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

Primary Purpose

Amyotrophic Lateral Sclerosis, Neuromuscular Diseases

Status

Terminated

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Breath Stacking Group

Breath stacking and EMT

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring respiratory function tests, deglution disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital de Apoio de Brasilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Breath Stacking Group

Breath stacking and EMT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

maximal respiratory pressures

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).

Peak cough flow

change of decline rate of peak cough flow (PCF) assessed by analogic peak cough flow meter (Respironics-Philips Health Care,PA,USA)

Forced Vital Capacity and Slow Vital Capacity

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)

Secondary Outcome Measures

ALSFR-BR

change of decline rate of Amyotrofic Lateral Sclerosis Functional Revised Scale Brazil (ALSFR-BR)

Voice parameters

change of Maximum Phonation Time

swalloing function

change of The Eating Assessment Tool-10 (EAT-10)

Full Information

NCT ID

NCT04226144

First Posted

January 9, 2020

Last Updated

April 1, 2023

Sponsor

Escola Superior de Ciencias da Saude

1. Study Identification

Unique Protocol Identification Number

NCT04226144

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Terminated

Why Stopped

COVID 19 pandemy

Study Start Date

January 6, 2020 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Escola Superior de Ciencias da Saude

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis, Neuromuscular Diseases

Keywords

respiratory function tests, deglution disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

two-arm, parallel (1:1), superiority, blinded-assessor randomized controlled trial

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Breath Stacking Group

Arm Type

Active Comparator

Arm Description

Arm Title

Breath stacking and EMT

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Breath Stacking Group

Other Intervention Name(s)

lung recruitment technique

Intervention Description

Lung recruitment technique using manual bag resuscitation with oronasal mask interface

Intervention Type

Device

Intervention Name(s)

Breath stacking and EMT

Other Intervention Name(s)

VUP

Intervention Description

Lung recruitment technique with one way valve with counter resistance during all expiratory phase

Primary Outcome Measure Information:

Title

maximal respiratory pressures

Description

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).

Time Frame

from baseline to 24 weeks

Title

Peak cough flow

Description

change of decline rate of peak cough flow (PCF) assessed by analogic peak cough flow meter (Respironics-Philips Health Care,PA,USA)

Time Frame

from baseline to 24 weeks

Title

Forced Vital Capacity and Slow Vital Capacity

Description

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)

Time Frame

from baseline to 24 weeks

Secondary Outcome Measure Information:

Title

ALSFR-BR

Description

change of decline rate of Amyotrofic Lateral Sclerosis Functional Revised Scale Brazil (ALSFR-BR)

Time Frame

from baseline to 24 weeks

Title

Voice parameters

Description

change of Maximum Phonation Time

Time Frame

from baseline to 24 weeks

Title

swalloing function

Description

change of The Eating Assessment Tool-10 (EAT-10)

Time Frame

from baseline to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vinicius Maldaner

Organizational Affiliation

Hospital de Apoio de Brasilia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Apoio de Brasilia

City

Brasilia

State/Province

ZIP/Postal Code

700000

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33005816

Citation

Dorca A, Alcantara LA, Diniz DS, Sarmet M, Menezes Mateus SR, Franco Oliveira LV, Franco H, Maldaner V. Comparison between breath stacking technique associated with expiratory muscle training and breath stacking technique in amyotrophic lateral sclerosis patients: Protocol for randomized single blind trial. Contemp Clin Trials Commun. 2020 Sep 2;19:100647. doi: 10.1016/j.conctc.2020.100647. eCollection 2020 Sep.

Results Reference

derived

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

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