Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing

This study has been completed.
Sponsor:
Information provided by:
Hospital Sirio-Libanes
ClinicalTrials.gov Identifier:
NCT00997737
First received: October 15, 2009
Last updated: May 27, 2010
Last verified: October 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pulmonary function test [ Time Frame: six - eight months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hospital Sirio-Libanes

Additional 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
Study First Received: October 15, 2009
Last Updated: May 27, 2010
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014