Majd Sally, Apps Lindsay D, Hudson Nicky, Hewitt Stacey, Eglinton Elizabeth, Murphy Anna, Bradding Peter, Singh Sally, Green Ruth, Evans Rachael
Centre for Exercise Rehabilitation Science, Leicester, UK Leicester Respiratory Biomedical Research Unit, Glenfield Hospital, Leicester, UK Infection, Immunity and Inflammation, University of Leicester, Leicester, UK.
Centre for Exercise Rehabilitation Science, Leicester, UK Leicester Respiratory Biomedical Research Unit, Glenfield Hospital, Leicester, UK.
BMJ Open. 2016 Mar 23;6(3):e010574. doi: 10.1136/bmjopen-2015-010574.
Pulmonary rehabilitation with core components of exercise training and multiprofessional education is an integral part of the management of patients with chronic lung disease. International guidelines for individuals with asthma recommend exercise as exercise improves symptoms, indices of cardiopulmonary efficiency, health status and psychosocial outcome. However, there is little published evidence evaluating safety and acceptability of exercise training for individuals with severe asthma and there are concerns regarding exercise-induced asthma. We propose a feasibility study for a multicentre randomised controlled trial (RCT) of asthma-tailored pulmonary rehabilitation (asthma-tailored PR) versus usual care in individuals with severe asthma.
The study will be conducted in three stages. Adults with severe asthma will be included if they have persistent symptoms despite being at step 4 or 5 of the British Thoracic Society guidelines. Stage 1: semistructured interviews will be used in a sample of 20-30 individuals with severe asthma to understand the experience and attitudes of this population towards exercise. Stage 2: eight focus groups of at least six healthcare professionals involved in the care of patients with severe asthma will be conducted to understand their attitudes towards exercise for this population. Stage 3: a small-scale RCT of the proposed multicentre RCT of asthma-tailored PR versus usual care for individuals with severe asthma will be conducted. The primary outcome measures will be recruitment, retention and adverse event rates. Semistructured interviews with participants of stage 3 will be used to identify further barriers or facilitators to participation in PR and the trial. Thematic analysis will be used for the interpretation of all interviews.
The study results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee East Midland approved the study protocol.
ISRCTN96143888.
以运动训练和多专业教育为核心组成部分的肺康复是慢性肺病患者管理的一个重要组成部分。针对哮喘患者的国际指南推荐运动，因为运动可改善症状、心肺效率指标、健康状况和心理社会结局。然而，几乎没有已发表的证据评估重度哮喘患者运动训练的安全性和可接受性，并且人们对运动诱发的哮喘存在担忧。我们提议针对重度哮喘患者进行一项多中心随机对照试验（RCT），比较哮喘定制肺康复（哮喘定制PR）与常规治疗的可行性研究。
该研究将分三个阶段进行。重度哮喘的成年人如果尽管处于英国胸科学会指南的第4或5步仍有持续症状，将被纳入研究。第1阶段：将对20 - 30名重度哮喘患者进行半结构化访谈，以了解该人群对运动的体验和态度。第2阶段：将对至少六名参与重度哮喘患者护理的医疗保健专业人员进行八个焦点小组访谈，以了解他们对该人群运动的态度。第3阶段：将针对重度哮喘患者进行一项提议的多中心RCT的小规模RCT，比较哮喘定制PR与常规治疗。主要结局指标将是招募率、保留率和不良事件发生率。将对第3阶段的参与者进行半结构化访谈，以确定参与PR和试验的进一步障碍或促进因素。将采用主题分析法对所有访谈进行解读。
研究结果将为更大规模的多中心RCT的设计提供信息。国家研究伦理服务委员会东米德兰兹分会批准了研究方案。
ISRCTN96143888。
