WS08.06 exercise as an airway clearance technique in cystic fibrosis: a pilot randomised controlled trial investigating acceptability and feasibility

Urquhart, D., Taylor, E., Cunningham, S., Lewis, S., Neilson, A., Ensor, H., Miller, D., Kilarski, E., Bowen, D., Lacey, E., Vogiatzis, I., Allen, L., Soilemezi, D., Morrison, L. and Saynor, Z. (2024) WS08.06 exercise as an airway clearance technique in cystic fibrosis: a pilot randomised controlled trial investigating acceptability and feasibility. Journal of Cystic Fibrosis, 23 (Suppl. 1), S16. (doi:10.1016/S1569-1993(24)00157-7).

Abstract

Objectives: to assess the acceptability and feasibility of trial processes in the ‘Exercise as an Airway Clearance Technique in Cystic Fibrosis (ExACT-CF)’ trial, including intervention fidelity assessment.

Methods: ExACT-CF was a multi-centre, two-arm, randomised, pilot trial conducted at two UK sites (Edinburgh and Southampton). Fifty people with CF (pwCF; ≥10 years, forced expiratory volume in 1 second (FEV1) >40% predicted; 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. The primary outcome was the feasibility of recruiting, randomising and retaining 50 pwCF in the ExACT trial; each measured against pre-defined traffic light definitive trial progression criteria. Secondary outcomes included lung function (lung clearance index [LCI2.5] and FEV1), exacerbation questionnaires, physical activity, sleep, treatment burden, mood and quality of life across 28-days, preliminary health-economic data, and embedded qualitative insight.

Results: in total, 370 pwCF were eligible for approach across study sites. Between 17/01/23 and 31/08/2023, 106 were approached, 50 consented and 48 (45% of those approached) were randomised. Of those randomised, 45 (94%) completed all study visits. Further data will be presented at the conference.

Conclusions: we have demonstrated the ability to recruit and retain participants to a trial of exercise replacing chest physiotherapy ACTs. This pilot trial and feedback from the pwCF involved suggests that, with some modification in the design and management, progression to a larger more pragmatic trial is warranted and feasible. This will help optimise the use of exercise within ACT, as well as investigate the wider reaching benefits of structured moderate-to-vigorous intensity aerobic exercise within the management of pwCF.

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

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Contributors

Author: Z. Saynor

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