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

Abstract

Introduction Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease affecting both upper and lower motor neurons, and lead to respiratory failure. Strategies are suggested to respiratory management in ALS patients, as the breath stacking and Expiratory muscle training (EMT), which have been used as aid to assist cough in neuromuscular disorders. However, the randomized controlled trials performed in ALS patients have not investigated the addiction of EMT together breath stacking in this population. This trial aims to determine if breath stacking plus EMT is more effective than breath stacking alone to decrease the decline rate on the inspiratory/expiratory muscle strength, FVC and voluntary PCF in ALS patients. Methods This parallel-group, assessor-blinded randomized controlled trial, powered for superiority, aims to assess pulmonary function, respiratory muscle strength, peak cough flow as primary outcomes. Forty-two participants are being recruited referral neuromuscular disease center at Brasilia, Brazil. Following baseline testing, participants are randomized using concealed allocation, to receive either: a) breath stacking technique alone or b) breath stacking technique plus EMT. Conclusion There is a lack of evidence regarding the benefit of EMT plus breath stacking in ALS patients. This trial will contribute to evidence currently being generated in national and international trials by implementing and evaluating a respiratory therapy program including two components not yet combined in previous research, for people with ALS involving longer-term follow-up of outcomes. This trial is ongoing and currently recruiting. Trial registration This trial was prospectively registered on the Clinical Trials Registry NCT04226144.

A Pilot Study of the Breath Stacking Technique Associated with Respiratory Muscle Endurance Training in Patients with Amyotrophic Lateral Sclerosis: Videofluoroscopic Findings in the Upper Airway

“…The present article is a cross-sectional study approved by the HC/UFG Ethics Committee (Approval number 3981050-19/08/2018). Participants diagnosed with probable-definite ALS (revised El Escorial criteria) [2,[4][5][6][7][8][9] who were treated at the Tertiary Referral Center for Neuromuscular Diseases of Hospital de Apoio de Brasılia, Brazil [7] were enrolled in this study. Informed consent was obtained from the subjects.…”

“…TR3 was developed based on the previously published physiological and biological principles of ALS [1,2,[4][5][6]. This technique (Table 1) was performed in a single session at a position of 90° and was always executed in the same sequence and by the same therapist.…”

“…The sequence of the technique adopted for TR3 was defined based on the empirical muscle [6], a technique that involves RMET [3] and BS [5,6]. This was chosen because the patient blows against a resistance of 8 cmH 2 O during the expiratory phase which demands high muscle recruitment in the upper airway.…”

“…Epidemiological data were collected as follows: age, sex, Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score [1,2,[4][5][6]9], and duration of adherence to previous TR3 treatment (in weeks). Additionally, pulmonary function tests were performed prior to the intervention.…”

“…Considering the above, Dorça et al [6] developed a novel respiratory therapy named TR3. This therapeutic option, which has recently had its research protocol published, comprises three techniques with BS plus RMET.…”