Comparison Between Breath Stacking Technique Associated With Expiratory Muscle Training and Breath Stacking Technique in Amyotrophic Lateral Sclerosis Patients: a Randomized Single Blind Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- maximal respiratory pressures
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Breath Stacking Group
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.
Intervention: Breath Stacking Group (Device)
Breath stacking and EMT
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.
Intervention: Breath stacking and EMT (Device)
Outcomes
Primary Outcomes
maximal respiratory pressures
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- swalloing function(from baseline to 24 weeks)
- Voice parameters(from baseline to 24 weeks)
- ALSFR-BR(from baseline to 24 weeks)
Investigators
Vinicius Zacarias Maldaner da silva
PT, PhD
Escola Superior de Ciencias da Saude