优化居家呼吸照护方法对肌萎缩侧索硬化症患者的影响：一项随机对照试验的研究方案

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

作者信息

Pondofe Karen, Fregonezi Guilherme A F, Brito Ozana, Dourado Júnior Mario Emilio, Torres-Castro Rodrigo, Resqueti Vanessa R

机构信息

Departamento de Fisioterapia, PneumoCardioVascular Lab/HUOL e Laboratório de Inovação Tecnológica em Reabilitação, Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERH), Universidade Federal do Rio Grande do Norte, Natal, Brazil

出版信息

BMJ Open. 2021 Apr 9;11(4):e042780. doi: 10.1136/bmjopen-2020-042780.

DOI:10.1136/bmjopen-2020-042780

PMID:33837098

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8043034/

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 (FEV) and FEV/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.

摘要

引言

本研究旨在调查最佳家庭呼吸护理方案对肌萎缩侧索硬化症（ALS）患者的影响。

方法与分析

这是一项随机、双盲对照试验，涉及诊断为ALS的患者，不限性别，年龄在18至80岁之间。患者将被随机分配到传统呼吸护理（CRC）组和优化家庭呼吸护理（ORC）组。主要结局指标将是峰值咳嗽流量、病情加重次数和修订的ALS功能评定量表。次要结局指标将包括胸壁容积、最大呼吸压力、嗅吸鼻吸气压力、鼻呼气压力和用力肺活量（FVC）、第1秒用力呼气量（FEV）以及FEV/FVC。CRC组将在诊所接受有关呼吸护理的教育信息。ORC组将接受传统护理和家庭护理。通过电话每周监测所有个体的临床状况。计划进行为期6个月的干预，每3个月评估一次结局，并在最终评估后进行3个月和6个月的随访。连续变量的主要和次要结果将描述为平均值或中位数，定性变量的结果将描述为绝对和相对频率。将使用方差分析来分析研究组结局（基线、3个月和6个月）之间的治疗效果或差异。显著性水平设定为p≤0.05。