Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000813482
Ethics application status
Approved
Date submitted
15/06/2016
Date registered
21/06/2016
Date last updated
21/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A survey on use of supplemental oxygen therapy during pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD)
Scientific title
A survey on use of supplemental oxygen therapy during pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD)
Secondary ID [1] 289353 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 298983 0
Condition category
Condition code
Respiratory 299161 299161 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A survey, which was specifically designed for this study, will be sent to pulmonary rehabilitation workers via email aiming to investigate the current practice about the use of supplemental oxygen therapy in pulmonary rehabilitation. The participation of the study is voluntary.
Intervention code [1] 295044 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298645 0
Data on the pattern of using oxygen therapy during exercise testing and exercise training in pulmonary rehabilitation
Timepoint [1] 298645 0
on survey completion
Secondary outcome [1] 324839 0
data on
- pattern of recording oxygen saturation, heart rate, dyspnoea, muscle fatigue, respiratory rate and blood pressure during exercise test
- availability of oxygen therapy during exercise testing and exercise training in pulmonary rehabilitation
- Protocol of oxygen therapy prescription / usage during exercise testing and training in pulmonary rehabilitation
- how pulmonary rehabilitation workers determine oxygen therapy prescription during exercise training in pulmonary rehabilitation for people with exercise induced desaturation
- rational for prescribing oxygen therapy during exercise training in pulmonary rehabilitation for people with exercise induced desaturation
Timepoint [1] 324839 0
on survey completion

Eligibility
Key inclusion criteria
pulmonary rehabilitation coordinators / workers of pulmonary rehabilitation program across Australia. An email will be sent with the participant information sheet and a link to the survey to all pulmonary rehabilitation programs which are listed on the database of the Lung Foundation Australia. Lung Foundation Australia will be sending the email on behalf of the project.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The survey will be sent to all existing pulmonary rehabilitation programs (based on the current Lung Foundation Australia contact list). This is aiming to capture as many programs as possible in order to understand the current practice of measuring, using and prescribing oxygen therapy in pulmonary rehabilitation.

As this is a survey, The total number of responses will be calculated and then divide by the total number in each category.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/01/2016
Date of last participant enrolment
Anticipated
31/08/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
265
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 293828 0
University
Name [1] 293828 0
The University of Sydney
Country [1] 293828 0
Australia
Primary sponsor type
Individual
Name
Wai Man Regina Leung
Address
Concord Hospital
Institute of Sports Medicine
Hospital Road
Concord 2139
Country
Australia
Secondary sponsor category [1] 292657 0
None
Name [1] 292657 0
none
Address [1] 292657 0
none
Country [1] 292657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295255 0
The University of Sydney
Ethics committee address [1] 295255 0
Research Integrity
Research Portfolio
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 295255 0
Australia
Date submitted for ethics approval [1] 295255 0
01/07/2015
Approval date [1] 295255 0
31/07/2015
Ethics approval number [1] 295255 0
2015/451

Summary
Brief summary
Exercise-induced oxygen desaturation is common in people with chronic lung diseases who are not on long-term oxygen therapy. Supplemental oxygen therapy is often used during exercise testing and training in pulmonary rehabilitation programs. However, there are no standard Australian guidelines on the use and prescription of supplemental oxygen therapy during exercise testing and training in this patient population so current practice remains unknown. Consequently, we are interested in investigating the use of supplemental oxygen therapy in pulmonary rehabilitation.

The study aims to evaluate the current pattern of prescribing and using supplemental oxygen therapy in pulmonary rehabilitation programs in Australia.
Trial website
https://surveys.sydney.edu.au/surveys/?s=B9Cjpn9DgU
Trial related presentations / publications
nil
Public notes
Attachments [1] 928 928 0 0
/AnzctrAttachments/370828-supplemental oxygen therapy in PR survey - final version.pdf

Contacts
Principal investigator
Name 66370 0
Dr Wai Man Regina Leung
Address 66370 0
Institute of Sports Medicine
Hospital Road
Concord NSW 2139
Australia
Country 66370 0
Australia
Phone 66370 0
+61297677602
Fax 66370 0
Email 66370 0
[email protected]
Contact person for public queries
Name 66371 0
Wai Man Regina Leung
Address 66371 0
Institute of Sports Medicine
Hospital Road
Concord NSW 2139
Australia
Country 66371 0
Australia
Phone 66371 0
+61297677602
Fax 66371 0
Email 66371 0
[email protected]
Contact person for scientific queries
Name 66372 0
Wai Man Regina Leung
Address 66372 0
Institute of Sports Medicine
Hospital Road
Concord NSW 2139
Australia
Country 66372 0
Australia
Phone 66372 0
+61297677602
Fax 66372 0
Email 66372 0
[email protected]

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
Dimensions AIUse of supplemental oxygen during exercise testing and training for people with chronic obstructive pulmonary disease: a survey of Australian pulmonary rehabilitation programs2020https://doi.org/10.1016/j.bjpt.2020.04.003
N.B. These documents automatically identified may not have been verified by the study sponsor.