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COVID 19 pandemy
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breath Stacking Group | Active Comparator | The lungs are inflated as fully as possible by stacking successive breaths without expiration until the patients' maximal inspiratory capacity (MIC). The participant will be instructed to sustain the air in the lung, closing the glottis. Once the lungs are maximally inflated, the compressed air volume is released under expiratory muscle force, thus generating a cough with lung and chest wall recoil. They will perform 5-8 cycles of breath stacking per session, stacking 3-5 breaths per cycle. |
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| Breath stacking and EMT | Experimental | This group will perform the breath stacking technique in addiction with EMT. It will change the one-way valve in this group to VUP (Lumiar, Sao Paulo, Brazil) one-way valve, which allows the patients blow out the air with a counter resistance during all expiratory phase. The initial expiratory pressure will be 8 cmH2O, and could be changed at each visit according to participants' tolerance (either report easy or difficult to exhale assessed by research coordinators. The participants are encouraged to blow out the most slowly that they can do it. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath Stacking Group | Device | Lung recruitment technique using manual bag resuscitation with oronasal mask interface |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ALSFR-BR | change of decline rate of Amyotrofic Lateral Sclerosis Functional Revised Scale Brazil (ALSFR-BR) | from baseline to 24 weeks |
| Voice parameters | change of Maximum Phonation Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinicius Maldaner | Hospital de Apoio de Brasilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Apoio de Brasilia | BrasÃlia | Federal District | 700000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33005816 | Derived | 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. |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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two-arm, parallel (1:1), superiority, blinded-assessor randomized controlled trial
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| Breath stacking and EMT | Device | Lung recruitment technique with one way valve with counter resistance during all expiratory phase |
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| from baseline to 24 weeks |
| swalloing function | change of The Eating Assessment Tool-10 (EAT-10) | from baseline to 24 weeks |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |