Exercise as an Airway Clearance Technique in people with Cystic Fibrosis (ExACT-CF): rationale and study protocol for a randomised pilot trial [version 1; peer review: awaiting peer review]

Urquhart, Don S., Cunningham, Steve, Taylor, Emily, Vogiatzis, Ioannis, Allen, Lorna, Lewis, Steff, Neilson, Aileen R., Soilemezi, Dia, Akooji, Naseerah and Saynor, Zoe L. (2022) Exercise as an Airway Clearance Technique in people with Cystic Fibrosis (ExACT-CF): rationale and study protocol for a randomised pilot trial [version 1; peer review: awaiting peer review]. NIHR Open Research, 2. p. 64. ISSN 2633-4402 (In Press)

af18348a-cab7-4dcc-99b4-be15c1c2282c_13347_-_zoe_saynor.pdf - Published Version

Download (1MB) | Preview
Official URL: https://doi.org/10.3310/nihropenres.13347.1


Background: Chest physiotherapy is an established cornerstone of care for people with cystic fibrosis (pwCF), but is often burdensome. Guidelines recommend at least one chest physiotherapy session daily, using various airway clearance techniques (ACTs). Exercise (with huffs and coughs) may offer an alternative ACT, however the willingness of pwCF to be randomised into a trial needs testing. The ‘ExACT-CF: Exercise as an Airway Clearance Technique in people with Cystic Fibrosis’ trial will test the feasibility of recruiting pwCF to be randomised to continue usual care (chest physiotherapy) or replace it with exercise ACT (ExACT) for 28-days. Secondary aims include determining the short-term clinical impact (and safety) of stopping routine chest physiotherapy and replacing it with ExACT, and effects on physical activity, sleep, mood, quality of life and treatment burden, alongside preliminary health economic measures and acceptability.
Methods: Multi-centre, two-arm, randomised (1:1 allocation using minimisation), pilot trial at two sites. Fifty pwCF (≥10 years, FEV1 >40% predicted, stable on Elexacaftor/Tezacaftor/Ivacaftor (ETI)) will be randomised to an individually-customised ExACT programme (≥once daily aerobic exercise of ≥20-minutes duration at an intensity that elicits deep breathing, with huffs and coughs), or usual care. After baseline assessments, secondary outcomes will be assessed after 28-days, with additional home lung function and exacerbation questionnaires at 7, 14 and 21-days, physical activity and sleep monitoring throughout, and embedded qualitative and health-economic components. Feasibility measures include recruitment, retention, measurement completion, adverse events, interviews exploring the acceptability of trial procedures, and a trial satisfaction questionnaire.
Discussion: Co-designed with the UK CF community, the ExACT-CF pilot trial is the first multi-centre RCT to test the feasibility of recruiting pwCF stable on ETI into a trial investigating ExACT. This pilot trial will inform the feasibility, design, management, likely external validity for progression to a main phase randomised controlled trial.
Registration: Clinicaltrials.gov (NCT05482048).

Item Type: Article
Additional Information: Copyright: © Crown copyright, 2022 Urquhart DS et al. This open access work is licensed under the Open Government Licence v3.0 Open Government Licence Funding information: This project is funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR203185). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Uncontrolled Keywords: airway clearance therapy, cystic fibrosis, exercise, feasibility, physical activity, physiotherapy, randomised controlled trial
Subjects: B100 Anatomy, Physiology and Pathology
B900 Others in Subjects allied to Medicine
C600 Sports Science
Department: Faculties > Health and Life Sciences > Sport, Exercise and Rehabilitation
Depositing User: Elena Carlaw
Date Deposited: 06 Jan 2023 13:05
Last Modified: 06 Jan 2023 13:22
URI: https://nrl.northumbria.ac.uk/id/eprint/51071

Actions (login required)

View Item View Item


Downloads per month over past year

View more statistics