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Trial registered on ANZCTR


Registration number
ACTRN12605000535673
Ethics application status
Approved
Date submitted
27/09/2005
Date registered
28/09/2005
Date last updated
28/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acute effects of physiotherapy on gas exchange and well-being in patients with cystic fibrosis.
Scientific title
The acute effects of physiotherapy on gas exchange and well-being in patients with cystic fibrosis.
Universal Trial Number (UTN)
Trial acronym
Physiotherapy and gas exchange
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis. 661 0
Condition category
Condition code
Human Genetics and Inherited Disorders 734 734 0 0
Cystic fibrosis
Physical Medicine / Rehabilitation 735 735 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized crossover study looking at the acute effects of a single chest physiotherapy treatment on detailed gas exchange measured by MIGET (multiple inert gas elimination technique).
Intervention code [1] 681 0
Treatment: Other
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 905 0
The effects of a chest physiotherapy treatment on spirometry
Timepoint [1] 905 0
2 hours after therapy
Primary outcome [2] 906 0
The effects of a chest physiotherapy treatment on ABG
Timepoint [2] 906 0
2 hours after therapy
Primary outcome [3] 907 0
The effects of a chest physiotherapy treatment on MIGET gas exchange
Timepoint [3] 907 0
2 hours after therapy
Primary outcome [4] 908 0
The effects of a chest physiotherapy treatment on well-being
Timepoint [4] 908 0
2 hours after therapy
Secondary outcome [1] 1762 0
The correlation between physiological changes following chest physiotherapy and well-being.
Timepoint [1] 1762 0
Two hours following physiotherapy therapy.

Eligibility
Key inclusion criteria
A diagnosis of cystic fibrosis, stable state with the production of at least 30ml sputum with chest physiotherapy.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Factors compromising chest physiotherapy eg. pneumothorax.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of chest physiotherapy or no treatment determined by coin-toss. Crossover study as per 13.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 816 0
Government body
Name [1] 816 0
Australian NHMRC personal scholarship
Address [1] 816 0
Country [1] 816 0
Australia
Primary sponsor type
Government body
Name
Australian NHMRC personal scholarship
Address
Country
Australia
Secondary sponsor category [1] 682 0
None
Name [1] 682 0
N/A
Address [1] 682 0
Country [1] 682 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2082 0
Central Sydney Area Health Service Ethics Committee
Ethics committee address [1] 2082 0
Ethics committee country [1] 2082 0
Australia
Date submitted for ethics approval [1] 2082 0
Approval date [1] 2082 0
Ethics approval number [1] 2082 0

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

Contacts
Principal investigator
Name 35399 0
Address 35399 0
Country 35399 0
Phone 35399 0
Fax 35399 0
Email 35399 0
Contact person for public queries
Name 9870 0
Ms Wendy Taylor
Address 9870 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Rd
Camperdown NSW 2050
Country 9870 0
Australia
Phone 9870 0
+61 2 95156578
Fax 9870 0
+61 2 95505865
Email 9870 0
wtaylor@woolcock.org.au
Contact person for scientific queries
Name 798 0
Dr Rajeev Soni
Address 798 0
PO Box 361
Gosford NSW 2250
Country 798 0
Australia
Phone 798 0
+61 2 43202792
Fax 798 0
+61 2 43202042
Email 798 0
rsoni@nsccahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary