Amyotrophic Lateral Sclerosis, Neuromuscular Diseases
Conditions
Keywords
respiratory function tests, deglution disorders
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.
Interventions
DEVICEBreath Stacking Group
Lung recruitment technique using manual bag resuscitation with oronasal mask interface
DEVICEBreath stacking and EMT
Lung recruitment technique with one way valve with counter resistance during all expiratory phase
Sponsors
Escola Superior de Ciencias da Saude
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
two-arm, parallel (1:1), superiority, blinded-assessor randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Brazil
Outcome results
None listed