Effects of the Breath Stacking Technic in Healthy Individuals

February 1, 2017 updated by: Luciene Aparecida José Vaz, Federal University of Uberlandia
This study aims to Analyze and compere the hemodynamic and respiratory variables before, during and after the applying of technic as well as evaluate respiratory pressures generated during applying of this same technic and correlate them with the effort noticed by device user.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The breath stacking technic (BS) is an inspiratory maneuver used for recruitment of collapsed alveoli and, consequently, improves oxygenation and, therefore, used by respiratory physiotherapy aiming promoting lung re-expansion being. The BS was described by Marini as an attempt of optimizing vital capacity in little co-operative individuals and hemodynamics has been considered a way of incentive spirometry that provides high lung volume, in situations, in which, inspiratory maneuver duration can be as important as the volume reached, composing an alternative incentive of inspiration technic4. The system used is composed by an interface (facial mask) connected to the patient, an inspiratory unidirectional valve and the respiratory branch which is kept occluded during the carrying out of maneuvers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

52 healthy young volunteers The volunteers at the age of 18 to 30, sedentary: absence of neuromuscular and/or cardiac respiratory diseases were included, the smokers, overweight, claustrophobic or the ones with difficulty in carrying out the technic were excluded

Description

Inclusion Criteria:

  • age of 18 to 30, sedentary, absence of neuromuscular and/or cardiac respiratory diseases

Exclusion Criteria:

  • the smokers, overweight, claustrophobic or the ones with difficulty in carrying out the technic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Breath stacking
During initial rest period, the volunteer remained seated for 10' in spontaneous breathing. During carrying out of the breath stacking technic, the volunteer remained seated, being requested to hold the mask on his/her face not allowing air scape, The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds. During the 20 seconds of applying of technic, in the three series the maximum inspiratory and expiratory pressures reached during the carrying out of technic. In the final rest period, right after technic end, the volunteers remained seated for 10 minutes in spontaneous breathing and again the same variables of control at the 10th minute were assessed.
Other: Breath stacking
During initial rest period, the volunteer remained seated for 10' in spontaneous breathing. Right after, the measurement of arterial pressure, of SpO2 (%), of heart rate, of respiratory frequency and applied to a modified effort perception Borg. During carrying out of the breath stacking technic, the volunteer remained seated, being requested to hold the mask on his/her face not allowing air scape, The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds, and the variables were assessement again the same variables of control. In the final rest period, right after technic end, the volunteers remained seated for 10 minutes in spontaneous breathing and again the same variables of control at the 10th minute were assessed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
maximum inspiratory and expiratory pressures
Time Frame: During the intervention. They will be used to verify the average pressures generated during the execution of the technique. Time of the technique equal to 20 seconds.
connected to a manometer from brand Commercial Medica (Brazil) used to measure maximum inspiratory and expiratory pressures generated during carrying out of technic. The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds.
During the intervention. They will be used to verify the average pressures generated during the execution of the technique. Time of the technique equal to 20 seconds.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
modified effort perception Borg scale
Time Frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
applied to a modified effort perception Borg scale with a score from 0 to 10, considering 0 the smallest effort noticed and 10 the biggest effort reported
Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
heart rate
Time Frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
by palpation method of radial artery, of respiratory frequency by direct counting of thoracic movement
Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
peripheral oxygen saturation
Time Frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
through a pulse oximeter
Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
systolic arterial pressure
Time Frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
the measurement of systolic arterial pressure were assessed using an aneroid-type sphygmomanometer
Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
diastolic arterial pressure
Time Frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
the measurement of systolic arterial pressure were assessed using an aneroid-type sphygmomanometer from the brand Lamedial Commercial
Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Uberlandia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEP/UFU 364/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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