Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/25580
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dc.contributor.authorHolland, Anne E-
dc.contributor.authorCorte, Tamera-
dc.contributor.authorChambers, Daniel C-
dc.contributor.authorPalmer, Andrew J-
dc.contributor.authorEkström, Magnus Per-
dc.contributor.authorGlaspole, Ian-
dc.contributor.authorGoh, Nicole S L-
dc.contributor.authorHepworth, Graham-
dc.contributor.authorKhor, Yet H-
dc.contributor.authorHoffman, Mariana-
dc.contributor.authorVlahos, Ross-
dc.contributor.authorSköld, Magnus-
dc.contributor.authorDowman, Leona M-
dc.contributor.authorTroy, Lauren K-
dc.contributor.authorPrasad, Jyotika D-
dc.contributor.authorWalsh, James-
dc.contributor.authorMcDonald, Christine F-
dc.date2020-12-13-
dc.date.accessioned2021-01-04T23:56:41Z-
dc.date.available2021-01-04T23:56:41Z-
dc.date.issued2020-12-13-
dc.identifier.citationBMJ Open 2020; 10(12): e040798en
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/25580-
dc.description.abstractInterstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation. A randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen concentrator (POC) during daily activities and control participants will use an identical POC modified to deliver air. Outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is change in physical activity measured by number of steps per day using a physical activity monitor (StepWatch). Secondary outcomes are functional capacity (6-minute walk distance), health-related quality of life (St George Respiratory Questionnaire, EQ-5D-5L and King's Brief Interstitial Lung Disease Questionnaire), breathlessness (Dyspnoea-12), fatigue (Fatigue Severity Scale), anxiety and depression (Hospital Anxiety and Depression Scale), physical activity level (GENEActive), oxygen saturation in daily life, POC usage, and plasma markers of skeletal muscle metabolism, systematic inflammation and oxidative stress. A cost-effectiveness evaluation will also be undertaken. Ethical approval has been granted in Australia by Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/42) with governance approval at all Australian sites, and in Sweden (Lund Dnr: 2019-02963). The results will be published in peer-reviewed scientific journals, presented at conferences and disseminated to consumers in publications for lay audiences. ClinicalTrials.gov Registry (NCT03737409).en
dc.language.isoeng-
dc.subjectclinical trialsen
dc.subjectinterstitial lung diseaseen
dc.subjectthoracic medicineen
dc.titleAmbulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial.en
dc.typeJournal Articleen
dc.identifier.journaltitleBMJ openen
dc.identifier.affiliationDepartment of Respiratory Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australiaen
dc.identifier.affiliationDepartment of Physiotherapy, Alfred Health, Melbourne, Victoria, Australiaen
dc.identifier.affiliationCentre for Health Policy, School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australiaen
dc.identifier.affiliationDepartment of Allergy, Immunology and Respiratory Medicine, Monash University, Melbourne, Victoria, Australiaen
dc.identifier.affiliationSchool of Clinical Medicine, The University of Queensland, Brisbane, Queensland, Australiaen
dc.identifier.affiliationQueensland Lung Transplant Service, The Prince Charles Hospital, Brisbane, Queensland, Australiaen
dc.identifier.affiliationFaculty of Medicine, University of Melbourne, Melbourne, Victoria, Australiaen
dc.identifier.affiliationNHMRC Centre of Research Excellence in Pulmonary Fibrosis, Camperdown, New South Wales, Australiaen
dc.identifier.affiliationDepartment of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australiaen
dc.identifier.affiliationCentral Clinical School, The University of Sydney, Sydney, New South Wales, Australiaen
dc.identifier.affiliationInstitute for Breathing and Sleepen
dc.identifier.affiliationPhysiotherapy Department, The Prince Charles Hospital, Brisbane, Queensland, Australiaen
dc.identifier.affiliationDepartment of Allergy, Immunology and Respiratory Medicine, Monash University, Melbourne, Victoria, Australiaen
dc.identifier.affiliationRespiratory and Sleep Medicineen
dc.identifier.affiliationPhysiotherapyen
dc.identifier.affiliationSchool of Health and Biomedical Sciences, RMIT University, Bundoora, Melbourne, Australiaen
dc.identifier.affiliationRespiratory Medicine Unit, Department of Medicine Solna and Center for Molecular Medicine, Karolinska Institutet, Stockholm, Swedenen
dc.identifier.affiliationDepartment of Respiratory Medicine and Allergy, Karolinska University Hospital, Stockholm, Swedenen
dc.identifier.affiliationStatistical Consulting Centre, University of Melbourne, Melbourne, Victoria, Australiaen
dc.identifier.affiliationDepartment of Respiratory and Sleep Medicine, Alfred Health, Melbourne, Victoria, Australiaen
dc.identifier.affiliationHealth Economics Research Group, Menzies Institute for Medical Research, The University of Tasmania, Hobart, Tasmania, Australiaen
dc.identifier.affiliationRespiratory Medicine and Allergology, Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Swedenen
dc.identifier.doi10.1136/bmjopen-2020-040798en
dc.type.contentTexten
dc.identifier.orcid0000-0003-2061-845Xen
dc.identifier.pubmedid33318119-
local.name.researcherDowman, Leona M
item.languageiso639-1en-
item.openairetypeJournal Article-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.cerifentitytypePublications-
crisitem.author.deptInstitute for Breathing and Sleep-
crisitem.author.deptPhysiotherapy-
crisitem.author.deptRespiratory and Sleep Medicine-
crisitem.author.deptInstitute for Breathing and Sleep-
crisitem.author.deptRespiratory and Sleep Medicine-
crisitem.author.deptInstitute for Breathing and Sleep-
crisitem.author.deptMedicine (University of Melbourne)-
crisitem.author.deptPhysiotherapy-
crisitem.author.deptInstitute for Breathing and Sleep-
crisitem.author.deptInstitute for Breathing and Sleep-
crisitem.author.deptRespiratory and Sleep Medicine-
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