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Trial registered on ANZCTR
Registration number
ACTRN12612000395831
Ethics application status
Approved
Date submitted
4/04/2012
Date registered
5/04/2012
Date last updated
11/10/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised controlled trial of supplemental oxygen versus medical air in people with chronic obstructive pulmonary disease: Supplemental Oxygen in Pulmonary Rehabilitation Trial (SuppORT)
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Scientific title
The effect of supplemental oxygen or medical air during exercise training on exercise capacity and quality of life in people with chronic obstructive pulmonary disease
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Secondary ID [1]
280274
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Nil
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Universal Trial Number (UTN)
U1111-1129-7504
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Trial acronym
Supplemental Oxygen in Pulmonary Rehabilitation Trial (SuppORT)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
People with COPD who experience oxygen desaturation during exercise
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Exercise Training with supplemental oxygen.
Supplemental oxygen will be delivered to this group using an oxygen concentrator. Oxygen will be administered at a rate of 5 L/min oxygen via nasal prongs.
Exercise training will consist of supervised ground walk training and lower limb cycling three times per week for eight weeks. Both modes of training will be performed as this reflects current practice in pulmonary rehabilitation. The initial exercise intensity for each mode of training will be standardized. For walking training, the initial intensity will be set at 80% of the six minute walk test speed. For cycle training, the initial intensity will be 60% of the peak work rate estimated from an equation based on the 6MWT published by our group. The initial duration of exercise training will be 30 minutes (20 minutes walk and 10 minutes cycle). The duration of exercise will be progressed, up to a total duration of 40 minutes (20 minutes walk and 20 minutes cycle) by week 3.
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Intervention code [1]
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Rehabilitation
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
Exercise Training with medical air.
Oxygen concentrators altered to deliver medical air only, with Therapeutic Goods Administration (TGA) approval, will be used. Medical air will be administered at a rate of 5L/min via nasal prongs.
The exercise training component will be the same as for the intervention group.
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Control group
Active
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Outcomes
Primary outcome [1]
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Exercise capacity via endurance shuttle walk test time
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Assessment method [1]
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Timepoint [1]
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Baseline, eight weeks, six months
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Primary outcome [2]
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Health-related quality of life via chronic respiratory disease questionnaire (CRDQ)
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Assessment method [2]
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Timepoint [2]
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Baseline, eight weeks, six months
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Secondary outcome [1]
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Dyspnea via the CRDQ dyspnea domain and the Dyspnoea-12 questionnaire
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Assessment method [1]
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Timepoint [1]
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Baseline, eight weeks, six months
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Secondary outcome [2]
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Physical activity level via the SenseWear Armband
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Assessment method [2]
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Timepoint [2]
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Baseline, eight weeks, six months
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Secondary outcome [3]
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Peak exercise capacity via the incremental shuttle walk test
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Assessment method [3]
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Timepoint [3]
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Baseline, eight weeks, six months
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Eligibility
Key inclusion criteria
People will be eligible for inclusion if they:
a) have a medical diagnosis of COPD (forced expiratory volume in one second (FEV1) / forced vital capacity ratio of < 0.7; FEV1 between 20% to 80% predicted normal)
b) oxygen saturation < 90% during a 6MWT performed breathing room air.
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Minimum age
45
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
People will be excluded if they:
a) are receiving long term oxygen therapy or have a resting partial pressure of oxygen in arterial blood (PaO2) on room air less than or equal to 55 mmHg or have a resting PaCO2 greater then 50mmHg.
b) have musculoskeletal, cardiovascular or neurological conditions likely to adversely affect performance during assessments or training.
