Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000422628
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of exercise on mucus rheology and inspiratory/expiratory flow-volume relationships in people with Cystic Fibrosis
Scientific title
Effect of cycle and treadmill endurance exercise on mucus rheology and inspiratory/expiratory flow-volume relationships in people with Cystic Fibrosis
Secondary ID [1] 287895 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 531 0
Condition category
Condition code
Human Genetics and Inherited Disorders 611 611 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stable subjects will attend for testing on three days. First day, lung function and incremental cycle and treadmill tests to peak work capacity (randomised order) will be performed. On the second and third day, subjects will be randomised to perform 20 minutes of endurance exercise at 60% of peak work capacity on the cycle ergometer and the treadmill.
Intervention code [1] 501 0
None
Comparator / control treatment
Control treatment was resting breathing for 20 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 713 0
Mucus rheology. Samples collected are control-separated by 20 minutes.
Timepoint [1] 713 0
At pre-exercise, immediately post-exercise and 20 minutes post-exercise
Primary outcome [2] 714 0
Inspiratory and expiratory flow-volume relationships
Timepoint [2] 714 0
Recorded throughout peak and endurance exercise tests
Secondary outcome [1] 1474 0
Subjective ease of expectoration
Timepoint [1] 1474 0
Immediately pre-intervention, immediately post-intervention, 20 minutes post-intervention
Secondary outcome [2] 1475 0
Comparison of bike versus treadmill exercise capacity and effect on mucus rheology and flow-volume relationships.
Timepoint [2] 1475 0
Immediately pre-intervention, immediately post-intervention, 20 minutes post-intervention
Secondary outcome [3] 1476 0
Comparison of peak and endurance exercise capacity.
Timepoint [3] 1476 0
Measurements taken each minute throughout the 20 minutes of endurance exercise and throughout the peak exercsise test.

Eligibility
Key inclusion criteria
Diagnosed with cystic fibrosis
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Post lung transplant; infected with burkholderia cepacia complex; not clinically stable

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2005
Actual
25/05/2005
Date of last participant enrolment
Anticipated
Actual
6/07/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 668 0
Government body
Name [1] 668 0
NHMRC
Country [1] 668 0
Australia
Primary sponsor type
Government body
Name
SWSAHS
Address
Level 11, KGV Building
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 557 0
None
Name [1] 557 0
None
Address [1] 557 0
Country [1] 557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1849 0
Royal Prince Alfred Hospital
Ethics committee address [1] 1849 0
Ethics committee country [1] 1849 0
Australia
Date submitted for ethics approval [1] 1849 0
Approval date [1] 1849 0
09/03/2005
Ethics approval number [1] 1849 0

Summary
Brief summary
The trial completed recruitment and data collection in 2007. Manuscript was published in Chest 2011, vol 139(4):870-877.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35501 0
Prof Jennifer Alison
Address 35501 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
East Street
Lidcombe NSW 2141
Country 35501 0
Australia
Phone 35501 0
+61 2 93519371
Fax 35501 0
Email 35501 0
[email protected]
Contact person for public queries
Name 9690 0
Dr Tiffany Dwyer
Address 9690 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
11 West
Missenden Road
Camperdown NSW 2050
Country 9690 0
Australia
Phone 9690 0
+61 2 95155234
Fax 9690 0
+61 2 95158196
Email 9690 0
[email protected]
Contact person for scientific queries
Name 618 0
Prof Jennifer Alison
Address 618 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
East Street
Lidcombe NSW 2141
Country 618 0
Australia
Phone 618 0
+61 2 93519371
Fax 618 0
+61 2 93519601
Email 618 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.