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Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity

Primary Purpose

Morbidly Obese

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Placebo-BREATH STACKING
BREATH STACKING
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbidly Obese

Eligibility Criteria

19 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women aged 19-60 years
  • BMI ≥ 40 kg/m2

Exclusion Criteria:

  • Women with chronic lung disease
  • Smokers
  • Neuromuscular disease
  • Disability in performing the procedures

Sites / Locations

  • Universidade Federal de Pernambuco

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

BREATH STACKING

Arm Description

Outcomes

Primary Outcome Measures

Chest wall regional volume
We considered as primary outcome regional tidal volumes: total current volume of the chest cavity (Vc), changes in tidal volume of pulmonary rib cage (ΔVc, ctp), tidal volume variation of the abdominal rib cage (ΔVc, CTA) and abdominal tidal volume (ΔVc, ab), and secondary outcome Inspiratory capacity (IC).

Secondary Outcome Measures

Full Information

First Posted
March 8, 2012
Last Updated
March 9, 2012
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT01551277
Brief Title
Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity
Official Title
Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity: Clinical Trial Controlled and Randominzado
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objectives: To evaluate the effects of the technique of Breath Stacking (BS) in the distribution of ventilation in the chest in women with morbid obesity. Methods: Randomized clinical trial, blinded, and controlled with 32 women (BMI ≥ 40kg/m2), separated into two groups: control (GC) with n = 16 and 41.94 ± 9.38 years and group Breath Stacking (GBS) , n = 16 and 40.38 ± 10.16 years. Optoelectronic plethysmography (POE) was used to assess lung ventilation. For the BS technique was used to mask the expiratory branch occluded and Wright spirometer. GBS held three techniques with an interval of three minutes. The GC used the same circuit without the occlusion of the expiratory branch. Results: GBS was found to be higher in the contribution of tidal volume (VT) into the chest circumference (p = 0.04) and decrease in abdominal compartment (p = 0.03), whereas the CG showed no difference in distribution. Spirometric variables: FEV1 (%), FVC (%), FEV1/FVC (%), VC and CI showed no difference before and after the technical BS and GBS in the GC. Conclusions: The technique BS altered the distribution pattern of regional ventilation, resulting in greater contribution in lung volume in the lower rib cage, corresponding to activity of the diaphragm, with redistribution of volume between compartments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbidly Obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Title
BREATH STACKING
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Placebo-BREATH STACKING
Intervention Description
The control group used the same circuit in the intervention group, but without occlusion of the expiratory branch and followed the same protocol to capture the images, ie, basal respiration for five minutes, then three periods of breathing through the mask, the equivalent time the period of technical BS, and five minutes of respiration. The volunteers were instructed to maintain respiration during the period they were using the mask.
Intervention Type
Other
Intervention Name(s)
BREATH STACKING
Intervention Description
In the intervention group used a silicon mask, involving the nose and mouth with two outputs, one containing the Wright spirometer MARK 8 analog output and the other was occluded. It was explained that the mask would only allow the air entering during inspiration, and that should inspire the volunteer gradually filling the lungs with air until you feel that completely filled with an average time of 20 seconds, as shown in figure 1 obtained during the method of BS. The end of the technique would be in two situations: when the volunteer asked for it through a hand gesture, or when prearranged by Wright spirometer, was observed by the researcher that there was no change in the inspired volume.
Primary Outcome Measure Information:
Title
Chest wall regional volume
Description
We considered as primary outcome regional tidal volumes: total current volume of the chest cavity (Vc), changes in tidal volume of pulmonary rib cage (ΔVc, ctp), tidal volume variation of the abdominal rib cage (ΔVc, CTA) and abdominal tidal volume (ΔVc, ab), and secondary outcome Inspiratory capacity (IC).
Time Frame
ten months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women aged 19-60 years BMI ≥ 40 kg/m2 Exclusion Criteria: Women with chronic lung disease Smokers Neuromuscular disease Disability in performing the procedures
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
9018522
Citation
Cala SJ, Kenyon CM, Ferrigno G, Carnevali P, Aliverti A, Pedotti A, Macklem PT, Rochester DF. Chest wall and lung volume estimation by optical reflectance motion analysis. J Appl Physiol (1985). 1996 Dec;81(6):2680-9. doi: 10.1152/jappl.1996.81.6.2680.
Results Reference
result
PubMed Identifier
19559105
Citation
Chlif M, Keochkerian D, Choquet D, Vaidie A, Ahmaidi S. Effects of obesity on breathing pattern, ventilatory neural drive and mechanics. Respir Physiol Neurobiol. 2009 Sep 30;168(3):198-202. doi: 10.1016/j.resp.2009.06.012. Epub 2009 Jun 24.
Results Reference
result

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Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity

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