Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000994482
Ethics application status
Approved
Date submitted
26/07/2016
Date registered
28/07/2016
Date last updated
8/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise and airway clearance practices of adults with cystic fibrosis: current Australian practice.
Scientific title
Exercise and airway clearance practices of adults with cystic fibrosis: current Australian practice.
Secondary ID [1] 289717 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 299538 0
Condition category
Condition code
Human Genetics and Inherited Disorders 299519 299519 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will self-complete a purpose-specific questionnaire that assesses their current practices in relation to exercise and airway clearance techniques over the previous three months. The questionnaire also investigates the participants' beliefs about exercise as a form of airway secretion clearance. The questionnaire collects various demographic data. Participants will only complete the questionnaire once, either during an outpatient appointment or during an inpatient admission.
Intervention code [1] 295350 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298998 0
Percentage of participants utilising each type of airway clearance technique as assessed by the study-specific questionnaire.
Timepoint [1] 298998 0
At time of questionnaire completion.
Primary outcome [2] 299064 0
Percentage of patients using each form of exercise as assessed by the study-specific questionnaire.
Timepoint [2] 299064 0
At time of questionnaire completion.
Secondary outcome [1] 325844 0
Percentage reporting that exercise is a substitute or alternative to traditional airway clearance techniques as assessed by the study-specific questionnaire.
Timepoint [1] 325844 0
At time of questionnaire completion.

Eligibility
Key inclusion criteria
Diagnosis of CF
Attending a participating adult CF service/site
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent (e.g. critically unwell, terminal end of life care)
Unwilling to participate
Inability to understand written English
Post lung transplantation
Participation in an exercise or ACT interventional study in the last three months.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Demographic characteristics and airway clearance/exercise practices will be reported using descriptive statistics. Comparisons between those using exercise as a form of airway clearance, exercise to improve the effectiveness of their traditional airway clearance techniques and those who do not use exercise as a form or airway clearance will be assessed for normality and analysed using the corresponding tests. As this is a cross-sectional study to determine current clinical practice, there are no suitable data to determine a minimum sample size. Recruitment will occur at each site for 3 months or until 100% of patients at the clinic have participated, whichever occurs first. In 2013, there were 1613 adults listed on the Australian Cystic Fibrosis Data Registry. It is hoped that between 600-800 individuals Australia-wide will be recruited.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2017
Actual
1/02/2017
Date of last participant enrolment
Anticipated
30/06/2017
Actual
31/07/2017
Date of last data collection
Anticipated
30/04/2017
Actual
31/07/2017
Sample size
Target
600
Accrual to date
Final
712
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 6250 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 6251 0
Royal Hobart Hospital - Hobart
Recruitment hospital [3] 6252 0
Launceston General Hospital - Launceston
Recruitment hospital [4] 6253 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [5] 6254 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [6] 6255 0
Gold Coast University Hospital - Southport
Recruitment hospital [7] 6256 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [8] 6257 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [9] 6258 0
The Prince Charles Hospital - Chermside
Recruitment hospital [10] 6259 0
The Alfred - Prahran
