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 Purpose:

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.

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis , Neuromuscular Diseases

Study Type:

Interventional

Type of Intervention:

Device

Intervention Name:

Breath Stacking Group, Breath stacking and EMT

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Vinicius Maldaner, Hospital de Apoio de Brasilia

Clinicaltrials.gov ID:

NCT04226144

Neals Affiliated?

No

Coordinating Center Contact Information

VINICIUS ZACARIAS MALDANER D SILVA, PhD / email hidden; JavaScript is required / 6135462517

Full Study Summary:

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 Sponsor:

Escola Superior de Ciencias da Saude

Estimated Enrollment:

50

Estimated Study Start Date:

01 / 06 / 2020

Estimated Study Completion Date:

12 / 30 / 2021

Posting Last Modified Date:

05 / 07 / 2020

Date Study Added to neals.org:

01 / 13 / 2020

Minimum Age:

18 Years

Maximum Age:

N/A

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.

Hospital de Apoio de Brasilia | Recruiting

Vinicius Silva, PhD

Brasilia, DF 700000
Brazil