Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000287336
Ethics application status
Approved
Date submitted
26/05/2008
Date registered
4/06/2008
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Does exercise enhance mucociliary clearance in adults with cystic fibrosis?
Scientific title
Exercise for mucus clearance in cystic fibrosis
Secondary ID [1] 287928 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cystic fibrosis 3186 0
Condition category
Condition code
Human Genetics and Inherited Disorders 3348 3348 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treadmill exercise, speed and incline set to achieve an exercise intensity of 60% of each subject's peak VO2 for 20 minutes on one occasion. Peak VO2 measured on the day prior to randomisation.
Positive expiratory pressure (PEP). Subjects breath through a PEP device which provides an expiratory pressure at the mouth of 15-20cmH2O. Subjects breath through this device for 15 breaths, followed by the Forced Expiratory Techinique. This cycle is repeated six times in a 20 minute period on one occasion.
Control (resting breathing). Sitting quietly, relaxed breathing for 20 minutes on one occasion.
Intervention code [1] 2918 0
Treatment: Other
Intervention code [2] 2968 0
Treatment: Devices
Intervention code [3] 2969 0
Treatment: Other
Comparator / control treatment
Positive expiratory pressure (PEP). Subjects breath through a PEP device which provides an expiratory pressure at the mouth of 15-20cmH2O. Subjects breath through this device for 15 breaths, followed by the Forced Expiratory Techinique. This cycle is repeated six times in a 20 minute period on one occasion.
Control (resting breathing). Sitting quietly, relaxed breathing for 20 minutes on one occasion.
Control group
Active

Outcomes
Primary outcome [1] 4239 0
mucociliary clearance, measured by inhaled radioaerosol
Timepoint [1] 4239 0
pre-intervention,
immediately post intervention,
1 hour post intervention
Secondary outcome [1] 7160 0
subjective feeling of lung congestion, measured on a 10cm visual analogue scale
Timepoint [1] 7160 0
pre-intervention,
immediately post intervention,
1 hour post intervention
Secondary outcome [2] 7161 0
subjective ease of expectoration, measured on a 10cm visual analogue scale
Timepoint [2] 7161 0
pre-intervention,
during intervention,
1 hour post intervention
Secondary outcome [3] 7162 0
spirometry
Timepoint [3] 7162 0
pre-intervention,
1 hour post intervention

Eligibility
Key inclusion criteria
diagnosed with cystic fibrosis,
stable clinical condition
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous lung transplant,
pregnant,
if participation resulted in the 5 year radiation does for volunteers being exceeded

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
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2008
Actual
8/08/2008
Date of last participant enrolment
Anticipated
Actual
14/04/2011
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] 3423 0
Charities/Societies/Foundations
Name [1] 3423 0
Australian Cystic Fibrosis Research Trust
Country [1] 3423 0
Australia
Funding source category [2] 3424 0
University
Name [2] 3424 0
University of Sydney
Country [2] 3424 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 3066 0
University
Name [1] 3066 0
University of Sydney
Address [1] 3066 0
Research Office
A14 Main Quadrangle
University of Sydney 2006
Country [1] 3066 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5446 0
Sydney South West Area Health Service
Ethics committee address [1] 5446 0
Ethics Review Committee
Page 8
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 5446 0
Australia
Date submitted for ethics approval [1] 5446 0
Approval date [1] 5446 0
12/03/2008
Ethics approval number [1] 5446 0
X08-0300

Summary
Brief summary
The trial completed recruitment and data collection in 2011. Results presented at the European Cystic Fibrosis Conference and the Australasian Cystic Fibrosis Conference in 2011. Manuscript under preparation.
Trial website
Trial related presentations / publications
Dwyer T, Daviskas E, Zainuldin M, Verschuer J, Eberl S, Bye P, Mellis C, Alison J. "Effects of exercise and PEP on mucociliary clearance in adults with cystic fibrosis". 9th Australasian Cystic Fibrosis Conference, Melbourne, Australia. 2011:p15-16.

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

Contacts
Principal investigator
Name 28616 0
Prof Jennifer Alison
Address 28616 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
East Street
Lidcombe NSW 2141
Country 28616 0
Australia
Phone 28616 0
+61 2 93519371
Fax 28616 0
Email 28616 0
jennifer.alison@sydney.edu.au
Contact person for public queries
Name 11773 0
Prof Jennifer Alison
Address 11773 0
Head of Discipline
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 11773 0
Australia
Phone 11773 0
(02) 9351 9371
Fax 11773 0
Email 11773 0
jennifer.alison@sydney.edu.au
Contact person for scientific queries
Name 2701 0
Prof Jennifer Alison
Address 2701 0
Head of Discipline
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 2701 0
Australia
Phone 2701 0
(02) 9351 9371
Fax 2701 0
Email 2701 0
jennifer.alison@sydney.edu.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
SourceTitleYear of PublicationDOI
EmbaseEffects of exercise and airway clearance (positive expiratory pressure) on mucus clearance in cystic fibrosis: A randomised crossover trial.2019https://dx.doi.org/10.1183/13993003.01793-2018
N.B. These documents automatically identified may not have been verified by the study sponsor.