Back to resultsDiaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing
Primary Purpose
Diaphragm Mobility, Breathing Exercises, Incentive Spirometry
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
DB, VI and FI
Sponsored by
About this trial
This is an interventional treatment trial for Diaphragm Mobility focused on measuring incentive spirometry, diaphragm mobility, ultrasound, diaphragmatic breathing
Eligibility Criteria
Inclusion Criteria:
- Being 18 to 40 years old
- Having a normal body mass index
- Being a non-smoker
- Not knowing the DB and the IS techniques
- Reporting the absence of respiratory diseases.
Exclusion Criteria:
- Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity
- Inability to understand or perform the procedure.
Sites / Locations
- Instituto de Ensino e Pesquisa do Hospital Sírio Libanês
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DB, VI and FV
Arm Description
Breathing exercises
Outcomes
Primary Outcome Measures
ultrasound evaluation of the diaphragm mobility
Secondary Outcome Measures
pulmonary function test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00997737
Brief Title
Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing
Official Title
Diaphragm Mobility During Respiratory Exercises With Incentive Spirometry in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Sirio-Libanes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the present study is to evaluate diaphragm activity during three breathing exercises: diaphragmatic breathing (DB), flow-oriented (Triflo II)incentive spirometry and volume-oriented (Voldyne) incentive spirometry.
Seventeen healthy subjects will be studied (8 man and 9 woman).
Detailed Description
Right diaphragmatic mobility will be evaluated by determining the craniocaudal displacement of the left branch of the portal vein using a B-mode ultrasound device (Logic 500, Pro Series®; General ElectricMedical Systems, Milwaukee, WI, USA). The ultrasound technician will use a 3.5 MHz convex transducer positioned in the right subcostal region, with the incidence angle perpendicular to the craniocaudal axis, in the direction of the inferior vena cava. Next, an intraparenchymal portal branch will be identified in the field of vision and its position will be traced with the curser during the forced inspiration and expiration. The craniocaudal displacement of these points will be considered to be the amount of right diaphragmatic mobility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragm Mobility, Breathing Exercises, Incentive Spirometry, Diaphragmatic Breathing
Keywords
incentive spirometry, diaphragm mobility, ultrasound, diaphragmatic breathing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DB, VI and FV
Arm Type
Experimental
Arm Description
Breathing exercises
Intervention Type
Device
Intervention Name(s)
DB, VI and FI
Other Intervention Name(s)
diaphragmatic exercice, incentive spirometry
Intervention Description
Two modalities of respiratory exercises based on deep and slow inspirations will be used: DB and IS. During DB, the researcher will place one hand slightly below the lower ribs in the abdominal region of the subject and the subject will be instructed to perform inspirations up to the maximum level of volume avoiding rib cage displacement; this recommendation will also be valid for exercises using incentive spirometers. IS will be executed using two different devices: Triflo II and Voldyne.
Primary Outcome Measure Information:
Title
ultrasound evaluation of the diaphragm mobility
Time Frame
six - eight months
Secondary Outcome Measure Information:
Title
pulmonary function test
Time Frame
six - eight months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Being 18 to 40 years old
Having a normal body mass index
Being a non-smoker
Not knowing the DB and the IS techniques
Reporting the absence of respiratory diseases.
Exclusion Criteria:
Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity
Inability to understand or perform the procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wellington P Yamaguti, Master
Organizational Affiliation
Hospital Sírio-Libanês
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Ensino e Pesquisa do Hospital Sírio Libanês
City
São Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
21225177
Citation
Yamaguti WP, Sakamoto ET, Panazzolo D, Peixoto Cda C, Cerri GG, Albuquerque AL. Diaphragmatic mobility in healthy subjects during incentive spirometry with a flow-oriented device and with a volume-oriented device. J Bras Pneumol. 2010 Nov-Dec;36(6):738-45. doi: 10.1590/s1806-37132010000600011. English, Portuguese.
Results Reference
derived
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Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing
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