Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000332224
Ethics application status
Approved
Date submitted
20/04/2009
Date registered
22/05/2009
Date last updated
5/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Do wheeled walkers increase physical activity in people with chronic obstructive pulmonary disease (COPD)?
Scientific title
In people with chronic obstructive pulmonary disease (COPD), does the use of a wheeled walker in the home and community change daily physical activity?
Secondary ID [1] 283698 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 4628 0
Condition category
Condition code
Respiratory 4927 4927 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On completion of a pulmonary rehabilitation program, participants will be randomised to either Group 1 or 2 using a computer-generated random number sequence. Following randomisation, a Research Assistant will visit the homes of all participants. Those participants randomised to Group 1 will receive a wheeled walker during the first home visit and a Research Assistant will provide standardised instructions regarding its use and encourage daily ambulation with the device. Those participants randomised to Group 2 will receive encouragement regarding daily ambulation, but no wheeled walker. Four weeks after the first home visit, participants will be provided with two devices that measure physical activity and instructed to wear the devices for 5 days. At the end of these 5 days, a Research Assistant will perform a second home visit to collect the devices and other outcome measures. Those participants randomised Group 1 will have their wheeled walker removed and those participants randomised Group 2 will have a wheeled walker issued and be provided with standardised instructions regarding its use. During this home visit, all participants will receive the same encouragement from a Research Assistant to perform daily ambulation. Four weeks later, participants will again be provided with the devices that measure physical activity and instructed to wear them for 5 days. At the end of this 5 day period, a Research Assistant will perform a third and final home visit to collect the devices and other outcome measures. The four week period of time without the wheeled walker represents the 'wash-out' period.
Intervention code [1] 4387 0
Treatment: Devices
Comparator / control treatment
At the beginning of the control period, participants will receive encouragement to ambulate during daily life. They will continue to receive usual medical care. That is, they will continue with their usual medications and see their doctor as required. This will be the same for all participants during the control period. The control period will be 5 weeks in duration (four weeks "wash-out" and one week of assessment).
Control group
Active

Outcomes
Primary outcome [1] 5775 0
Daily physical activity will be measured during the waking hours of five consecutive days using the ActivPAL and Stepwatch activity monitors. Participants will also be asked to estimate how the average amount of time they spent walking during the preceding week.
Timepoint [1] 5775 0
4-5 weeks and 9-10 weeks after enrollment
Secondary outcome [1] 241735 0
Health-related quality of life will be measured using the Chronic Respiratory Disease Questionnaire.
Timepoint [1] 241735 0
Health-related quality of life will be measured once 4-5 weeks weeks after enrollment and once 9-10 weeks after enrollment.
Secondary outcome [2] 241736 0
Fear of falling will be measured using a standardised questionnaire called the Survey of Activities and Fear of falling in the Eldery (SAFE).
Timepoint [2] 241736 0
Fear of falling will be measured once 4-5 weeks after enrollment and once 9-10 weeks after enrollment.
Secondary outcome [3] 241737 0
Wheeled walker use will be measured using a magnetic odemeter on the front wheel of the walker.
Timepoint [3] 241737 0
The number of wheel revolutions (i.e. wheeled walker use) made during the time the participant has the device will be recorded. That is, wheeled walker use will be recorded once 4-5 weeks after enrollment or once 9-10 weeks after enrollment.
Secondary outcome [4] 241738 0
Preference (with vs. without wheeled walker) will be measured using standardised questions.
Timepoint [4] 241738 0
study completion

Eligibility
Key inclusion criteria
Diagnosis of COPD
Six-minute walk distance < 450 m prior to pulmonary rehabilitation
Deemed approp for a wheeled walker by a physiotherapist
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
use of a wheeled walker for more than 2 weeks prior to commencing pulmonary rehabilitation
any co-morbid condition that limits mobility

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)
Potential participants will be identified during participation in a pulmonary rehabilitation program. Once consent is obtained, subjects will be randomly allocated to one of two groups. The randomisation sequence will be concealed using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number sequence, blocked for groups of 4, stratified according to oxygen use.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/08/2009
Actual
1/03/2010
Date of last participant enrolment
Anticipated
29/12/2011
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1800 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 1801 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 1802 0
Bentley Health Service - Bentley
Recruitment hospital [4] 1803 0
Swan Districts Hospital - Middle Swan

