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

NCT04226144 | Terminated

• 1 other identifier: EMTBTALS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Diseases

Keywords

respiratory function tests; deglution disorders

Outcome Measures

Primary Outcomes (3)

• 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).

  from baseline to 24 weeks

• 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)

  from baseline to 24 weeks

• 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)

  from baseline to 24 weeks

Secondary Outcomes (3)

• ALSFR-BR

  from baseline to 24 weeks

• Voice parameters

  from baseline to 24 weeks

• swalloing function

  from baseline to 24 weeks

Study Arms (2)

Breath Stacking Group

ACTIVE COMPARATOR

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

Breath stacking and EMT

EXPERIMENTAL

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

Interventions

Breath Stacking Group DEVICE

Lung recruitment technique using manual bag resuscitation with oronasal mask interface

Also known as: lung recruitment technique

Breath Stacking Group

Breath stacking and EMT DEVICE

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

Also known as: VUP

Breath stacking and EMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Escola Superior de Ciencias da Saude: lead

Study Sites (1)

Hospital de Apoio de Brasilia

Brasília, Federal District, 700000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33005816 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Vinicius Maldaner

  Hospital de Apoio de Brasilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

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

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: January 6, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 1, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)