Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000439246
Ethics application status
Approved
Date submitted
4/12/2008
Date registered
11/06/2009
Date last updated
11/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The validity of field walking tests in prescribing lower limb exercise intensity in clinical rehabilitation for people with chronic obstructive pulmonary disease
Scientific title
The validity of field walking tests in prescribing lower limb exercise intensity in clinical rehabilitation for people with chronic obstructive pulmonary disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 4066 0
Condition category
Condition code
Respiratory 4273 4273 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a crossover study. Subjects are required to perform: Visit 1 - One incremental cycle test (ICT) and two 6MWTs. Visit 2 - A ten-minute constant work rate (CWR) cycle exercise prescribed from the 6MWT and a ten-minute CWR walking exercise at 80% of average speed of the better 6MWT. Visit 3 - Two incremental shuttle walk tests (ISWT). Visit 4 - A ten-minute CWR cycle exercise prescribed from the ISWTs and a ten-minute CWR walking exercise at 70% of peak speed of the better ISWT. The duration of the wash-out period between exercise periods or exercise tests is 30 minutes. Each visit will be 2-3 days apart and all testing will be completed within 2 weeks. The order of exercise testing will not be randomised because the intensities of the constant work rate (CWR) cycle and walking exercise periods need to be prescribed from the cycle and walking tests.
Intervention code [1] 3773 0
Rehabilitation
Comparator / control treatment
A prospective cross-over study in which participants are involved in exercise testing and training as described above. No comparator / control is involved
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5140 0
Primary outcome 1: Oxygen consumption (VO2)
Timepoint [1] 5140 0
Timepoint: Peak VO2 at end of the ICT and the field walking tests. Mean VO2 at end of all the CWR cycle and walking exercise
Primary outcome [2] 5141 0
Primary outcome 2: Dypsnoea/rate of perceived exertion scores using the Borg Category Ratio 10 (CR10)
Timepoint [2] 5141 0
Timepoint: at rest, at every minute during tests and exercise and at end of tests and exercise
Primary outcome [3] 5142 0
Primary outcome 3: Distance walked in metres from a six minute walk test and an incremental shuttle walk test.
Timepoint [3] 5142 0
Timepoint: at end of tests
Secondary outcome [1] 8655 0
Spirometry measures
Timepoint [1] 8655 0
Timepoint: at pre and post exercise testing

Eligibility
Key inclusion criteria
Subjects with mild to severe stable chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) <70% predicted and post bronchodilator FEV1 < 80% predicted as defined by Australian Chronic Obstructive Pulmonary Disease (COPDX) guidelines.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fever or increased sputum; hospital admission in the previous month; unable to wear a facemask due to claustrophobia; on long term oxygen therapy; cardiovascular, neurological or musculoskeletal co-morbidities that may limit exercise performance; completed pulmonary rehabilitation in the last 12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4232 0
Charities/Societies/Foundations
Name [1] 4232 0
Physiotherapy Research Foundation
Country [1] 4232 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Research Office, Main Quadrangle A14, The University of Sydney, University Place, Camperdown, NSW 2006
Country
Australia
Secondary sponsor category [1] 3819 0
None
Name [1] 3819 0
Address [1] 3819 0
Country [1] 3819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6286 0
Sydney South West Area Health Service
Ethics committee address [1] 6286 0
Ethics committee country [1] 6286 0
Australia
Date submitted for ethics approval [1] 6286 0
Approval date [1] 6286 0
14/11/2008
Ethics approval number [1] 6286 0
08/RPAH/463

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

Contacts
Principal investigator
Name 29185 0
Address 29185 0
Country 29185 0
Phone 29185 0
Fax 29185 0
Email 29185 0
Contact person for public queries
Name 12342 0
Associate Professor J.A. Alison
Address 12342 0
Faculty of Health Science, The University of Sydney, PO Box 170, Lidcombe, NSW, 1825
Country 12342 0
Australia
Phone 12342 0
+61 29351 9371
Fax 12342 0
+61 29351 9601
Email 12342 0
[email protected]
Contact person for scientific queries
Name 3270 0
Associate Professor J.A. Alison
Address 3270 0
Faculty of Health Science, The University of Sydney, PO Box 170, Lidcombe, NSW, 1825
Country 3270 0
Australia
Phone 3270 0
+61 29351 9371
Fax 3270 0
+61 29351 9601
Email 3270 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.