Breath Stacking Technique Associated With Expiratory Muscle Training in Amyotrophic Lateral Sclerosis Patients

April 1, 2023 updated by: Vinicius Zacarias Maldaner da silva, Escola Superior de Ciencias da Saude

Comparison Between Breath Stacking Technique Associated With Expiratory Muscle Training and Breath Stacking Technique in Amyotrophic Lateral Sclerosis Patients: a Randomized Single Blind Trial

it will be conducted a randomized parallel controlled trial with patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) to compare two techniques to lung recruitment and cough augmentation, to assess their effects on pulmonary function, global functionally, swallowing and ability to speech in these population.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

age over 18 years preserved cognition, evidenced by a score greater than or equal to 24 points in the Mini-Mental Status Exam; no barium allergies; without tracheostomy or invasive mechanical ventilation; no diaphragmatic pacemaker and without associated respiratory disease.Participants are excluded if they have pregnancy; previous kidney disease or other concomitant diseases; respiratory diseases and hospitalization in intensive care units (ICUs) during the study.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • DF
      • Brasilia, DF, Brazil, 700000
        • Hospital de Apoio de Brasilia

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of neuromuscular disease confirmed by neurologists at the referral center for neuromuscular diseases at Brasília prior to screening for recruitment
  • age over 18 years
  • preserved cognition, evidenced by a score greater than or equal to 24 points in the Mini-Mental Status Exam;
  • no barium allergies
  • without tracheostomy or invasive mechanical ventilation
  • no diaphragmatic pacemaker
  • without associated respiratory disease

Exclusion Criteria:

  • pregnancy
  • previous kidney disease or other concomitant diseases .respiratory diseases and hospitalization in intensive care units (ICUs) during the study.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Breath Stacking Group
The lungs are inflated as fully as possible by stacking successive breaths without expiration until the patients' maximal inspiratory capacity (MIC). The participant will be instructed to sustain the air in the lung, closing the glottis. Once the lungs are maximally inflated, the compressed air volume is released under expiratory muscle force, thus generating a cough with lung and chest wall recoil. They will perform 5-8 cycles of breath stacking per session, stacking 3-5 breaths per cycle.
Device: Breath Stacking Group
Lung recruitment technique using manual bag resuscitation with oronasal mask interface
Other Names:
  • lung recruitment technique
Experimental: Breath stacking and EMT
This group will perform the breath stacking technique in addiction with EMT. It will change the one-way valve in this group to VUP (Lumiar, Sao Paulo, Brazil) one-way valve, which allows the patients blow out the air with a counter resistance during all expiratory phase. The initial expiratory pressure will be 8 cmH2O, and could be changed at each visit according to participants' tolerance (either report easy or difficult to exhale assessed by research coordinators. The participants are encouraged to blow out the most slowly that they can do it.
Device: Breath stacking and EMT
Lung recruitment technique with one way valve with counter resistance during all expiratory phase
Other Names:
  • VUP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal respiratory pressures
Time Frame: from baseline to 24 weeks
change of decline rate of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) assessed by digital pressure (MVD-500 V.1.1 Microhard System,Porto Alegre, Brazil).
from baseline to 24 weeks
Peak cough flow
Time Frame: from baseline to 24 weeks
change of decline rate of peak cough flow (PCF) assessed by analogic peak cough flow meter (Respironics-Philips Health Care,PA,USA)
from baseline to 24 weeks
Forced Vital Capacity and Slow Vital Capacity
Time Frame: from baseline to 24 weeks
Change of decline rate of Forced Vital Capacity (FVC) and Slow Vital Capacity (SVC) predicted by brazilian population assessed by digital spirometer (Vitalgraph, London, UK)
from baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALSFR-BR
Time Frame: from baseline to 24 weeks
change of decline rate of Amyotrofic Lateral Sclerosis Functional Revised Scale Brazil (ALSFR-BR)
from baseline to 24 weeks
Voice parameters
Time Frame: from baseline to 24 weeks
change of Maximum Phonation Time
from baseline to 24 weeks
swalloing function
Time Frame: from baseline to 24 weeks
change of The Eating Assessment Tool-10 (EAT-10)
from baseline to 24 weeks

Collaborators and Investigators

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

Sponsor

Escola Superior de Ciencias da Saude

Investigators

  • Principal Investigator: Vinicius Maldaner, Hospital de Apoio de Brasilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 6, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 1, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMTBTALS

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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