Funding & Sponsors
Funding source category [1] 4811 0
Hospital
Name [1] 4811 0
Sir Charles Gairdner Hospital Research Fund
Country [1] 4811 0
Australia
Primary sponsor type
Individual
Name
Dr. Sue Jenkins
Address
c/o Hospital Ave, Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 4342 0
Individual
Name [1] 4342 0
Dr. Kylie Hill
Address [1] 4342 0
c/o Hospital Ave, Nedlands, WA, 6009
Country [1] 4342 0
Australia
Secondary sponsor category [2] 4343 0
Individual
Name [2] 4343 0
Dr. Peter Eastwood
Address [2] 4343 0
c/o Hospital Ave, Nedlands, WA, 6009
Country [2] 4343 0
Australia
Secondary sponsor category [3] 4344 0
Individual
Name [3] 4344 0
Nola Cecins
Address [3] 4344 0
c/o Hospital Ave, Nedlands, WA, 6009
Country [3] 4344 0
Australia
Other collaborator category [1] 646 0
University
Name [1] 646 0
Curtin University of Technology
Address [1] 646 0
GPO Box U1987, Perth, WA, 6845
Country [1] 646 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6856 0
Sir Charles Gairdner Hospital Research Ethics Committee
Ethics committee address [1] 6856 0
Ethics committee country [1] 6856 0
Australia
Date submitted for ethics approval [1] 6856 0
10/04/2009
Approval date [1] 6856 0
Ethics approval number [1] 6856 0
Ethics committee name [2] 290265 0
South Metropolitan Area Health Service Ethics Committee
Ethics committee address [2] 290265 0
Ethics committee country [2] 290265 0
Australia
Date submitted for ethics approval [2] 290265 0
09/04/2010
Approval date [2] 290265 0
06/05/2010
Ethics approval number [2] 290265 0
S/10/192
Ethics committee name [3] 290266 0
Royal Perth Hospital Ethics Committee
Ethics committee address [3] 290266 0
Ethics committee country [3] 290266 0
Australia
Date submitted for ethics approval [3] 290266 0
26/03/2010
Approval date [3] 290266 0
23/04/2010
Ethics approval number [3] 290266 0
RA-10/007
Ethics committee name [4] 290267 0
Swan Kalamunda Health Service Ethics Committee
Ethics committee address [4] 290267 0
Ethics committee country [4] 290267 0
Australia
Date submitted for ethics approval [4] 290267 0
07/07/2010
Approval date [4] 290267 0
16/08/2010
Ethics approval number [4] 290267 0
Ref no: 032

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

Contacts
Principal investigator
Name 29508 0
Dr Kylie Hill
Address 29508 0
c/o Physiotherapy Dept, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA, 6009
Country 29508 0
Australia
Phone 29508 0
+61 8 9346 4408
Fax 29508 0
Email 29508 0
[email protected]
Contact person for public queries
Name 12755 0
Kylie Hill
Address 12755 0
c/o Physiotherapy Dept,
Sir Charles Gairdner Hospital,
Hospital Ave, Nedlands, WA, 6009
Country 12755 0
Australia
Phone 12755 0
+61 8 9346 4408
Fax 12755 0
+ 61 8 9346 3037
Email 12755 0
[email protected]
Contact person for scientific queries
Name 3683 0
Kylie Hill
Address 3683 0
c/o Physiotherapy Dept,
Sir Charles Gairdner Hospital,
Hospital Ave, Nedlands, WA, 6009
Country 3683 0
Australia
Phone 3683 0
+61 8 9346 4408
Fax 3683 0
+ 61 8 9346 3037
Email 3683 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
EmbaseEffect of Using a Wheeled Walker on Physical Activity and Sedentary Time in People with Chronic Obstructive Pulmonary Disease: A Randomised Cross-Over Trial.2020https://dx.doi.org/10.1007/s00408-019-00297-2
N.B. These documents automatically identified may not have been verified by the study sponsor.