Recruitment hospital [11] 6260 0
Westmead Hospital - Westmead
Recruitment hospital [12] 6261 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [13] 6262 0
Gosford Hospital - Gosford
Recruitment hospital [14] 7409 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 13685 0
5000 - Adelaide
Recruitment postcode(s) [2] 13686 0
7000 - Hobart
Recruitment postcode(s) [3] 13687 0
7250 - Launceston
Recruitment postcode(s) [4] 13688 0
6009 - Nedlands
Recruitment postcode(s) [5] 13689 0
2305 - New Lambton
Recruitment postcode(s) [6] 13690 0
4215 - Southport
Recruitment postcode(s) [7] 13691 0
4101 - South Brisbane
Recruitment postcode(s) [8] 13692 0
2050 - Camperdown
Recruitment postcode(s) [9] 13693 0
4032 - Chermside
Recruitment postcode(s) [10] 13694 0
3004 - Prahran
Recruitment postcode(s) [11] 13695 0
2145 - Westmead
Recruitment postcode(s) [12] 13696 0
3168 - Clayton
Recruitment postcode(s) [13] 13697 0
2250 - Gosford
Recruitment postcode(s) [14] 15211 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 294140 0
Hospital
Name [1] 294140 0
Royal Adelaide Hospital
Country [1] 294140 0
Australia
Primary sponsor type
Individual
Name
Nathan Ward
Address
c/o Physiotherapy
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 292969 0
None
Name [1] 292969 0
Not applicable
Address [1] 292969 0
Not applicable
Country [1] 292969 0
Other collaborator category [1] 279098 0
Individual
Name [1] 279098 0
Dr Kathy Stiller
Address [1] 279098 0
c/o Allied Health
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 279098 0
Australia
Other collaborator category [2] 279099 0
Individual
Name [2] 279099 0
Prof Anne Holland
Address [2] 279099 0
La Trobe University Clinical School
Alfred Health
Level 4
The Alfred Centre
99 Commercial Rd
Melbourne
Vic 3004
Country [2] 279099 0
Australia
Other collaborator category [3] 279100 0
Individual
Name [3] 279100 0
Hilary Rowe
Address [3] 279100 0
c/o Physiotherapy
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [3] 279100 0
Australia
Other collaborator category [4] 279101 0
Individual
Name [4] 279101 0
Scott Morrow
Address [4] 279101 0
c/o Physiotherapy
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [4] 279101 0
Australia
Other collaborator category [5] 279102 0
Individual
Name [5] 279102 0
Jenny Hauser
Address [5] 279102 0
c/o Physiotherapy Department
Royal Hobart Hospital
GPO Box 1061
Hobart
TAS 7001
Country [5] 279102 0
Australia
Other collaborator category [6] 279103 0
Individual
Name [6] 279103 0
Jenn Bingham
Address [6] 279103 0
c/o Physiotherapy Department
Royal Hobart Hospital
GPO Box 1061
Hobart
TAS 7001
Country [6] 279103 0
Australia
Other collaborator category [7] 279104 0
Individual
Name [7] 279104 0
Jamie Wood
Address [7] 279104 0
c/o Physiotherapy Department
Sir Charles Gairdner Hospital
A Block
Hospital Avenue
Nedlands
WA 6009
Country [7] 279104 0
Australia
Other collaborator category [8] 279105 0
Individual
Name [8] 279105 0
Tara Smith
Address [8] 279105 0
c/o Physiotherapy Department
John Hunter Hospital
Lookout Rd
New Lambton Heights
NSW 2305
Country [8] 279105 0
Australia
Other collaborator category [9] 279106 0
Individual
Name [9] 279106 0
Rebecca Netluch
Address [9] 279106 0
c/o Physiotherapy Department
John Hunter Hospital
Lookout Rd
New Lambton Heights
NSW 2305
Country [9] 279106 0
Australia
Other collaborator category [10] 279107 0
Individual
Name [10] 279107 0
Andrew Shaw
Address [10] 279107 0
c/o Physiotherapy Department
Gold Coast University Hospital
D Block
1 Hospital Boulevard
Southport
QLD 4215
Country [10] 279107 0
Australia
Other collaborator category [11] 279108 0
Individual
Name [11] 279108 0
Danielle Shortall
Address [11] 279108 0
c/o Physiotherapy Department
Mater Hospital Brisbane
Raymond Terrace
South Brisbane
QLD 4101
Country [11] 279108 0
Australia
Other collaborator category [12] 279109 0
Individual
Name [12] 279109 0
Dr Ruth Dentice
Address [12] 279109 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
Level 11W
Missenden Rd
Camperdown
NSW 2050
Country [12] 279109 0
Australia
Other collaborator category [13] 279110 0
Individual
Name [13] 279110 0
