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

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04226144
• Other study ID #: EMTBTALS
• Status: Terminated
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2023
• Source: Escola Superior de Ciencias da Saude
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Neuromuscular Diseases
• Sclerosis

Intervention

Device:
• Breath Stacking Group
Lung recruitment technique using manual bag resuscitation with oronasal mask interface
• Breath stacking and EMT
Lung recruitment technique with one way valve with counter resistance during all expiratory phase

Locations

Country	Name	City	State
Brazil	Hospital de Apoio de Brasilia	Brasilia	DF

Sponsors (1)

Lead Sponsor	Collaborator
Escola Superior de Ciencias da Saude

Country where clinical trial is conducted

Brazil, 

Outcome

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