Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in wards for older people

Background: falls disproportionately affect older people, who are at increased risk of falls and injury. This pilot study investigates shock-absorbing flooring for fall-related injuries in wards for frail older people.Methods: we conducted a non-blinded cluster randomised trial in eight hospitals in England between April 2010 and August 2011. Each site allocated one bay as the ‘study area’, which was randomised via computer to intervention (8.3-mm thick Tarkett Omnisports EXCEL) or control (2-mm standard in situ flooring). Sites had an intervention period of 1 year. Anybody admitted to the study area was eligible. The primary outcome was the fall-related injury rate. Secondary outcomes were injury severity, fall rate and adverse events.Results: during the intervention period, 226 participants were recruited to each group (219 and 223 were analysed in the intervention and control group, respectively). Of 35 falls (31 fallers) in the intervention group, 22.9% were injurious, compared with 42.4% of 33 falls (22 fallers) in the control group [injury incident rate ratio (IRR) = 0.58, 95% CI = 0.18–1.91]. There were no moderate or major injuries in the intervention group and six in the control group. The fall IRR was 1.07 (95% CI = 0.64–1.81). Staff at intervention sites raised concerns about pushing equipment, documenting one pulled back.Conclusions: future research should assess shock-absorbing flooring with better ‘push/pull’ properties and explore increased faller risk. We estimate a future trial will need 33,480–52,840 person bed-days per arm.Trial registration: ClinicalTrials.gov (ID: NCT00817869); UKCRN (ID: 5735)

A922 Sequential measurement of 1 hour creatinine clearance (1-CRCL) in critically ill patients at risk of acute kidney injury (AKI)

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P455 experiences of participants and staff involved in the Exercise as an Airway Clearance Technique in people with Cystic Fibrosis pilot feasibility trial: preliminary findings from a qualitative study

Background: we conducted qualitative interviews as part of the ‘Exercise as an Airway Clearance Technique in Cystic Fibrosis (ExACT-CF)’, mixed methods pilot randomised controlled trial, to understand experiences and acceptability of various trial processes in participants, parents and trial staff.Methods: purposive sampling ensured participants and relevant professionals represented all recruiting sites. A total of 32 semi-structured telephone/ online interviews were carried out including 10 people with CF (pwCF), 5 parents (7 ExACT; 8 Usual Care), 12 trial staff, 4 decliners and 1 drop-out. Interviews were recorded, transcribed verbatim and analysed adopting a Framework Approach.Results: our preliminary analysis revealed three main themes : 1) facilitators, 2) barriers and 3) future suggestions, to capture individuals experiences of the trial processes including; recruitment and randomisation (e.g. willingness to help, reluctance to be randomised, travel time), experiences of the intervention and its effects (e.g. wide variety of exercises, enjoyment, challenges with exercising daily, increasing support with starting and progressing exercise) and usability of the various outcome measures (e.g. most preferred, practicality). Looking forward, there was overwhelming support for an interchange model (ExACT and other chest physiotherapy ACTs), which would enable flexibility (e.g. around busy lifestyles, exacerbations) and the importance of choice in interventions for pwCF was emphasised.Conclusions: participants spoke favourably about their experience in the ExACT-CF trial, which was not perceived as too onerous. ExACT alone or in combination with chest physiotherapy was regarded as a positive, enjoyable and acceptable intervention. Our findings confirm the acceptability of the trial processes and intervention, whilst also identifying important areas for modification to enhance a definitive future trial.Funding: NIHR Research for Patient Benefit grant (NIHR203185)

P166 utility of lung clearance index (LCI_2.5) as an outcome measure in cystic fibrosis clinical trials – perspectives of people with cystic fibrosis and LCI_2.5 operators

Objectives: we explored the perspectives of people with cystic fibrosis (pwCF) and multiple breath washout (MBW) operators regarding the use of LCI2.5 in the ‘Exercise as an Airway Clearance Technique in CF (ExACT-CF)’ trial.Methods: LCI2.5 was measured at baseline and 28-days by nitrogen-multiple breathwashout (N2-MBW; Exhalyzer-D, EcoMedics, Switzerland), with training and over-reading support provided by the ECFS-CTN LCI Core Facility and the UK CF Trust Clinical Trials Accelerator Platform (London). A subsample of participants, parents and trial staff also undertook semi-structured interviews regarding their trial experiences, including outcome measures. Participants were also invited to complete a short bespoke questionnaire focused on ease and comfort of performing N2-MBW, perceptions regarding time to do the test, and their willingness to perform N2-MBW in the future; using a Likert (1–5) scale. Free-text comments were also analysed. Qualitative interview transcripts were thematically analysed using a Framework Approach and any outcomes relating to N2-MBW collated.Results: of 50 participants recruited into the trial, MBWwas performed in 49. Of the 15 questionnaire respondents (6 paediatric, 9 adults), 86.7% ranked the test as easy or very easy to perform, 93.3% ranked it comfortable or very comfortable, and 86.7% would be willing to perform the test again. Further qualitative insight into the use of LCI2.5 will be presented at the conference.Discussion: questionnaire responses and qualitative data frompwCF in the ExACT-CF study suggest that N2-MBW is easy to perform, comfortable to do, and is a test that pwCF across a range of ages and disease severities would be willing to do again. Study participants did not perceive an excessive time burden with N2-MBW and qualitative and questionnaire information supports the ease of performing the test; however the low sample size is acknowledged.Funding: NIHR Research for Patient Benefit grant (NIHR203185)

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

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)

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

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)

P164 Utility of LCI2.5 as an outcome measure for people with cystic fibrosis of all ages – Experience from a pilot feasibility trial spanning adult and paediatric care

Lung clearance index (LCI2.5), measured by nitrogen-multiple breath washout (N2-MBW), is a measure of ventilation inhomogeneity and a promising endpoint for clinical trials in cystic fibrosis (CF). The utility of LCI2.5 in adult lung disease has been questioned, due to long test times. LCI2.5 was included as a key safety outcome in the ‘Exercise as an Airway Clearance Technique in CF (ExACT-CF)’ study – a randomised, pilot feasibility trial comparing daily ExACT with usual care (chest physiotherapy). We report utility of LCI2.5 as an outcome measure in this 28-day trial which spanned adult and paediatric age groups