NCT03258944

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

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

First Submitted

Initial submission to the registry

July 21, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

July 21, 2017

Last Update Submit

January 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ventilatory Muscle Strength

    Maximum inspiratory and expiratory pressure

    four weeks

Study Arms (1)

Breath-Stacking

EXPERIMENTAL

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

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.

Breath-Stacking

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 21, 2017

First Posted

August 23, 2017

Study Start

September 1, 2017

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations