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Trial registered on ANZCTR


Registration number
ACTRN12609000168257
Ethics application status
Approved
Date submitted
26/02/2009
Date registered
6/04/2009
Date last updated
19/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of exercise compared to chest physiotherapy on mucus clearance in cystic fibrosis
Scientific title
Effect of exercise compared to chest physiotherapy on mucus rheology and respiratory flow rates in cystic fibrosis
Secondary ID [1] 287942 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cystic fibrosis 4394 0
Condition category
Condition code
Human Genetics and Inherited Disorders 4639 4639 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Treadmill exercise, speed and incline set to achieve an exercise intensity of 60% of each subject's peak oxygen uptake (VO2) for 20 minutes on one occasion. Peak VO2 measured on the day prior to randomisation.
Group 2: Chest physiotherapy. Subjects breath out through a Flutter device which provides an oscillating expiratory pressure at the mouth of 10-20cmH2O. Subjects breath out through this device for two minutes, followed by the Forced Expiratory Techinique. This cycle is repeated six times in a 20 minute period on one occasion.
Group 3: Control (resting breathing). Sitting quietly, relaxed breathing for 20 minutes on one occasion.
There is a minimum of 24 hours "wash out" between interventions. All three interventions to be completed within two weeks
Intervention code [1] 4125 0
Treatment: Devices
Intervention code [2] 4126 0
Treatment: Other
Comparator / control treatment
Group 2 and Group 3 as described above act as the control groups
Control group
Active

Outcomes
Primary outcome [1] 5509 0
mucus properties (viscosity, elasticity, solids content)
Timepoint [1] 5509 0
pre-intervention, during intervention, immediately post-intervention and 20 minutes post-intervention
Primary outcome [2] 5510 0
respiratory flow rates (peak expiratory flow rate, peak inspiratory flow rate, ratio between peak expiratory:peak inspiratory flow rate)
Timepoint [2] 5510 0
pre-intervention, during intervention and 20 minutes post-intervention
Secondary outcome [1] 9272 0
subjective ease of expectoration, measured on a 10cm visual analogue scale
Timepoint [1] 9272 0
pre-intervention, during intervention, immediately post-intervention, 20 minutes post-intervention
Secondary outcome [2] 9273 0
subjective feeling of lung congestion, measured on a 10cm visual analogue scale
Timepoint [2] 9273 0
pre-intervention, immediately post-intervention and 20 minutes post-intervention
Secondary outcome [3] 9274 0
lung function using spirometry
Timepoint [3] 9274 0
pre-intervention, 20 minutes post-intervention

Eligibility
Key inclusion criteria
diagnosed with cystic fibrosis,
stable clinical condition
Minimum age
17 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous lung transplant, pregnant

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)
concealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generation, using a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
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] 4569 0
Government body
Name [1] 4569 0
Australian Respiratory Council - Harry Windsor Research Grant
Address [1] 4569 0
GPO Box 102
Sydney NSW 2001
Country [1] 4569 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 4122 0
University
Name [1] 4122 0
University of Sydney
Address [1] 4122 0
Research Office A14 Main Quadrangle University of Sydney NSW 2006
Country [1] 4122 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6619 0
Sydney South West Area Health Service
Ethics committee address [1] 6619 0
Ethics Review Committee
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 6619 0
Australia
Date submitted for ethics approval [1] 6619 0
Approval date [1] 6619 0
01/08/2008
Ethics approval number [1] 6619 0
X08-0175

Summary
Brief summary
We aim to examine the effect of exercise, compared to chest physiotherapy and control, on mechanisms of airway clearance in cystic fibrosis. We hypothesise that exercise and chest physiotherapy will improve respiratory flow rates and properties of mucus.
Trial website
Trial related presentations / publications
Dwyer T, Zainuldin M, Daviskas E, Bye P, Mellis C, Alison J. "Effects of exercise and Flutter (Registered Trademark) on respiratory flow and sputum properties in adults with cystic fibrosis". 9th Australasian Cystic Fibrosis Conference, Melbourne, Australia. 2011:p17-18.

Dwyer T. “Exercise for airway clearance”. 34th European Cystic Fibrosis Conference, Hamburg, Germany. 2011 (invited speaker, no abstract).
Public notes

Contacts
Principal investigator
Name 29330 0
Prof Jennifer Alison
Address 29330 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
East Street
Lidcombe NSW 2141
Country 29330 0
Australia
Phone 29330 0
+61 2 93519371
Fax 29330 0
Email 29330 0
jennifer.alison@sydney.edu.au
Contact person for public queries
Name 12577 0
Prof Jennifer Alison
Address 12577 0
Head of Discipline
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 12577 0
Australia
Phone 12577 0
+61293519371
Fax 12577 0
Email 12577 0
jennifer.alison@sydney.edu.au
Contact person for scientific queries
Name 3505 0
Prof Jennifer Alison
Address 3505 0
Head of Discipline
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 3505 0
Australia
Phone 3505 0
+61293519371
Fax 3505 0
Email 3505 0
jennifer.alison@sydney.edu.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