NCT01551277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

9 months

First QC Date

March 8, 2012

Last Update Submit

March 9, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    ten months

Study Arms (2)

Control Group

PLACEBO COMPARATOR
Other: Placebo-BREATH STACKING

BREATH STACKING

EXPERIMENTAL
Other: BREATH STACKING

Interventions

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.

Control Group

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.

BREATH STACKING

Eligibility Criteria

Age19 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Location

Related Publications (2)

  • 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.

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 12, 2012

Study Start

March 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

March 12, 2012

Record last verified: 2012-03

Locations