c) have participated in supervised exercise training within the last 12 months.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated, following informed consent, into one of two groups: Oxygen Group or Air Group. Equal numbers of participants will be randomised to each group. Allocation concealment will be achieved by the use of a central telephone randomisation system coordinated through the NHMRC Clinical Trials Centre at The University of Sydney.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be determined using a computerised random number generator with stratification for centre and level of desaturation at baseline (oxygen desaturation between 86%-89% vs oxygen desaturation <86%).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
6/08/2012
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Actual
7/01/2013
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Date of last participant enrolment
Anticipated
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Actual
19/05/2016
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Date of last data collection
Anticipated
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Actual
30/01/2017
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Sample size
Target
110
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Accrual to date
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Final
111
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Concord Repatriation Hospital - Concord
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Recruitment hospital [3]
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Liverpool Hospital - Liverpool
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Recruitment hospital [4]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [5]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [6]
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The Alfred - Prahran
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Recruitment hospital [7]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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4032 - Chermside
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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3004 - Prahran
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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GPO Box 1421 Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
Cumberland Campus C 42 (Faculty of Health Sciences)
75 East St
Lidcombe, Sydney, NSW 1825
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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University
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Name [1]
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Curtin University
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Address [1]
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GPO BOX U1987
Perth, WA 6845
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Country [1]
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Australia
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Other collaborator category [2]
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University
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Name [2]
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La Trobe University
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Address [2]
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Faculty of Health Sciences, La Trobe University
Plenty Rd,
Melbourne, Victoria 3086
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Country [2]
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Australia
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Other collaborator category [3]
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University
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Name [3]
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Griffith University
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Address [3]
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School of Physiotherapy and Exercise Science
Clinical Science 1 (G02) Room 1.04
Gold Coast campus
Parklands Drive
Southport Qld 4222
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Country [3]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Local Health District Research Ethics Committee (RPAH zone)
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Ethics committee address [1]
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c/- Research Development Office Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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24/01/2012
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Approval date [1]
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09/03/2012
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Ethics approval number [1]
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12/RPAH/25
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Ethics committee name [2]
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Human Resaerch Ethics Committee, The Prince Charles Hospital, Metro North Hospital and Health Service
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Ethics committee address [2]
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Administration Building Rode Road Chermside QLD 4032
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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27/07/2012
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Approval date [2]
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09/08/2012
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Ethics approval number [2]
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HREC/12/QPCH/148
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Ethics committee name [3]
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Human Ethics Committee Curtin University
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Ethics committee address [3]
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Office of Research and Development Building 100, Level 2 West Curtin University Kent Street Bentley, Western Australia 6102
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
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20/07/2012
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Approval date [3]
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22/08/2012
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Ethics approval number [3]
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HR 82/2012
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Ethics committee name [4]
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Austin Health Ethics Committee
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Ethics committee address [4]
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145 Studley Road Heidelberg Victoria 3084
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Ethics committee country [4]
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Australia
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Date submitted for ethics approval [4]
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12/07/2012
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Approval date [4]
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18/09/2012
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Ethics approval number [4]
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H2012/04755
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Ethics committee name [5]
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Human Ethics Committee South Western Sydney
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Ethics committee address [5]
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Research and Ethics Office Level 2, UNSW Clinical School Liverpool Hospital NSW 2170
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Ethics committee country [5]
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Australia
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Date submitted for ethics approval [5]
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26/09/2013
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Approval date [5]
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17/10/2013
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Ethics approval number [5]
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SSA/13/LPOOL/261 13/162
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Ethics committee name [6]
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Concord Hospital Ethics Committee
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Ethics committee address [6]
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Concord Hospital Hospital Road Concord NSW 2139
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Ethics committee country [6]
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Australia
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Date submitted for ethics approval [6]
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25/06/2012
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Approval date [6]
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23/07/2012
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Ethics approval number [6]
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SSA/12/CRGH/115
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Summary
Brief summary
Supplemental oxygen (O2) is the delivery of O2 when a person experiences O2 desaturation during activity. The use of supplemental O2 during exercise training for people with chronic obstructive pulmonary disease (COPD) is prescribed inconsistently and requires scientific evaluation. Since COPD is the second leading cause of avoidable hospital admissions and there are 47 percent of people with COPD referred to pulmonary rehabilitation who demonstrate O2 desaturation during exercise, whether to use supplemental O2 during exercise training is a substantial issue. Aim and Hypothesis: To determine whether supplemental O2 in people with COPD who desaturate during walking-based exercise provides greater benefit in exercise capacity and health-related quality of life than medical air. Exercise training with supplemental O2 will increase exercise capacity and health-related quality of life more than exercise training with medical air in people with COPD who desaturate during walking-based exercise. Design: This study is a national, multi-centre study where 110 participants with COPD will be recruited from sites in NSW, VIC, QLD, and WA. A prospective, double-blind, randomised controlled trial design will be used with COPD participants randomised into one of two groups: 1) receive intranasal cylinder O2 throughout exercise training (O2 group) or 2) receive intranasal cylinder medical air throughout exercise training (Air group). Participants will be asked to complete exercise tests and questionnaires at baseline, on completion of exercise training and at six month follow-up. This research will provide the first substantial and robust evidence regarding the role of supplemental O2 during exercise training for people with COPD who desaturate during exercise.
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Trial website
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Trial related presentations / publications
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) BMC Pulm Med. 2016 Feb 4;16:25. doi: 10.1186/s12890-016-0186-4.
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Public notes
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Attachments [1]
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/AnzctrAttachments/362167-a randomised control trial of supplemental oxgen vs medical air.pdf
(Publication)
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Contacts
Principal investigator
Name
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Prof Jennifer Alison
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Address
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THE UNIVERSITY OF SYDNEY
75 East Street
Lidcombe NSW 2141
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Country
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Australia
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Phone
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+61293519601
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jennifer Alison
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Address
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PO Box 170 Lidcombe, NSW 1825
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Country
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Australia
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Phone
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61 2 9351 9371
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Jennifer Alison
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Address
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PO Box 170 Lidcombe, NSW 1825
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Country
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Australia
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Phone
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61 2 9351 9371
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
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).
2016
https://dx.doi.org/10.1186/s12890-016-0186-4
Embase
Oxygen compared to air during exercise training in COPD with exercise-induced desaturation.
2019
https://dx.doi.org/10.1183/13993003.02429-2018
N.B. These documents automatically identified may not have been verified by the study sponsor.
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