Title: A feasibility study to inform the development of a multicentre randomised controlled trial of an asthma-tailored pulmonary rehabilitation programme versus usual care for individuals with severe asthma
Funder: Department of Health (England)

Abstract: Patients with severe asthma have a high morbidity and healthcare cost despite currently available therapies (1;2). Activity limitation is common leading to reduced health related quality of life (HRQoL) (3). Cardio-respiratory fitness (CRF) is a strong predictor of mortality (4) and asthma has a strong inverse association with CRF (5). Despite this, patients with severe asthma are often excluded from exercise schemes due to perceived higher risks (6). Pulmonary Rehabilitation (PR), with core components of exercise training and multi-professional education, is an integral part of the management of patients with chronic lung disease with grade A evidence for improvements in dyspnoea, exercise tolerance and HRQoL (7). International guidance suggests inclusion of patients with asthma, but there is little published evidence evaluating either existing or tailored regimens in severe asthma leading to few patients being referred. Our patients stated a preference for a PR programme specifically for their disease. We propose a feasibility study to inform the study design of a large multi-centre randomised controlled trial (RCT) of asthma-tailored PR (AT-PR) for individuals with severe asthma compared to usual care (UC). The aims of the proposed study are, in patients with severe asthma, to: 1) understand the facilitators and barriers to regular physical activity and exercise 2) understand healthcare professionals' attitudes to exercise for this group 3) perform a small scale version of the eventual RCT to provide information on a) recruitment rate, retention rate, adverse events, accessibility and acceptability of the AT-PR programme, to assess the feasibility of the proposed study protocol, to design and pilot a suitable patient cost questionnaire to be used in the proposed cost effectiveness economic evaluation in the subsequent RCT and b) identify further barriers or facilitators to participation in a AT-PR programme 4) to facilitate patient involvement, in the design, conduct and dissemination, for the multicentre trial Plan of investigation Each stage will involve patients with severe asthma, who remain symptomatic at steps 4 and 5 of the British Thoracic Society asthma guidelines (27), recruited from the Glenfield difficult asthma clinic (DAC). 1) a qualitative study involving semi-structured interviews will explore attitudes to exercise 2) a qualitative study involving focus groups of healthcare professionals’ will explore attitudes to exercise for severe asthma 3) a small scale feasibility study of an RCT of AT-PR versus UC will be performed. A qualitative approach will be used to explore the facilitators and barriers to participation in a AT-PR and the study protocol. AT-PR, modelled on our local successful PR programme for COPD, will be exclusively for severe asthma and further modified according to the findings from stage 1 and 2. Usual care (DAC) will include disease education and exercise advice from asthma nurses. To determine the feasibility of the multi-centre trial, the primary outcomes are recruitment rate, retention rate, and the incidence of adverse events. The outcome measures proposed for the multicentre trial will be included to assess patient acceptability of the tests, study protocol and data completion. They include usual outcome measures for PR (assessed before and after the intervention, and at six months post completion), safety assessments including exercise-induced bronchoconstriction, asthma symptoms, disease activity, healthcare utilisation and cost-effectiveness. 4) the patient involvement during the project will be assessed to make any necessary adaptations for the multicentre trial Potential benefits to patients and the NHS The proposed work will help inform a definitive large RCT of effectiveness of AT-PR that has the potential to provide health benefits for patients with severe asthma nationally. Ultimately, the hypothesis is that the improvement in health status will reduce healthcare utilisation and hence healthcare costs in severe asthma.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: RESPIRATORY