NCT03042403

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

January 24, 2017

Last Update Submit

February 1, 2017

Conditions

Keywords

hemodynamicsphysiotherapybreath stacking

Outcome Measures

Primary Outcomes (1)

  • maximum inspiratory and expiratory pressures

    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 Outcomes (5)

  • modified effort perception Borg scale

    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

    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

    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

    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

    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.

Study Arms (1)

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

Interventions

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.

Breath stacking

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Celia R Lopes

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

January 24, 2017

First Posted

February 3, 2017

Study Start

October 1, 2012

Primary Completion

January 1, 2013

Study Completion

September 1, 2013

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share