Trial Review

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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)
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
Secondary ID [1] 280274 0
Nil
Universal Trial Number (UTN)
U1111-1129-7504
Trial acronym
Supplemental Oxygen in Pulmonary Rehabilitation Trial (SuppORT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with COPD who experience oxygen desaturation during exercise 286227 0
Condition category
Condition code
Respiratory 286443 286443 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 284626 0
Rehabilitation
Intervention code [2] 284632 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 286890 0
Exercise capacity via endurance shuttle walk test time
Timepoint [1] 286890 0
Baseline, eight weeks, six months
Primary outcome [2] 286891 0
Health-related quality of life via chronic respiratory disease questionnaire (CRDQ)
Timepoint [2] 286891 0
Baseline, eight weeks, six months
Secondary outcome [1] 296918 0
Dyspnea via the CRDQ dyspnea domain and the Dyspnoea-12 questionnaire
Timepoint [1] 296918 0
Baseline, eight weeks, six months
Secondary outcome [2] 296919 0
Physical activity level via the SenseWear Armband
Timepoint [2] 296919 0
Baseline, eight weeks, six months
Secondary outcome [3] 296920 0
Peak exercise capacity via the incremental shuttle walk test
Timepoint [3] 296920 0
Baseline, eight weeks, six months

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.
Minimum age
45 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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%).
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2012
Actual
7/01/2013
Date of last participant enrolment
Anticipated
Actual
19/05/2016
Date of last data collection
Anticipated
Actual
30/01/2017
Sample size
Target
110
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 12152 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 12153 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 12154 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 12155 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 12156 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [6] 12157 0
The Alfred - Prahran
Recruitment hospital [7] 12158 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 24321 0
2050 - Camperdown
Recruitment postcode(s) [2] 24322 0
2139 - Concord
Recruitment postcode(s) [3] 24323 0
2170 - Liverpool
Recruitment postcode(s) [4] 24326 0
3004 - Prahran
Recruitment postcode(s) [5] 24325 0
3084 - Heidelberg
Recruitment postcode(s) [6] 24324 0
4032 - Chermside
Recruitment postcode(s) [7] 24327 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 285042 0
Government body
Name [1] 285042 0
National Health and Medical Research Council
Country [1] 285042 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Cumberland Campus C 42 (Faculty of Health Sciences)
75 East St
Lidcombe, Sydney, NSW 1825
Country
Australia
Secondary sponsor category [1] 283906 0
None
Name [1] 283906 0
Address [1] 283906 0
Country [1] 283906 0
Other collaborator category [1] 260703 0
University
Name [1] 260703 0
Curtin University
Address [1] 260703 0
GPO BOX U1987
Perth, WA 6845
Country [1] 260703 0
Australia
Other collaborator category [2] 260704 0
University
Name [2] 260704 0
La Trobe University
Address [2] 260704 0
Faculty of Health Sciences, La Trobe University
Plenty Rd,
Melbourne, Victoria 3086
Country [2] 260704 0
Australia
Other collaborator category [3] 260705 0
University
Name [3] 260705 0
Griffith University
Address [3] 260705 0
School of Physiotherapy and Exercise Science
Clinical Science 1 (G02) Room 1.04
Gold Coast campus
Parklands Drive
Southport Qld 4222
Country [3] 260705 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287048 0
Sydney Local Health District Research Ethics Committee (RPAH zone)
Ethics committee address [1] 287048 0
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 287048 0
Australia
Date submitted for ethics approval [1] 287048 0
24/01/2012
Approval date [1] 287048 0
09/03/2012
Ethics approval number [1] 287048 0
12/RPAH/25
Ethics committee name [2] 301685 0
Human Resaerch Ethics Committee, The Prince Charles Hospital, Metro North Hospital and Health Service
Ethics committee address [2] 301685 0
Administration Building
Rode Road
Chermside QLD 4032
Ethics committee country [2] 301685 0
Australia
Date submitted for ethics approval [2] 301685 0
27/07/2012
Approval date [2] 301685 0
09/08/2012
Ethics approval number [2] 301685 0
HREC/12/QPCH/148
Ethics committee name [3] 301686 0
Human Ethics Committee Curtin University
Ethics committee address [3] 301686 0
Office of Research and Development
Building 100, Level 2 West
Curtin University
Kent Street
Bentley, Western Australia 6102
Ethics committee country [3] 301686 0
Australia
Date submitted for ethics approval [3] 301686 0
20/07/2012
Approval date [3] 301686 0
22/08/2012
Ethics approval number [3] 301686 0
HR 82/2012
Ethics committee name [4] 301687 0
Austin Health Ethics Committee
Ethics committee address [4] 301687 0
145 Studley Road
Heidelberg
Victoria 3084
Ethics committee country [4] 301687 0
Australia
Date submitted for ethics approval [4] 301687 0
12/07/2012
Approval date [4] 301687 0
18/09/2012
Ethics approval number [4] 301687 0
H2012/04755
Ethics committee name [5] 301688 0
Human Ethics Committee South Western Sydney
Ethics committee address [5] 301688 0
Research and Ethics Office
Level 2, UNSW Clinical School
Liverpool Hospital
NSW 2170
Ethics committee country [5] 301688 0
Australia
Date submitted for ethics approval [5] 301688 0
26/09/2013
Approval date [5] 301688 0
17/10/2013
Ethics approval number [5] 301688 0
SSA/13/LPOOL/261 13/162
Ethics committee name [6] 301689 0
Concord Hospital Ethics Committee
Ethics committee address [6] 301689 0
Concord Hospital
Hospital Road
Concord NSW 2139
Ethics committee country [6] 301689 0
Australia
Date submitted for ethics approval [6] 301689 0
25/06/2012
Approval date [6] 301689 0
23/07/2012
Ethics approval number [6] 301689 0
SSA/12/CRGH/115

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.
Trial website
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.
Public notes
Attachments [1] 3156 3156 0 0
/AnzctrAttachments/362167-a randomised control trial of supplemental oxgen vs medical air.pdf (Publication)

Contacts
Principal investigator
Name 33845 0
Prof Jennifer Alison
Address 33845 0
THE UNIVERSITY OF SYDNEY
75 East Street
Lidcombe NSW 2141
Country 33845 0
Australia
Phone 33845 0
+61293519601
Fax 33845 0
Email 33845 0
jennifer.alison@sydney.edu.au
Contact person for public queries
Name 17092 0
Prof Jennifer Alison
Address 17092 0
PO Box 170 Lidcombe, NSW 1825
Country 17092 0
Australia
Phone 17092 0
61 2 9351 9371
Fax 17092 0
Email 17092 0
jennifer.alison@sydney.edu.au
Contact person for scientific queries
Name 8020 0
Prof Jennifer Alison
Address 8020 0
PO Box 170 Lidcombe, NSW 1825
Country 8020 0
Australia
Phone 8020 0
61 2 9351 9371
Fax 8020 0
Email 8020 0
jennifer.alison@sydney.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseOxygen compared to air during exercise training in COPD with exercise-induced desaturation.2019https://dx.doi.org/10.1183/13993003.02429-2018
EmbaseA 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).2016https://dx.doi.org/10.1186/s12890-016-0186-4
N.B. These documents automatically identified may not have been verified by the study sponsor.