We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00997737
First Posted: October 19, 2009
Last Update Posted: May 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Sirio-Libanes
  Purpose

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).


Condition Intervention Phase
Diaphragm Mobility Breathing Exercises Incentive Spirometry Diaphragmatic Breathing Device: DB, VI and FI Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Diaphragm Mobility During Respiratory Exercises With Incentive Spirometry in Healthy Individuals

Resource links provided by NLM:


Further study details as provided by Hospital Sirio-Libanes:

Primary Outcome Measures:
  • ultrasound evaluation of the diaphragm mobility [ Time Frame: six - eight months ]

Secondary Outcome Measures:
  • pulmonary function test [ Time Frame: six - eight months ]

Enrollment: 17
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DB, VI and FV
Breathing exercises
Device: DB, VI and FI
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.
Other Names:
  • diaphragmatic exercice
  • incentive spirometry

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997737


Locations
Brazil
Instituto de Ensino e Pesquisa do Hospital Sírio Libanês
São Paulo, SP, Brazil, 01308-050
Sponsors and Collaborators
Hospital Sirio-Libanes
Investigators
Principal Investigator: Wellington P Yamaguti, Master Hospital Sírio Libanês
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wellington Yamaguti, Hospital Sírio Libanês
ClinicalTrials.gov Identifier: NCT00997737     History of Changes
Other Study ID Numbers: HSL2008/26
First Submitted: October 15, 2009
First Posted: October 19, 2009
Last Update Posted: May 28, 2010
Last Verified: October 2009

Keywords provided by Hospital Sirio-Libanes:
incentive spirometry
diaphragm mobility
ultrasound
diaphragmatic breathing

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes