Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Commercial Road
PRAHRAN VICTORIA 3181
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
Monash Medical Centre
246 Clayton Road
CLAYTON VICTORIA 3168
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
Faculty Human Ethics Committee
Faculty of Health Sciences
Level 2
Health Sciences Building 2
La Trobe University
Bundoora VICTORIA 3086
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
Regular physical activity has many health benefits. More specifically, physical inactivity is an identified risk factor for global mortality, and can contribute to the incidence of non-communicable diseases such as obesity and heart disease. In generally healthy adults at least 150 minutes of moderate-vigorous intensity physical activity each week is required to improve cardiorespiratory fitness, bone health and reduce the risk of non-communicable diseases and depression. In individuals with CF there are no established targets for physical activity participation. Consequently, physical activity interventions are shaped around guidelines for healthy adults.

Improving and maintaining physical activity is a cornerstone of therapy for CF patients. Aerobic fitness is associated with improved survival and those with better physical fitness have better quality of life. Despite this, participation in exercise decreases with increasing perception of disease severity, with patients ascribing decreased importance and increased burden to exercise over other therapies. In previous studies of physical activity in CF, both children and adults have been found to undertake less moderate-vigorous physical activity than their healthy peers.

It is hypothesised that:

1. Physical activity decreases over time in CF and is more marked in particular sub-groups such as females and those with repeated need for intravenous (IV) antibiotics.
2. Factors such as higher baseline respiratory function, fulltime employment/study, higher fitness levels, younger age and male gender will all be associated with better long-term participation in physical activity.
3. Physical activity is decreased after respiratory exacerbation requiring IV antibiotics, and does not return to baseline after 4 weeks.
4. Decline in physical activity is associated with a more rapid decline in respiratory function over 12 months.
Trial website
Trial related presentations / publications
Cox NS, Alison JA, Button BM, Wilson JW, Morton JM & Holland AE. Physical activity participation by adults with cystic fibrosis: An observational study. Respirology. Epub online December 30 2015.

Presentations:
Cox NS, Alison JA, Button BM, Wilson JW, Morton JM & Holland AE. Simple Clinical Exercise Measures Predict Clinical Outcomes In Adults With Cystic Fibrosis. Am J Resp Crit Care Med. 2015. Vol 191: A5294.

Cox NS, Alison JA, Button BM, Wilson JW, Morton JM & Holland AE. Reduced physical activity participation is associated with increased need for hospitalisation in adults with cystic fibrosis. Journal of Cystic Fibrosis. 2014. 13 (Suppl 2) Page S19; WS9.3.

Cox NS, Alison JA, Button BM, Wilson JW, Morton J & Holland AE. Physical activity participation is associated with hospital days in adults with Cystic Fibrosis (CF). Respirology. 2014. 19 (Suppl 2) Pages 47-49.

Cox NS, Alison JA, Button BM, Wilson JW, Morton J & Holland AE. Physical inactivity predicts hospitalization in adults with Cystic Fibrosis. Pediatric Pulmonology. 2013. Suppl 36; A422.
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.