Clinical trial NCT04226144: 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
Overall status: TERMINATED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Neuromuscular Diseases
Keywords: respiratory function tests
deglution disorders
Lead sponsor: Escola Superior de Ciencias da Saude
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-arm, parallel (1:1), superiority, blinded-assessor randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: maximal respiratory pressures
timeFrame: from baseline to 24 weeks
measure: Peak cough flow
timeFrame: from baseline to 24 weeks
measure: Forced Vital Capacity and Slow Vital Capacity
timeFrame: from baseline to 24 weeks
Secondary outcomes:
measure: ALSFR-BR
timeFrame: from baseline to 24 weeks
measure: Voice parameters
timeFrame: from baseline to 24 weeks
measure: swalloing function
timeFrame: from baseline to 24 weeks
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital de Apoio de Brasilia
state: DF
Study officials:
affiliation: Hospital de Apoio de Brasilia
name: Vinicius Maldaner
role: PRINCIPAL_INVESTIGATOR
References:
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.