Patients with amyotrophic lateral sclerosis (ALS) experience respiratory complications from their disease that can rapidly worsen and ultimately contribute to an early risk of death. In a paper published in the BMJ Open, researchers from South America presented a protocol for a randomized trial to study the effects of an optimized home-based respiratory care approach in patients with ALS.
In their paper, the study researchers stated that they plan to compare the outcomes associated with conventional respiratory care with a home-based optimized respiratory care regimen in adult patients with ALS.
The optimized home-based respiratory care model in the randomized study will incorporate respiratory care education during quarterly visits to the hospital. Patients will also receive home visits by a physiotherapist each week. Physiotherapists will provide patients and caregivers “settings to use and improve [noninvasive] ventilation, bronchial hygiene techniques, aspiration of upper airways and assisted coughing through ventilation by mechanical insufflation-exhaustion,” as well as air stacking.
In contrast, the conventional care group will receive only quarterly education sessions at the hospital and physiotherapist-provided settings to use or improve noninvasive ventilation and mask adaptation at the quarterly visits.
Study researchers will assess peak cough flow, the number of exacerbations, and ALS Functional Rating Scale Revised to determine the progression of disease and how ALS interferes with activities of daily living.
They will also examine chest wall volumes, sniff nasal inspiratory pressure, nasal expiratory pressure and forced vital capacity (FVC), maximal respiratory pressures, forced expiratory volume in 1 second (FEV1), and FEV1/forced vital capacity.
Overall, patients will undergo their assigned intervention for a planned time period of 6 months, while the study outcomes will be evaluated every 3 months until the first year following the start of interventions, as well as 3 and 6 months following the final assessment.
The study researchers hope the findings from this study will support “the importance of home-based physiotherapy with [specialized] assistance,” as they believe that such “a well-implemented therapeutic [program] will reduce the morbidity and mortality rates of patients with ALS.”
Pondofe K, Fregonezi GAF, Brito O, Júnior MED, Torres-Castro R, Resqueti VR. Effects of an optimised approach to home-based respiratory care in individuals with amyotrophic lateral sclerosis: a study protocol for a randomised controlled trial. BMJ Open. 2021;11(4):e042780. doi:10.1136/bmjopen-2020-042780