Title: Improving Outcome Measures For Physiotherapy Trials of Airway Clearance in Adult Cystic Fibrosis
Funder: Health Education England

Abstract: Background:CHAR(13) + CHAR(10) Cystic Fibrosis (CF) is caused by a defective gene causing altered ion and water transport in cells, leading to thick secretions. CF affects over 10,000 people in the UK, with a median predicted survival age of 43 years. Airway clearance techniques (ACTs) to clear secretions are recommended in CF management. To date, research into the effects of ACTs has been criticised due to the lack of a robust and sensitive outcome measure. Recently new measures have been developed which may give a more scientific assessment in terms of amount of change for the effect of an ACT regime. Aims: Through a randomised cross-over trial, we aim to investigate the use of these newly developed assessment tools (electrical impedance tomography, lung clearance index and impulse oscillometry) against the historical gold standard assessment tools of sputum wet weight and FEV1. Comparisons will be made between measures before and after a session of rest, and a session of ACTs to see which assessment tool provides the most reliable, repeatable and valid information in terms of outcome measures for physiotherapy research into airway clearance in adult CF patients. Research Question: Does the use of a new assessment tool box (Electrical Impedance Tomography, Lung Clearance Index, Impulse Oscillometry) give results that are more sensitive to change for the effect of an ACT (the Active Cycle of Breathing Techniques) in stable adult patients with CF than the traditional gold standard outcome measures of FEV1 and sputum wet weight?Plan of Investigation: Adult CF patients in a stable disease state will be invited to complete this study. Participation involves two research visits. Individual's inhalation therapy will be completed as usual. The participant will complete impulse oscillometry and the lung clearance index, spirometry, then for one visit, ACT using ACBT with a specialist CF physiotherapist for a minimum of 30 minutes. The other visit will involve a minimum of 30 minutes rest. During the sessions participants will undergo electrical impedance tomography measurements via a thoracic belt and will collect any expectorated sputum in a special pot that will then be weighed after the session. Immediately after the session the participant will repeat the lung clearance index, impulse oscillometry and spirometry. Summary of Potential Benefits to Patients and the NHS: This research will provide an insight into which outcome measure is the most beneficial to show whether a session of airway clearance completed by an adult with CF has an effect. This will help tailor individual patient ACT regimes by allowing physiotherapists to assess in more depth which of a variety of techniques actually helps the patient clear their sputum the best. Having this reassurance from the physiotherapist should help patients have more confidence in their ACT and positively affect their compliance with ACT. As clearing sputum is known to help prevent pulmonary exacerbations, having more compliant patients with a more effective ACT will have an effect on the wider NHS as it will reduce the treatments required to treat pulmonary exacerbations, including inpatient admissions and antibiotic costs. This research will also have a further effect upon the wider research community, as it will help to guide future studies into ACT as to which outcome measures are best to use, and will allow more scientifically robust research to be completed in the area of respiratory physiotherapy. The results of this study will also be easily translatable into other patient groups with suppurative lung disease and so would have a wider reaching effect both in research and the wider clinical NHS.

Lay abstract: Airway clearance techniques (ACTs) to clear sputum are key to cystic fibrosis (CF) management. There is no consensus as to which ACT is most effective as there is no accepted robust outcome to measure this. This research will compare historical outcome measures (sputum weight and FEV1) against new measures (electrical impedance tomography, lung clearance index, impulse oscillometry) investigating if there is a more scientific measure of ACT effect. This is essential to future scientific research into ACTs. CF patients will benefit from evidence that their daily physiotherapy regimes are effective, and NHS costs will be reduced by more effective regimes.

Research activity codes: 6.7 PHYSICAL;8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: CONGENITAL DISORDERS