevation distance 
Timepoint before intervention (baseline) 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd Yes
Results Upload
Final Enrollment Number 25
Number of Publication
Results Upload 연구결과 파일저장 Results Donwload  
Date of Posting Results 2018-07-31
Protocol URL or File Upload  
Brief Summary For statistical analysis, the intra-class correlation coefficient (ICC), Pearson’s correlation coefficient, and paired t-test were used. Intra-rater reliability of the REDI was excellent [ICC(3,3): 0.97-0.98] and the inter-rater reliability was good [ICC(2,3): 0.80-0.87] for static position (resting position), the end position of maximal inspiration, and the end position of maximal expiration. There was a little negative correlation between the REDI and diaphragm thickness at static position (r = -0.17, p = 0.47) and the end position of maximal inspiration (r = -0.13, p = 0.47). After diaphragm breathing training, there were significant decrease in REDI, decrease in chest expansion, increase in diaphragm thickness, and decrease in SCM and anterior scalene muscle activities for both static position and the end position of maximal inspiration (p < 0.05).  

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
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