Safety, feasibility and efficacy of exercise as an airway clearance technique in cystic fibrosis - a randomised pilot feasibility trial
Safety, feasibility and efficacy of exercise as an airway clearance technique in cystic fibrosis - a randomised pilot feasibility trial
Objectives: To test the feasibility and safety of exercise as an airway clearance technique (ExACT) for people with cystic fibrosis (pwCF) versus usual care (UC).
Methods: Dual-site, two-arm randomised pilot trial. Fifty pwCF (≥10 years, forced expiratory volume in 1 s (FEV 1) ≥40% predicted), stable on Elexacaftor/ Tezacaftor/Ivacaftor, were recruited, of whom 48 were randomly assigned (1:1 with minimisation) to daily ExACT (stopping all other airway clearance techniques) or UC. Feasibility was measured by recruitment, retention and adherence against preset progression criteria. Key measures of safety and signals of efficacy included spirometry (FEV 1), lung clearance index (LCI 2.5), pulmonary exacerbations, physical activity, treatment burden and quality of life across 28 days. Qualitative interview data and preliminary health economic data were also collected.
Findings: ExACT was safe over 28 days, measured by change in LCI 2.5 (ExACT −0.1 (0.6) vs UC 0.2 (0.8), mean (SD)) and FEV 1 (ExACT +2.1 (6.6) vs UC −0.8 (5.5), % predicted mean (SD)). Relative (ExACT/UC) differences of 0.97 (0.92, 1.02) for LCI 2.5 and absolute differences (ExACT-UC) of 3.2 (−0.6, 6.9) % predicted for FEV 1 suggest potential intervention efficacy. Few adverse events were reported; none serious. Recruitment and retention data suggest progression to a definitive trial, with 48/117 (41% of approached) randomised, 45/48 (92%) completing the study and a 60% overall adherence rate.
Discussion: Testing of our primary hypothesis within a feasibility trial showed ExACT to be a safe, acceptable and feasible intervention for pwCF. These data support advancement to a definitive, longer-term, multisite trial evaluating the safety, efficacy and cost-effectiveness of ExACT, following minor refinement.
Urquhart, Don S.
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Taylor, Emily
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Cunningham, Steve
ec9ed02f-4643-4289-bb1a-ea57b4a10d75
Lewis, Steff
c5e09388-86d0-419c-b94a-f998e67d79f3
Neilson, Aileen Rae
8a59e279-d374-42fa-8cd3-cca39222c6dc
Soilemezi, Dia
e6103835-8435-455a-8340-a4974580a7c4
Ensor, Hannah
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Vogiatzis, Ioannis
f68615c4-ca3f-4679-a39e-ec80087e5af7
Allen, Lorna
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Saynor, Zoe L.
a4357c7d-db59-4fa5-b24f-58d2f7e74e39
Urquhart, Don S.
e9d0122a-01b2-477e-9e5c-3b23b247ca5e
Taylor, Emily
1d0fc329-8251-4ac3-b13c-8ef0048eadd0
Cunningham, Steve
ec9ed02f-4643-4289-bb1a-ea57b4a10d75
Lewis, Steff
c5e09388-86d0-419c-b94a-f998e67d79f3
Neilson, Aileen Rae
8a59e279-d374-42fa-8cd3-cca39222c6dc
Soilemezi, Dia
e6103835-8435-455a-8340-a4974580a7c4
Ensor, Hannah
6b7c3a79-2225-48ea-8586-f7fbab8ea643
Vogiatzis, Ioannis
f68615c4-ca3f-4679-a39e-ec80087e5af7
Allen, Lorna
4d1c0e92-288f-4a8f-b1a4-e244ac4e8b07
Saynor, Zoe L.
a4357c7d-db59-4fa5-b24f-58d2f7e74e39
Urquhart, Don S., Taylor, Emily, Cunningham, Steve, Lewis, Steff, Neilson, Aileen Rae, Soilemezi, Dia, Ensor, Hannah, Vogiatzis, Ioannis, Allen, Lorna and Saynor, Zoe L.
,
the ExACT-CF study group
(2025)
Safety, feasibility and efficacy of exercise as an airway clearance technique in cystic fibrosis - a randomised pilot feasibility trial.
Thorax, [223080].
(doi:10.1136/thorax-2025-223080).
(In Press)
Abstract
Objectives: To test the feasibility and safety of exercise as an airway clearance technique (ExACT) for people with cystic fibrosis (pwCF) versus usual care (UC).
Methods: Dual-site, two-arm randomised pilot trial. Fifty pwCF (≥10 years, forced expiratory volume in 1 s (FEV 1) ≥40% predicted), stable on Elexacaftor/ Tezacaftor/Ivacaftor, were recruited, of whom 48 were randomly assigned (1:1 with minimisation) to daily ExACT (stopping all other airway clearance techniques) or UC. Feasibility was measured by recruitment, retention and adherence against preset progression criteria. Key measures of safety and signals of efficacy included spirometry (FEV 1), lung clearance index (LCI 2.5), pulmonary exacerbations, physical activity, treatment burden and quality of life across 28 days. Qualitative interview data and preliminary health economic data were also collected.
Findings: ExACT was safe over 28 days, measured by change in LCI 2.5 (ExACT −0.1 (0.6) vs UC 0.2 (0.8), mean (SD)) and FEV 1 (ExACT +2.1 (6.6) vs UC −0.8 (5.5), % predicted mean (SD)). Relative (ExACT/UC) differences of 0.97 (0.92, 1.02) for LCI 2.5 and absolute differences (ExACT-UC) of 3.2 (−0.6, 6.9) % predicted for FEV 1 suggest potential intervention efficacy. Few adverse events were reported; none serious. Recruitment and retention data suggest progression to a definitive trial, with 48/117 (41% of approached) randomised, 45/48 (92%) completing the study and a 60% overall adherence rate.
Discussion: Testing of our primary hypothesis within a feasibility trial showed ExACT to be a safe, acceptable and feasible intervention for pwCF. These data support advancement to a definitive, longer-term, multisite trial evaluating the safety, efficacy and cost-effectiveness of ExACT, following minor refinement.
More information
Accepted/In Press date: 15 August 2025
Identifiers
Local EPrints ID: 504010
URI: http://eprints.soton.ac.uk/id/eprint/504010
ISSN: 0040-6376
PURE UUID: 26d189d4-1bf3-4740-876b-a44125737550
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Date deposited: 21 Aug 2025 06:50
Last modified: 25 Nov 2025 03:16
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Contributors
Author:
Don S. Urquhart
Author:
Emily Taylor
Author:
Steve Cunningham
Author:
Steff Lewis
Author:
Aileen Rae Neilson
Author:
Dia Soilemezi
Author:
Hannah Ensor
Author:
Ioannis Vogiatzis
Author:
Lorna Allen
Author:
Zoe L. Saynor
Corporate Author: the ExACT-CF study group
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