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CompletedNCT03258944Updated Jan 18, 2018

Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters

An interventional study of Breath-Stacking in Muscle Weakness, sponsored by Federal University of Health Science of Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-18.

Sponsored by Federal University of Health Science of Porto Alegre · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years to 24 Years
Sex
All
01

Study summary

In several diseases in which muscle weakness is a determining factor for morbidity and mortality, inspiratory muscle training has been shown to be useful in improving the function of ventilatory muscles, delaying or minimizing the development of complications due to the reduction of inspiratory muscle strength.

The breath-stacking technique emerges as an easily applicable alternative, and it can be used in poorly collaborative patients. The technique described in the literature aims to increase pulmonary volumes.

This gain occurs with the coupling of a silicone mask on the patient's face, a unidirectional valve and with the expiratory branch occluded. Thus, inspirations occur sequentially in this medium, generating pulmonary hyperinflation and increasing the contractility power of the expiratory muscles, which are fundamental for coughing. This hyperinflation also improves the peripheral air distribution in the lungs by increasing intrathoracic pressure.

The objective of this study is to evaluate the effect of the breath-stacking (BS) technique on the ventilatory muscle strength of young and healthy individuals.

Read the detailed description

Initially, participants will be submitted to a learning session on the evaluation of ventilatory muscle strength and the breath-stacking technique. Between 24-72 hours after the learning, the evaluation of the muscular muscular strength will be performed through the maximal inspiratory pressure (MIP) and the maximum expiratory pressure (MEP). PI max will be measured from a maximum expiration; While PE max will be measured from a maximum inspiration, using a digital manovacuometer (MVD 300®)

02

Conditions studied

  • Muscle Weakness

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03

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No signs and symptoms of pulmonary diseases, normal ventilatory muscle strength and agreement to participate and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Presenting neuromuscular diseases, claustrophobia, ruptured eardrum, history of spontaneous pneumothorax and playing wind instruments or being a singer. Sample loss will be considered as non-attendance at all training sessions.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Breath-Stacking

    Participants will be seated, with their elbows resting on the table, holding the face mask attached to a T-tube and a one-way valve. They will be instructed to inspire and force the expiration inside the mask. The training will be conducted three times a week for a period of four weeks, totaling twelve sessions. The breath-stacking application protocol will consist of three three-minute series, with a three-minute recovery interval between each series, obtaining a total time of fifteen minutes in each session

    Other: Breath-Stacking

Interventions

  • OtherBreath-Stacking

    Participants will be seated, with their elbows resting on the table, holding the face mask attached to a T-tube and a one-way valve. They will be instructed to inspire and force the expiration inside the mask. The training will be conducted three times a week for a period of four weeks, totaling twelve sessions. The breath-stacking application protocol will consist of three three-minute series, with a three-minute recovery interval between each series, obtaining a total time of fifteen minutes in each session.

05

What researchers measure

Primary outcomes

  1. Ventilatory Muscle Strength

    Maximum inspiratory and expiratory pressure

    Time frame: four weeks

06

Study locations

1 site
  • Universidade Federal de Ciências da Saúde de Porto Alegre
    Porto Alegre, RS 90050-170, Brazil
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03258944
Lead sponsor
Federal University of Health Science of Porto Alegre
Responsible party
Fabrício Edler Macagnan (PhD, Federal University of Health Science of Porto Alegre) — Principal investigator
First posted
Aug 23, 2017
Start date
Sep 1, 2017
Primary completion
Nov 1, 2017
Completion
Dec 1, 2017
Last update
Jan 18, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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