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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03258944
Other study ID # VMTBS- HY
Secondary ID
Status Completed
Phase N/A
First received July 21, 2017
Last updated January 16, 2018
Start date September 1, 2017
Est. completion date December 1, 2017

Study information

Verified date January 2018
Source Federal University of Health Science of Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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®)


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 1, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Brazil Universidade Federal de Ciências da Saúde de Porto Alegre Porto Alegre RS

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ventilatory Muscle Strength Maximum inspiratory and expiratory pressure four weeks
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