Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing

Breathing Exercises Clinical Trial

Official title:

Diaphragm Mobility During Respiratory Exercises With Incentive Spirometry in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997737
• Other study ID #: HSL2008/26
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2009
• Last updated: May 27, 2010
• Start date: October 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2009
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breathing Exercises
• Diaphragm Mobility
• Diaphragmatic Breathing
• Incentive Spirometry
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto de Ensino e Pesquisa do Hospital Sírio Libanês	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ultrasound evaluation of the diaphragm mobility		six - eight months	Yes
Secondary	pulmonary function test		six - eight months	Yes