Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000949088
Ethics application status
Approved
Date submitted
4/11/2010
Date registered
5/11/2010
Date last updated
25/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity in adults with Cystic Fibrosis.
Scientific title
Longitudinal assessment of physical activity in adults with Cystic Fibrosis.
Secondary ID [1] 253025 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 258586 0
Condition category
Condition code
Respiratory 258723 258723 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 258730 258730 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will assess habitual physical activity participation in adults with Cystic Fibrosis over a 12 month period. Physical activity will be assessed using a bi-axial accelerometer (Sensewear Armband [Bodymedia]). Participants will be assessed at baseline and 12 months. Measures of respiratory function, quality of life, intention to exercise and exercise capacity will be performed prior to the wearing of the activity monitor for a period of 5 to 7 days.

By measuring physical activity in this way we will be able to objectively quantify physical activity participation in adults with CF over a prolonged period. Additionally, we hope to identify the presence of clinical or demographic characteristics which determine long-term participation in physical activity; To examine the effect of a respiratory exacerbation requiring IV antibiotics on physical activity participation, as compared to baseline, in adults with CF; and, to ascertain what relationship exists between change in respiratory function and change in physical activity participation over time.
Intervention code [1] 257551 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259591 0
Time spent physically active - to be classified according to activity intensity.
Timepoint [1] 259591 0
Baseline assessment and 12 month follow-up
Secondary outcome [1] 266223 0
Spirometry measures
Timepoint [1] 266223 0
Baseline and 12 months

Eligibility
Key inclusion criteria
Diagnosis of Cystic Fibrosis
Age greater than 18 years
Able to provide informed consent
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of severe co-morbidity limiting mobilisation or physical activity participation (eg. orthopaedic, cardiac or neurological condition).
Colonization with Burkholderia cepacia.
Adults with Cystic Fibrosis who have had or are actively awaiting lung transplantation.
Respiratory exacerbation requiring intravenous antibiotics in the previous 6 weeks.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2011
Actual
3/02/2011
Date of last participant enrolment
Anticipated
Actual
6/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 3410 0
3181
Recruitment postcode(s) [2] 3411 0
3168

Funding & Sponsors
Funding source category [1] 258002 0
Government body
Name [1] 258002 0
NHMRC
Country [1] 258002 0
Australia
Primary sponsor type
Individual
Name
Narelle Cox
Address
La Trobe / Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
PRAHRAN VICTORIA 3181
Country
Australia
Secondary sponsor category [1] 257197 0
University
Name [1] 257197 0
La Trobe University
Address [1] 257197 0
c/- La Trobe / Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
Prahran VICTORIA 3181
Country [1] 257197 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259996 0
HREC The Alfred Hospital
Ethics committee address [1] 259996 0
Ethics committee country [1] 259996 0
Australia
Date submitted for ethics approval [1] 259996 0
24/11/2010
Approval date [1] 259996 0
20/12/2010
Ethics approval number [1] 259996 0
Ethics committee name [2] 259997 0
Southern Health HREC
Ethics committee address [2] 259997 0
Ethics committee country [2] 259997 0
Australia
Date submitted for ethics approval [2] 259997 0
17/11/2010
Approval date [2] 259997 0
14/12/2010
Ethics approval number [2] 259997 0
Ethics committee name [3] 259998 0
La Trobe University
Ethics committee address [3] 259998 0
Ethics committee country [3] 259998 0
Australia
Date submitted for ethics approval [3] 259998 0
03/11/2010
Approval date [3] 259998 0
Ethics approval number [3] 259998 0
25/01/2011

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

Contacts
Principal investigator
Name 31871 0
Ms Narelle Cox
Address 31871 0
La Trobe/ Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 31871 0
Australia
Phone 31871 0
+61394796871
Fax 31871 0
Email 31871 0
[email protected]
Contact person for public queries
Name 15118 0
Narelle Cox
Address 15118 0
La Trobe / Alfred Health Clinical School Level 4, The Alfred Centre 99 Commercial Road Melbourne VICTORIA 3004
Country 15118 0
Australia
Phone 15118 0
+61 3 9479 6871
Fax 15118 0
+61 3 9533 2104
Email 15118 0
[email protected]
Contact person for scientific queries
Name 6046 0
Narelle Cox
Address 6046 0
La Trobe / Alfred Health Clinical School Level 4, The Alfred Centre 99 Commercial Road Melbourne VICTORIA 3004
Country 6046 0
Australia
Phone 6046 0
+61394796871
Fax 6046 0
+61 3 9533 2104
Email 6046 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
SourceTitleYear of PublicationDOI
EmbasePhysical activity participation by adults with cystic fibrosis: An observational study.2016https://dx.doi.org/10.1111/resp.12719
N.B. These documents automatically identified may not have been verified by the study sponsor.