Protocol for a feasibility study to inform the development of a multicentre randomised controlled trial of asthma-tailored pulmonary rehabilitation versus usual care for individuals with severe asthma Sally Majd, 1,2,3 Lindsay D Apps, 1,2 Nicky Hudson, 4 Stacey Hewitt, 1,2 Elizabeth Eglinton, 5 Anna Murphy, 2,6,7 Peter Bradding, 2,3,6 Sally Singh, 1,2,3,6 Ruth Green, 2,3,6 Rachael Evans 1,2,3,6 To cite: Majd S, Apps LD, Hudson N, et al. Protocol for a feasibility study to inform the development of a multicentre randomised controlled trial of asthma-tailored pulmonary rehabilitation versus usual care for individuals with severe asthma. BMJ Open 2016;6:e010574. doi:10.1136/bmjopen-2015- 010574 ▸ Prepublication history for this paper is available online. To view these files please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2015-010574). Received 16 November 2015 Revised 20 December 2015 Accepted 23 December 2015 For numbered affiliations see end of article. Correspondence to Dr Sally Majd; sally.majd@uhl-tr.nhs.uk ABSTRACT Introduction: 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. Methods and analysis: 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. Ethics and dissemination: The study results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee East Midland approved the study protocol. Trial registration number: ISRCTN96143888. INTRODUCTION The most recent global estimate of asthma suggests that up to 334 million people suffer from asthma with a high burden of disability 1 that is estimated to be greater than for both diabetes and breast cancer. 2 Much of this dis- ability is in the 10–20% of patients with severe disease despite currently available therapies 3 4 who consume 50–60% of the healthcare costs attributed to asthma. 56 This reflects a considerable unmet need for this population, and represents a major eco- nomic burden. Novel approaches to treat- ment are therefore needed urgently. Cardiorespiratory fitness is a strong pre- dictor of mortality in both health and disease. 7 Improving cardiorespiratory fitness Strengths and limitations of this study ▪ This study focuses on the feasibility of a planned multicentre randomised controlled trial of asthma-tailored pulmonary rehabilitation versus usual care for severe asthma. ▪ The intervention will be tailored using informa- tion from qualitative studies regarding the views around exercise and exercise programmes of both patients with severe asthma and healthcare professionals involved in their care. ▪ The success of the study will depend on devel- oping appropriate recruitment strategies. Majd S, et al. BMJ Open 2016;6:e010574. doi:10.1136/bmjopen-2015-010574 1 Open Access Protocol