- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03258944
Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters
Breath-Stacking and Ventilatory Muscle Strength
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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RS
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Porto Alegre, RS, Brazil, 90050-170
- Universidade Federal de Ciências da Saúde de Porto Alegre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilatory Muscle Strength
Time Frame: four weeks
|
Maximum inspiratory and expiratory pressure
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four weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VMTBS- HY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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