Kathleen Hall
Address [13] 279110 0
c/o Physiotherapy Department
Allied Health
The Prince Charles Hospital
Rode Rd
Chermside
QLD 4032
Country [13] 279110 0
Australia
Other collaborator category [14] 279111 0
Individual
Name [14] 279111 0
Robyn Cobb
Address [14] 279111 0
c/o Physiotherapy Department
Allied Health
The Prince Charles Hospital
Rode Rd
Chermside
QLD 4032
Country [14] 279111 0
Australia
Other collaborator category [15] 279112 0
Individual
Name [15] 279112 0
Rebecca Chambers
Address [15] 279112 0
c/o Physiotherapy Department
Allied Health
The Prince Charles Hospital
Rode Rd
Chermside
QLD 4032
Country [15] 279112 0
Australia
Other collaborator category [16] 279113 0
Individual
Name [16] 279113 0
A/Prof Brenda Button
Address [16] 279113 0
c/o Physiotherapy Department
The Alfred Hospital
PO Box 315
Prahran
VIC 3181
Country [16] 279113 0
Australia
Other collaborator category [17] 279114 0
Individual
Name [17] 279114 0
Jennifer Bishop
Address [17] 279114 0
c/o Adult Cystic Fibrosis Unit
Westmead Hospital
PO Box 533
Wentworthville
NSW 2145
Country [17] 279114 0
Australia
Other collaborator category [18] 279115 0
Individual
Name [18] 279115 0
Jennifer Corda
Address [18] 279115 0
c/o Allied Health
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Country [18] 279115 0
Australia
Other collaborator category [19] 279116 0
Individual
Name [19] 279116 0
Amanda Nichols
Address [19] 279116 0
c/o Allied Health
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Country [19] 279116 0
Australia
Other collaborator category [20] 279117 0
Individual
Name [20] 279117 0
Clare Chung
Address [20] 279117 0
c/o Physiotherapy Department
Gosford Hospital
Holden St
Gosford
NSW 2250
Country [20] 279117 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295552 0
Royal Adelaide Hospital
Ethics committee address [1] 295552 0
Ethics committee country [1] 295552 0
Australia
Date submitted for ethics approval [1] 295552 0
27/04/2016
Approval date [1] 295552 0
21/06/2016
Ethics approval number [1] 295552 0
HREC/16/RAH/173
Ethics committee name [2] 295553 0
La Trobe University
Ethics committee address [2] 295553 0
Ethics committee country [2] 295553 0
Australia
Date submitted for ethics approval [2] 295553 0
19/07/2016
Approval date [2] 295553 0
25/07/2016
Ethics approval number [2] 295553 0
HREC/16/RAH173 - Holland/Ward
Ethics committee name [3] 296808 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [3] 296808 0
Ethics committee country [3] 296808 0
Australia
Date submitted for ethics approval [3] 296808 0
26/07/2016
Approval date [3] 296808 0
03/08/2016
Ethics approval number [3] 296808 0
2016-110
Ethics committee name [4] 296809 0
Tasmanian Human Research Ethics Committee
Ethics committee address [4] 296809 0
Ethics committee country [4] 296809 0
Australia
Date submitted for ethics approval [4] 296809 0
19/07/2016
Approval date [4] 296809 0
05/09/2016
Ethics approval number [4] 296809 0
H0015945
Ethics committee name [5] 296810 0
ACT Health Human Research Ethics Committee
Ethics committee address [5] 296810 0
Ethics committee country [5] 296810 0
Australia
Date submitted for ethics approval [5] 296810 0
12/12/2016
Approval date [5] 296810 0
13/12/2016
Ethics approval number [5] 296810 0
ETH.1.17.009E

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67558 0
Mr Nathan Ward
Address 67558 0
c/o Physiotherapy
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 67558 0
Australia
Phone 67558 0
+61882225574
Fax 67558 0
Email 67558 0
nathan.ward2@sa.gov.au
Contact person for public queries
Name 67559 0
Nathan Ward
Address 67559 0
c/o Physiotherapy
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 67559 0
Australia
Phone 67559 0
+61882225574
Fax 67559 0
Email 67559 0
nathan.ward2@sa.gov.au
Contact person for scientific queries
Name 67560 0
Nathan Ward
Address 67560 0
c/o Physiotherapy
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 67560 0
Australia
Phone 67560 0
+61882225574
Fax 67560 0
Email 67560 0
nathan.ward2@sa.gov.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
No additional documents have been identified.