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

Not Applicable

Terminated

• Conditions: Amyotrophic Lateral Sclerosis; Neuromuscular Diseases

• Registration Number: NCT04226144
• Lead Sponsor: Escola Superior de Ciencias da Saude

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.

Study Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Primary Completion: 2021-08-31
• Study Completion: 2022-12-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-01
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
maximal respiratory pressures	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).
Peak cough flow	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)
Forced Vital Capacity and Slow Vital Capacity	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Apoio de Brasilia; 🇧🇷 Brasilia, DF, Brazil