title: A randomised controlled trial of supplemental oxygen versus medical air during exercise training in people with chronic obstructive pulmonary disease: supplemental oxygen in pulmonary rehabilitation trial (SuppORT) (Protocol).
abstract: BACKGROUND
  Oxygen desaturation during exercise is common in people with chronic obstructive pulmonary disease (COPD). The aim of the study is to determine, in people with COPD who desaturate during exercise, whether supplemental oxygen during an eight-week exercise training program is more effective than medical air (sham intervention) in improving exercise capacity and health-related quality of life both at the completion of training and at six-month follow up.
  
  
  METHODS
  This is a multi-centre randomised controlled trial with concealed allocation, blinding of participants, exercise trainers and assessors, and intention-to-treat analysis. 110 people with chronic obstructive pulmonary disease who demonstrate oxygen desaturation lower than 90 % during the six-minute walk test will be recruited from pulmonary rehabilitation programs in seven teaching hospitals in Australia. People with chronic obstructive pulmonary disease on long term oxygen therapy will be excluded. After confirmation of eligibility and baseline assessment, participants will be randomised to receive either supplemental oxygen or medical air during an eight-week supervised treadmill and cycle exercise training program, three times per week for eight weeks, in hospital outpatient settings. Primary outcome measures will be endurance walking capacity assessed by the endurance shuttle walk test and health-related quality of life assessed by the Chronic Respiratory Disease Questionnaire. Secondary outcomes will include peak walking capacity measured by the incremental shuttle walk test, dyspnoea via the Dyspnoea-12 questionnaire and physical activity levels measured over seven days using an activity monitor. All outcomes will be measured at baseline, completion of training and at six-month follow up.
  
  
  CONCLUSIONS
  Exercise training is an essential component of pulmonary rehabilitation for people with COPD. This study will determine whether supplemental oxygen during exercise training is more effective than medical air in improving exercise capacity and health-related quality of life in people with COPD who desaturate during exercise.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ACTRN12612000395831, 5th Jan,2012.
authors: Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia. jennifer.alison@sydney.edu.au.|Department of Physiotherapy, Royal Prince Alfred Hospital, Sydney, Australia. jennifer.alison@sydney.edu.au.
authors: Jennifer A
authors: JA
authors: Alison
authors: Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia. zoe.mckeough@sydney.edu.au.
authors: Zoe J
authors: ZJ
authors: McKeough
authors: Institute for Respiratory Health, Perth, Australia. S.Jenkins@curtin.edu.au.|Department of Physiotherapy, Sir Charles Gairdner Hospital, Perth, Australia. S.Jenkins@curtin.edu.au.|School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Perth, Australia. S.Jenkins@curtin.edu.au.
authors: Sue C
authors: SC
authors: Jenkins
authors: Discipline of Physiotherapy, School of Allied Health, La Trobe University, Melbourne, Australia. a.holland@alfred.org.au.|Department of Physiotherapy, Alfred Health, Melbourne, Australia. a.holland@alfred.org.au.|Institute for Breathing and Sleep, Melbourne, Australia. a.holland@alfred.org.au.
authors: Anne E
authors: AE
authors: Holland
authors: Institute for Respiratory Health, Perth, Australia. k.hill@curtin.edu.au.|School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Perth, Australia. k.hill@curtin.edu.au.
authors: Kylie
authors: K
authors: Hill
authors: Menzies Health Institute and School of Allied Health Sciences, Griffith University, Brisbane, Australia. m.morris@griffiths.edu.au.|The Queensland Lung Transplant Service, The Prince Charles Hospital, Brisbane, Australia. m.morris@griffiths.edu.au.
authors: Norman R
authors: NR
authors: Morris
authors: Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia. regina.leung@sydney.edu.au.|Department of Respiratory and Sleep Medicine, Concord Repatriation General Hospital, Sydney, Australia. regina.leung@sydney.edu.au.
authors: Regina W M
authors: RW
authors: Leung
authors: Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia. kwil4851@uni.sydney.edu.au.
authors: Kathleen A
authors: KA
authors: Williamson
authors: Department of Physiotherapy, Royal Prince Alfred Hospital, Sydney, Australia. lissa.spencer@sswahs.nsw.gov.au.
authors: Lissa M
authors: LM
authors: Spencer
authors: Institute for Breathing and Sleep, Melbourne, Australia. catherine.hill@austin.org.au.|Department of Physiotherapy, Austin Health, Melbourne, Australia. catherine.hill@austin.org.au.
authors: Catherine J
authors: CJ
authors: Hill
authors: Department of Physiotherapy, Alfred Health, Melbourne, Australia. Annemarie.Lee@westpark.org.|Institute for Breathing and Sleep, Melbourne, Australia. Annemarie.Lee@westpark.org.
authors: Annemarie L
authors: AL
authors: Lee
authors: The Queensland Lung Transplant Service, The Prince Charles Hospital, Brisbane, Australia. helen_seale@health.qld.gov.au.
authors: Helen
authors: H
authors: Seale
authors: Department of Physiotherapy, Sir Charles Gairdner Hospital, Perth, Australia. Nola.cecins@health.wa.gov.au.
authors: Nola
authors: N
authors: Cecins
authors: Institute for Breathing and Sleep, Melbourne, Australia. Christine.mcDonald@austin.org.au.|Department of Respiratory and Sleep Medicine, Austin Health, Melbourne, Australia. Christine.mcDonald@austin.org.au.|Department of Medicine, The University of Melbourne, Melbourne, Australia. Christine.mcDonald@austin.org.au.
authors: Christine F
authors: CF
authors: McDonald
mesh_terms: D001315:Australia; D004311:Double-Blind Method; D004417:Dyspnea / Q000503:physiopathology; D005080:Exercise Test; D005081:Exercise Therapy / Q000379:methods*; D017079:Exercise Tolerance / Q000502:physiology; D005541:Forced Expiratory Volume; D006304:Health Status; D006801:Humans; D057194:Intention to Treat Analysis; D010092:Oximetry; D010102:Oxygen Inhalation Therapy / Q000379:methods*; D029424:Pulmonary Disease, Chronic Obstructive / Q000503:physiopathology / Q000534:rehabilitation*; D011788:Quality of Life; D016896:Treatment Outcome; D014797:Vital Capacity