Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing

NCT00997737 | Completed Phase 1 DMC

• 1 other identifier: HSL2008/26
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Diaphragm Mobility; Breathing Exercises; Incentive Spirometry; Diaphragmatic Breathing

Keywords

incentive spirometry; diaphragm mobility; ultrasound; diaphragmatic breathing

Outcome Measures

Primary Outcomes (1)

• ultrasound evaluation of the diaphragm mobility

  six - eight months

Secondary Outcomes (1)

• pulmonary function test

  six - eight months

Study Arms (1)

DB, VI and FV

EXPERIMENTAL

Breathing exercises

Device: DB, VI and FI

Interventions

DB, VI and FI DEVICE

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.

Also known as: diaphragmatic exercice, incentive spirometry

DB, VI and FV

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity
• Inability to understand or perform the procedure.

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Instituto de Ensino e Pesquisa do Hospital Sírio Libanês

São Paulo, São Paulo, 01308-050, Brazil

Location

Related Publications (1)

• 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.

  PMID: 21225177 DERIVED

Study Officials

• Wellington P Yamaguti, Master

  Hospital Sírio-Libanês

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 19, 2009
• Study Start: October 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 28, 2010

Record last verified: 2009-10

Locations

BR (1)