Breath Stacking Technique Associated With Expiratory Muscle Training in Amyotrophic Lateral Sclerosis Patients

Escola Superior de Ciencias da Saude

Status: Terminated

Conditions: Neuromuscular Diseases; Amyotrophic Lateral Sclerosis

Treatments: Device: Breath stacking and EMT; Device: Breath Stacking Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04226144

EMTBTALS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Breath Stacking Group

Active Comparator group

Description:

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.

Treatment:

Device: Breath Stacking Group

Breath stacking and EMT

Experimental group

Description:

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.

Treatment:

Device: Breath stacking and EMT