Effects of an optimised approach to home-based respiratory care in individuals with amyotrophic lateral sclerosis: a study protocol for a randomised controlled trial

Abstract

Introduction: This study aims to investigate the effects of an optimal home-based respiratory care protocol in individuals with amyotrophic lateral sclerosis (ALS).

Methods and analysis: This is a randomised, blinded controlled trial involving patients diagnosed with ALS, both sexes, age between 18 and 80 years. Patients will be randomly allocated into the conventional respiratory care (CRC) group and the optimised respiratory care home-based (ORC) group. Primary outcomes will be peak cough flow, the number of exacerbations and ALS Functional Rating Scale Revised. Secondary outcomes will include chest wall volumes, maximal respiratory pressures, sniff nasal inspiratory pressure, nasal expiratory pressure and forced vital capacity (FVC), forced expiratory volume in the 1st second (FEV₁) and FEV₁/FVC. The CRC group will receive educational information about respiratory care at the clinic. The ORC group will receive conventional care and home-based care. The clinical status of all individuals will be monitored weekly through telephone calls. A 6-month intervention is planned, the outcomes will be assessed every 3 months and 3 and 6 months follow-up after final evaluation. The primary and secondary results will be described as average or median for continuous variables and absolute and relative frequencies for qualitative variables. Treatment effects or differences between the outcomes (baseline, 3 months and 6 months) of the study groups will be analysed using an analysis of variance. The level of significance will be set as p≤0.05.

Ethics and dissemination: The research ethics committee approved the study. It is expected to evaluate respiratory function in patients with ALS in the short, medium and long terms with home-based care protocol applied. The disease's rapid progression is a limitation for performing a long-term clinical study.

Trial registration number: RBR-3z23ts; Pre-results.

Keywords: clinical trials; motor neurone disease; neuromuscular disease; rehabilitation medicine.

Figure 1

Flowchart of allocation and evaluations of intervention protocols.

Figure 2

Therapeutic algorithm for respiratory and non-respiratory events in patients with ALS. SpO₂, 95%-100%; RR, 12bpm-20bpm. ALS, amyotrophic lateral sclerosis; CRC, conventional respiratory care; NIV, non-invasive ventilation; ORC, optimised respiratory care; RR, respiratory rate; SpO₂, peripheral oxygen saturation.