Trial Review

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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.
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.
Universal Trial Number (UTN)
Trial acronym
WAFT Trial (Walk and Feedback Training Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 4752 0
Condition category
Condition code
Respiratory 237091 237091 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 4526 0
Rehabilitation
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
Control group
Active

Outcomes
Primary outcome [1] 5922 0
Quality of Life using the Chronic Respiratory Disease Questionnaire and the St George's Respiratory Questionnaire
Timepoint [1] 5922 0
1A: At baseline and at 2 months post randomisation
1B: At 8 months and 14 months post randomisaton
Secondary outcome [1] 242010 0
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.
Timepoint [1] 242010 0
1A: At baseline and at 2 months post randomisation
1B: At 8 months and 14 months post randomisaton
Secondary outcome [2] 242011 0
Exercise capacity measured by the Six minute walk test, the Incremental shuttle walk test and the Endurance shuttle walk test
Timepoint [2] 242011 0
1A: At baseline and at 2 months post randomisation
1B: At 8 months and 14 months post randomisaton

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).
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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)
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1686 0
2031
Recruitment postcode(s) [2] 1690 0
2034
Recruitment postcode(s) [3] 1699 0
2037
Recruitment postcode(s) [4] 1700 0
2038
Recruitment postcode(s) [5] 1701 0
2042
Recruitment postcode(s) [6] 1702 0
2048
Recruitment postcode(s) [7] 1685 0
2050
Recruitment postcode(s) [8] 1693 0
2077
Recruitment postcode(s) [9] 1687 0
2137
Recruitment postcode(s) [10] 1688 0
2138
Recruitment postcode(s) [11] 1689 0
5118
Recruitment postcode(s) [12] 1694 0
6000
Recruitment postcode(s) [13] 1695 0
6004
Recruitment postcode(s) [14] 1696 0
6005
Recruitment postcode(s) [15] 1697 0
6006
Recruitment postcode(s) [16] 1698 0
6151
Recruitment postcode(s) [17] 1691 0
6163
Recruitment postcode(s) [18] 1692 0
6166

Funding & Sponsors
Funding source category [1] 4931 0
Government body
Name [1] 4931 0
National Health and Medical Research Council
Country [1] 4931 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Clinical and Rehabilitation Sciences Faculty Research Group, Faculty of Health Sciences, University Of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 4459 0
None
Name [1] 4459 0
Address [1] 4459 0
Country [1] 4459 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7014 0
Sydney South West Area Health Service - Royal Prince Alfred Hospital Zone
Ethics committee address [1] 7014 0
Ethics committee country [1] 7014 0
Australia
Date submitted for ethics approval [1] 7014 0
28/01/2009
Approval date [1] 7014 0
03/03/2009
Ethics approval number [1] 7014 0
X09 - 0021 & HREC/09/RPAH/31

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

Contacts
Principal investigator
Name 29590 0
Address 29590 0
Country 29590 0
Phone 29590 0
Fax 29590 0
Email 29590 0
Contact person for public queries
Name 12837 0
Miss Sally Watts
Address 12837 0
Clinical and Rehabilitation Sciences Faculty Research Group
Faculty of Health Sciences
University Of Sydney
NSW
2006
Country 12837 0
Australia
Phone 12837 0
+61 2 9351 9269
Fax 12837 0
+61 2 9351 9278
Email 12837 0
swatts@usyd.edu.au
Contact person for scientific queries
Name 3765 0
A/Prof Jennifer Alison
Address 3765 0
Clinical and Rehabilitation Sciences Faculty Research Group
Faculty of Health Sciences
University Of Sydney
NSW
2006
Country 3765 0
Australia
Phone 3765 0
+61 2 9351 9371
Fax 3765 0
+61 2 9351 9601
Email 3765 0
j.alison@usyd.edu.au

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect on health-related quality of life of ongoing feedback during a 12-month maintenance walking programme in patients with COPD: a randomized controlled trial.2018https://dx.doi.org/10.1111/resp.13128
EmbaseEffects of Ongoing Feedback During a 12-Month Maintenance Walking Program on Daily Physical Activity in People with COPD.2019https://dx.doi.org/10.1007/s00408-019-00216-5
EmbaseThe minimal detectable difference for endurance shuttle walk test performance in people with COPD on completion of a program of high-intensity ground-based walking.2019https://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.