EPS4.06 safety of exercise as an airway clearance technique to replace chest physiotherapy in people with cystic fibrosis: preliminary insights from the ExACT-CF trial

Saynor, Z., Cunningham, S., Lewis, S., Neilson, A., Ensor, H., Miller, D., Kilarski, E, Bowen, D., Lacey, E., Vogiatzis, I., Allen, L., Soilemezi, D., Taylor, E. and Urquhart, D. (2024) EPS4.06 safety of exercise as an airway clearance technique to replace chest physiotherapy in people with cystic fibrosis: preliminary insights from the ExACT-CF trial. Journal of Cystic Fibrosis, 23 (Suppl. 1), S45. (doi:10.1016/S1569-1993(24)00246-7).

Abstract

Objectives: the ‘Exercise as an Airway Clearance Technique in Cystic Fibrosis (ExACT-CF)’ trial was a 28-day randomised, pilot feasibility trial comparing daily ExACT (stopping all other ACTs) with usual care (chest physiotherapy daily). ExACT-CF was co-designed with the UK CF community. Key secondary aims were to evaluate the safety of asking people with CF (pwCF) to stop all traditional ACT and replace it with ExACT.

Methods: in this two-arm randomised pilot trial conducted at two UK CF centres (Edinburgh and Southampton), 50 pwCF (≥10 years, forced expiratory volume in 1 second [FEV1] >40% predicted; who were stable on Elexacaftor/Tezacaftor/Ivacaftor [ETI]), were recruited and randomly assigned (1:1 allocation using minimisation) to an ExACT programme (stopping all other ACTs) or usual care for 28-days. Safety was assessed by the change in lung clearance index (LCI2.5) over the 28-days, change in FEV1 over the 28-days, exacerbation frequency and the number of recorded adverse events (AEs) and serious AEs (SAEs).

Results: fifty participants (58% male) were recruited across the two centres (mean (standard deviation) age: 20.3 (11.6) years). Forty-eight participants were randomised to either usual care or ExACT. We will present data on changes in lung clearance index (LCI2.5), spirometry (FEV1 and forced vital capacity) from baseline through to 28-days, for both study arms. In addition, we will report rates of AEs and SAEs for each study arm. Qualitative findings also revealed that pwCF involved in the trial felt safe during their 28-day involvement.

Discussion: the ExACT-CF pilot trial is the first multi-centre randomised controlled trial to test the safety of asking pwCF, who are stable on ETI, to stop all traditional chest physiotherapy and replace it with ExACT. These preliminary data will help to inform the design of larger studies of exercise as an ACT in pwCF.

Funding: NIHR Research for Patient Benefit grant (NIHR203185).

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Contributors

Author: Z. Saynor

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