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Trial registered on ANZCTR
Registration number
ACTRN12609000472279
Ethics application status
Approved
Date submitted
11/05/2009
Date registered
17/06/2009
Date last updated
17/06/2009
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of a walking training program on quality of life and exercise capacity in patients with chronic obstructive pulmonary disease.
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Scientific title
Evaluation of a walking training program versus usual care on quality of life and exercise capacity in patients with chronic obstructive pulmonary disease.
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Universal Trial Number (UTN)
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Trial acronym
WAFT Trial (Walk and Feedback Training Trial)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
237091
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1A- Subjects that are randomised to the Walk Group (WG) or Walk Feedback Group (WFG) will attend a Pulmonary Rehabiltation program, 3 times a week for 8 weeks. They will complete overground walking training only, supervised by a physiotherapist. This will start at 30 minutes and will be progressed by 5 minutes every 6th session until a maximum of 45 minutes is reached.
Trial 1B -Following the completion of the supervised walking training, both the WG and the WFG subjects will be asked to complete a further 12 months of home-based training. Subjects will receive a package comprising written instructions to walk for 45 minutes, with rests as necceasry on at least 3 days each week, a scoring system for self assessment of breathlessness and effort, and a weekly diary card to record the number of days of walking trianing each week and the total number of minutes walked each week. In addition the WFG will be given a pedometer to use during the home based training with further instrcutions to walk a minimum number of steps on at least 3 days each week whilst still achieving the duration of 45 minutes. The WFG will be contacted by telephone every 2 weeks for the first 3 months and their exercise training will be adjusted according to the number of steps achieved in the immediate past two training sessions. In the 3 to 12 month period, telephone contact will be made every month and training adjusted as above
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Intervention code [1]
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Rehabilitation
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Comparator / control treatment
1A: Participants medical management will be optimised at baseline in accordance with the Australian and New Zealand guidelines for the management of Chronic Obstructive Pulmonary Disease (COPDx plan). This will include an individualised COPD action plan, from the Australian Lung Foundation templaate, that will describe medication use when stable and during an exacerbation. Medication use will vary on a case by case basis. This group will not perform any exercise taining.
1B: Particpants receive a package comprising written instructions to walk for 45 minutes on at least 3 days each week, a scoring system for self assessment of breathlessness and effort, and a weekly diary card to record the number of days of walking trianing each week and the total number of minutes walked each week
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Control group
Active
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Outcomes
Primary outcome [1]
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Quality of Life using the Chronic Respiratory Disease Questionnaire and the St George's Respiratory Questionnaire
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Assessment method [1]
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Timepoint [1]
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1A: At baseline and at 2 months post randomisation
1B: At 8 months and 14 months post randomisaton
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Secondary outcome [1]
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Physical Activity Levels using the SenseWear Pro3 armband. This device provides information on activity intensity and duration as well as number of steps taken. Subjects will wear the device for 7 days and 7 nights, removed only for washing or swimming.
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Assessment method [1]
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Timepoint [1]
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1A: At baseline and at 2 months post randomisation
1B: At 8 months and 14 months post randomisaton
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Secondary outcome [2]
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Exercise capacity measured by the Six minute walk test, the Incremental shuttle walk test and the Endurance shuttle walk test
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Assessment method [2]
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Timepoint [2]
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1A: At baseline and at 2 months post randomisation
1B: At 8 months and 14 months post randomisaton
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Eligibility
Key inclusion criteria
Medical diagnosis of COPD; forced expiratory volume in one second (FEV1) / forced vital capacity ratio of <0.7; FEV1 of 20% to 80% predicted normal, and a smoking history more than 10 pack years (1 pack year = 20 cigarettes a day for 1 year).
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Musculoskeletal, cardiovascular or neurological conditions likely to adversely affect performance in assessments or training; or participation in supervised exercise training within the last 12 months
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone through National Health and Medical Research Council (NHMRC) interactive voice response system (IVRS)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified Allocation. Six minute walk test <70% predicted; FEV1 <40% predicted; St George's respiratory questionnaire <45; trial centre
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
19/05/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
165
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
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2050
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Recruitment postcode(s) [2]
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2031
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Recruitment postcode(s) [3]
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2137
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Recruitment postcode(s) [4]
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2138
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Recruitment postcode(s) [5]
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5118
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Recruitment postcode(s) [6]
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2034
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Recruitment postcode(s) [7]
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6163
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Recruitment postcode(s) [8]
1692
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6166
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Recruitment postcode(s) [9]
1693
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2077
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Recruitment postcode(s) [10]
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6000
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Recruitment postcode(s) [11]
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6004
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Recruitment postcode(s) [12]
1696
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6005
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Recruitment postcode(s) [13]
1697
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6006
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Recruitment postcode(s) [14]
1698
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6151
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Recruitment postcode(s) [15]
1699
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2037
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Recruitment postcode(s) [16]
1700
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2038
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Recruitment postcode(s) [17]
1701
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2042
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Recruitment postcode(s) [18]
1702
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2048
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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Director, Research Administration Section,
GPO box 1421, Canberra, ACT, 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
Clinical and Rehabilitation Sciences Faculty Research Group, Faculty of Health Sciences, University Of Sydney, NSW, 2006
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
4459
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Country [1]
4459
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney South West Area Health Service - Royal Prince Alfred Hospital Zone
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Ethics committee address [1]
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Research Development Office, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW, 2050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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28/01/2009
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Approval date [1]
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03/03/2009
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Ethics approval number [1]
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X09 - 0021 & HREC/09/RPAH/31
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Summary
Brief summary
The primary aim is to establish sound scientific evidence of the effects of ground walking training in people with COPD. The secondary aim is to evaluate whether novel feedback strategies can improve long term adherance to exercise training for people with COPD in order to gain important health benefits and markedly reduce health resource use and costs.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Miss Sally Watts
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Address
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Clinical and Rehabilitation Sciences Faculty Research Group
Faculty of Health Sciences
University Of Sydney
NSW
2006
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Country
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Australia
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Phone
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+61 2 9351 9269
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Fax
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+61 2 9351 9278
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Jennifer Alison
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Address
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Clinical and Rehabilitation Sciences Faculty Research Group
Faculty of Health Sciences
University Of Sydney
NSW
2006
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Country
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Australia
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Phone
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+61 2 9351 9371
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Fax
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+61 2 9351 9601
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Email
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[email protected]
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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
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
1. Wootton SL, Hill K, Alison JA, Ng C , Jenkins S...
[
More Details
]
83911-(Uploaded-10-03-2019-21-01-13)-Journal results publication.pdf
Study results article
Yes
Wootton SL, Ng C, McKeough ZJ, Jenkins S, Hill K, ...
[
More Details
]
83911-(Uploaded-10-03-2019-21-02-54)-Journal results publication.pdf
Study results article
Yes
ton SL, Hill K, Alison JA, Ng C , Jenkins S, Eastw...
[
More Details
]
83911-(Uploaded-10-03-2019-21-03-22)-Journal results publication.pdf
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Effect on health-related quality of life of ongoing feedback during a 12-month maintenance walking programme in patients with COPD: a randomized controlled trial.
2018
https://dx.doi.org/10.1111/resp.13128
Embase
Effects of Ongoing Feedback During a 12-Month Maintenance Walking Program on Daily Physical Activity in People with COPD.
2019
https://dx.doi.org/10.1007/s00408-019-00216-5
Embase
The minimal detectable difference for endurance shuttle walk test performance in people with COPD on completion of a program of high-intensity ground-based walking.
2019
https://dx.doi.org/10.1016/j.rmed.2018.11.013
N.B. These documents automatically identified may not have been verified by the study sponsor.
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