Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2016-09-30
2021-12-31
Brief Summary
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Each participant will attend the research facility for two visits. Participants will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult CF.
Participants will perform the outcome measure (OM) tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be completed at the end of each study visit.
Analysis will be based upon differences in outcome measures and in-between study days.
Detailed Description
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Hypothesis: The use of a new outcome assessment tool box will allow more sensitive information about the effects of ACTs in stable adult patients with CF than the current gold standard measures.
This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London. Participants will be their own controls. Each participant will attend the research facility for two visits. Prior to starting the study assessment session participants will be questioned to ensure they are in a stable state of their disease (characterised by symptoms and having had no treatment changes for 28 days prior to the visit). All participants will continue with the timing and prescribed dosing of all inhaled medications as directed prior to the study. Subjects will be their own controls. Subjects will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising the Active Cycle of Breathing Techniques (ACBT) supervised by a specialist physiotherapist in adult CF. The ACT session will last for thirty minutes minimum, to 60 minutes maximum until a consensus is reached between participant and physiotherapist that the participant's chest is clear.
Subjects will perform the OM tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated immediately after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be given for completion after the last OM test is completed on each study visit.
There are no planned follow up measurements for participants in this study design.
All usual medications will be permitted for this study. Attention will be paid to mucoactive drugs (Pulmozyme®, Mannitol®, Hypertonic saline) to ensure the same frequency and dosing of inhalations for both study visits.
Data will be analysed in 3 groups based upon disease severity. Analysis will be based upon differences in outcome measures and in-between study days.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Visit A
Rest period for 30-60 minutes
Rest period
A 30-60 minute of resting
Visit B
Airway clearance session utilising the Active Cycle of Breathing techniques (ACBT) supervised by a specialist physiotherapist for 30-60 minutes.
Airway clearance session using the Active Cycle of Breathing Techniques (ACBT)
An airway clearance technique incorporating thoracic expansion exercises, breathing control (normal diaphragmatic breathing) and the forced expiration technique (or huffing)
Interventions
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Airway clearance session using the Active Cycle of Breathing Techniques (ACBT)
An airway clearance technique incorporating thoracic expansion exercises, breathing control (normal diaphragmatic breathing) and the forced expiration technique (or huffing)
Rest period
A 30-60 minute of resting
Eligibility Criteria
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Inclusion Criteria
* Sixteen years of age or over
* Patients in a stable state (characterised by no required therapy changes within 28 days of visit and patient symptoms)
Exclusion Criteria
* Current moderate haemoptysis (greater than streaking in the sputum)
* Current dependency on positive pressure support with ACT
* Previous history of spontaneous rib fractures
* Pregnancy
* Inability to give consent for treatment or measurement
* Current participation in another interventional study
* Current dependency upon non-invasive ventilation
* Current dependency upon oxygen therapy
16 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Nicholas J Simmonds, MD(Res) FRCP
Role: PRINCIPAL_INVESTIGATOR
The Royal Brompton & Harefield NHS Foundation Trust and Imperial College, London
Locations
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The Royal Brompton Hospital
London, Greater London, United Kingdom
Countries
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References
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Kent L, Reix P, Innes JA, Zielen S, Le Bourgeois M, Braggion C, Lever S, Arets HG, Brownlee K, Bradley JM, Bayfield K, O'Neill K, Savi D, Bilton D, Lindblad A, Davies JC, Sermet I, De Boeck K; European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN) Standardisation Committee. Lung clearance index: evidence for use in clinical trials in cystic fibrosis. J Cyst Fibros. 2014 Mar;13(2):123-38. doi: 10.1016/j.jcf.2013.09.005. Epub 2013 Dec 5.
Bradley JM, Moran FM, Elborn JS. Evidence for physical therapies (airway clearance and physical training) in cystic fibrosis: an overview of five Cochrane systematic reviews. Respir Med. 2006 Feb;100(2):191-201. doi: 10.1016/j.rmed.2005.11.028.
Osman LP, Roughton M, Hodson ME, Pryor JA. Short-term comparative study of high frequency chest wall oscillation and European airway clearance techniques in patients with cystic fibrosis. Thorax. 2010 Mar;65(3):196-200. doi: 10.1136/thx.2008.111492. Epub 2009 Aug 23.
Pfleger A, Steinbacher M, Schwantzer G, Weinhandl E, Wagner M, Eber E. Short-term effects of physiotherapy on ventilation inhomogeneity in cystic fibrosis patients with a wide range of lung disease severity. J Cyst Fibros. 2015 Sep;14(5):627-31. doi: 10.1016/j.jcf.2014.12.017. Epub 2015 Jan 19.
Wettstein M, Radlinger L, Riedel T. Effect of different breathing aids on ventilation distribution in adults with cystic fibrosis. PLoS One. 2014 Sep 15;9(9):e106591. doi: 10.1371/journal.pone.0106591. eCollection 2014.
Horsley A. 2009. 'Non-Invasive Assessment of Ventilation Maldistribution in Lung Disease Using Multiple Breath Inert Gas Washouts', University of Edinburgh, UK
Hurt, K. 2013. 'Small Airways Assessment In Adult Cystic Fibrosis', Imperial College (National Heart and Lung Institute), UK
Stanford G, Davies JC, Usmani O, Banya W, Charman S, Jones M, Simmonds NJ, Bilton D. Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial. BMJ Open Respir Res. 2020 Oct;7(1):e000694. doi: 10.1136/bmjresp-2020-000694.
Other Identifiers
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2016CF001B
Identifier Type: -
Identifier Source: org_study_id