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Trial registered on ANZCTR


Registration number
ACTRN12610000595011
Ethics application status
Approved
Date submitted
21/07/2010
Date registered
23/07/2010
Date last updated
23/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity levels of patients with cystic fibrosis admitted to hospital with an acute pulmonary exacerbation
Scientific title
The effect of hospitalisation with an acute pulmonary exacerbation on the physical activity levels, exercise tolerance and grip strength of patients with cystic fibrosis
Secondary ID [1] 252257 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cystic fibrosis 257773 0
Condition category
Condition code
Human Genetics and Inherited Disorders 257948 257948 0 0
Cystic fibrosis
Respiratory 257975 257975 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Physical activity levels will be measured, using a SenseWear Pro 3 Armband, for a 24 hour period between days 3 and 5 of the hospitalisation period and 1 month after discharge. A clinical exercise test, the modified shuttle walk test, will be undertaken on day 5/6 of hospitalisation and 1 month after discharge from hospital to assess exercise tolerance. The exercise tests will be undertaken at (slightly) different time points to the assessment of physical activity levels to avoid the exercise tests affecting the measurement of physical activity levels. Skeletal muscle grip strength will be measured between days 3 and 5 of the hospitalisation period and 1 month after discharge using a calibrated Jamar dynamometer. The study will continue until the required sample size (n = 34) is achieved.
Intervention code [1] 256838 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258813 0
Physical activity levels will be measured for a 24 hour period using the SenseWear Pro 3 Armband.
Timepoint [1] 258813 0
Between days 3 and 5 of hospitalisation and 1 month after discharge from hospital.
Secondary outcome [1] 264893 0
Exercise performance levels will be assessed using a performance-based test, namely, the modified shuttle walk test
Timepoint [1] 264893 0
Between days 3 and 5 of hospitalisation and 1 month after discharge from hospital.
Secondary outcome [2] 264894 0
Grip strength will be assessed using a calibrated Jamar dynamometer on setting 2
Timepoint [2] 264894 0
Between days 3 and 5 of hospitalisation and 1 month after discharge from hospital.

Eligibility
Key inclusion criteria
Adult patients with cystic fibrosis admitted to the Royal Adelaide Hospital with an acute exacerbation of their pulmonary disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are unwilling to participate or unable to commit to the 1 month follow-up measurements.

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
1/09/2010
Actual
26/10/2010
Date of last participant enrolment
Anticipated
Actual
25/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257304 0
Hospital
Name [1] 257304 0
Royal Adelaide Hospital Allied Health Research Grant
Country [1] 257304 0
Australia
Primary sponsor type
Individual
Name
Nathan Ward
Address
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000.
Country
Australia
Secondary sponsor category [1] 256546 0
Individual
Name [1] 256546 0
Dianne White
Address [1] 256546 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000.
Country [1] 256546 0
Australia
Secondary sponsor category [2] 256547 0
Individual
Name [2] 256547 0
Hilary Rowe
Address [2] 256547 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000.
Country [2] 256547 0
Australia
Secondary sponsor category [3] 256548 0
Individual
Name [3] 256548 0
Kathy Stiller
Address [3] 256548 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000.
Country [3] 256548 0
Australia
Secondary sponsor category [4] 256549 0
Individual
Name [4] 256549 0
Thomas Sullivan
Address [4] 256549 0
Data Management and Analysis Centre, Discipline of Public Health, University of Adelaide, Adelaide, SA 5005.
Country [4] 256549 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259330 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 259330 0
Research Ethics Committee, Level 3, Hanson Institute,
Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000.
Ethics committee country [1] 259330 0
Australia
Date submitted for ethics approval [1] 259330 0
Approval date [1] 259330 0
20/07/2010
Ethics approval number [1] 259330 0

Summary
Brief summary
To determine objectively how inactive cystic fibrosis patients are during and after a hospital admission for an acute pulmonary exacerbation by assessing them using a highly accurate physical activity level monitor. The study also seeks to determine whether exercise tolerance and skeletal muscle strength are reduced during periods of hospitalisation for an acute exacerbation.
Trial website
Trial related presentations / publications
Ward N, White D, Rowe H, Stiller K, Sullivan T (2013)
Physical activity levels of patients with cystic fibrosis hospitalised with an acute respiratory exacerbation. Respiratory Medicine 107:1014-1020.

Ward N, White D, Rowe H, Stiller K (2011)
Physical activity levels of adult patients with cystic fibrosis during hospitalisation for an acute respiratory exacerbation. 9th Australasian Cystic Fibrosis Conference, 2011, Melbourne, Australia.
Public notes

Contacts
Principal investigator
Name 31411 0
Mr Nathan Ward
Address 31411 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 31411 0
Australia
Phone 31411 0
61 8 82225334
Fax 31411 0
61 8 82224279
Email 31411 0
[email protected]
Contact person for public queries
Name 14658 0
Kathy Stiller
Address 14658 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000.
Country 14658 0
Australia
Phone 14658 0
+61 8 82225334
Fax 14658 0
Email 14658 0
[email protected]
Contact person for scientific queries
Name 5586 0
Kathy Stiller
Address 5586 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000.
Country 5586 0
Australia
Phone 5586 0
+61 8 82225334
Fax 5586 0
Email 5586 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.