Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000471684
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chest physiotherapy use and gastro-oesophageal reflux symptoms in adults with cystic fibrosis
Scientific title
Epidemiology of chest physiotherapy use and gastro-oesophageal reflux symptoms in adults with cystic fibrosis
Secondary ID [1] 177 0
X02-0045
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 590 0
Condition category
Condition code
Human Genetics and Inherited Disorders 662 662 0 0
Cystic fibrosis
Physical Medicine / Rehabilitation 663 663 0 0
Physiotherapy
Public Health 664 664 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The interventions are (1) postural drainage, (2) PEP, (3) oscillating PEP, (4) AD, (5) Huff, (6) Percussion, (7) ACBT, (8) Other. This is an epidemiological study so treatment use is determined by the patients' usual practice. The period examined is the previous 4 weeks.
Intervention code [1] 409 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 790 0
Reflux severity over the previous 4 weeks.
Timepoint [1] 790 0
Secondary outcome [1] 1598 0
Reflux frequency
Timepoint [1] 1598 0
Secondary outcome [2] 1599 0
Anti-reflux medication use over previous 4 weeks.
Timepoint [2] 1599 0

Eligibility
Key inclusion criteria
Cystic fibrosis, member of RPA Hospital CF Clinic.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable/unwilling to provide informed consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/12/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 732 0
Self funded/Unfunded
Name [1] 732 0
Country [1] 732 0
Primary sponsor type
Government body
Name
Sydney South West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 607 0
None
Name [1] 607 0
Nil
Address [1] 607 0
Country [1] 607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1927 0
Sydney South West Area Health Service Ethics Review Committee
Ethics committee address [1] 1927 0
Ethics committee country [1] 1927 0
Australia
Date submitted for ethics approval [1] 1927 0
Approval date [1] 1927 0
Ethics approval number [1] 1927 0

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

Contacts
Principal investigator
Name 36254 0
Address 36254 0
Country 36254 0
Phone 36254 0
Fax 36254 0
Email 36254 0
Contact person for public queries
Name 9598 0
Ms Wendy Taylor
Address 9598 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9598 0
Australia
Phone 9598 0
+61 2 95156578
Fax 9598 0
+61 2 95505865
Email 9598 0
[email protected]
Contact person for scientific queries
Name 526 0
Mr Mark Elkins
Address 526 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
Level 11 E Block
Missenden Road
Camperdown NSW 2050
Country 526 0
Australia
Phone 526 0
+61 2 95158712
Fax 526 0
+61 2 95158196
Email 526 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
No additional documents have been identified.