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Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Breath-Stacking
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Muscle Weakness

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal de Ciências da Saúde de Porto Alegre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breath-Stacking

Arm Description

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

Outcomes

Primary Outcome Measures

Ventilatory Muscle Strength
Maximum inspiratory and expiratory pressure

Secondary Outcome Measures

Full Information

First Posted
July 21, 2017
Last Updated
January 16, 2018
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03258944
Brief Title
Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters
Official Title
Breath-Stacking and Ventilatory Muscle Strength
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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®)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breath-Stacking
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Breath-Stacking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventilatory Muscle Strength
Description
Maximum inspiratory and expiratory pressure
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidade Federal de Ciências da Saúde de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050-170
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters

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