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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, FEV1 ≥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 pre-set progression criteria. Key measures of safety and for signals of efficacy included spirometry (FEV1), lung clearance index (LCI2.5), 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 LCI2.5 (ExACT -0.1 (0.6) vs. UC 0.2 (0.8) mean (SD)) and FEV1 (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 LCI2.5 and absolute differences (ExACT-UC) of 3.2 (-0.6, 6.9) % predicted for FEV1 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, multi-site trial evaluating the safety, efficacy, and cost-effectiveness of ExACT, following minor refinement.
Methods: Dual-site, two-arm, randomised pilot trial. Fifty pwCF (≥10 years, FEV1 ≥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 pre-set progression criteria. Key measures of safety and for signals of efficacy included spirometry (FEV1), lung clearance index (LCI2.5), 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 LCI2.5 (ExACT -0.1 (0.6) vs. UC 0.2 (0.8) mean (SD)) and FEV1 (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 LCI2.5 and absolute differences (ExACT-UC) of 3.2 (-0.6, 6.9) % predicted for FEV1 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, multi-site trial evaluating the safety, efficacy, and cost-effectiveness of ExACT, following minor refinement.
| Original language | English |
|---|---|
| Journal | Thorax |
| DOIs | |
| Publication status | Published - 1 Oct 2025 |
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Dive into the research topics of 'Safety, feasibility and efficacy of exercise as an airway clearance technique in cystic fibrosis – a randomized pilot feasibility trial'. Together they form a unique fingerprint.Projects
- 1 Finished
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ExACT-CF: Exercise as an Airway Clearance Technique in people with Cystic Fibrosis – A Randomised Pilot Trial
Urquhart, D. (Principal Investigator), Cunningham, S. (Co-investigator) & Lewis, S. (Co-investigator)
University Hospital Southampton NHS Foundation Trust
1/05/22 → 2/04/24
Project: Research