Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing

May 27, 2010 updated by: Hospital Sirio-Libanes

Diaphragm Mobility During Respiratory Exercises With Incentive Spirometry in Healthy Individuals

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01308-050
        • Instituto de Ensino e Pesquisa do Hospital Sírio Libanês

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ultrasound evaluation of the diaphragm mobility
Time Frame: six - eight months
six - eight months

Secondary Outcome Measures

Outcome Measure
Time Frame
pulmonary function test
Time Frame: six - eight months
six - eight months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sirio-Libanes

Investigators

  • Principal Investigator: Wellington P Yamaguti, Master, Hospital Sírio-Libanês

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 18, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSL2008/26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe