Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001113842
Ethics application status
Approved
Date submitted
10/10/2012
Date registered
18/10/2012
Date last updated
8/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Walkabout: a program to increase physical activity among young adults with Down syndrome
Scientific title
Walkabout: a program to increase physical activity among young adults aged between 18 and 35 years with Down syndrome and mild to moderate intellectual disability
Secondary ID [1] 281370 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Young adults with Down syndrome 287593 0
Condition category
Condition code
Human Genetics and Inherited Disorders 287922 287922 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will complete an 8-week, mentored physical activity program called Walkabout. They will undertake to complete 150 minutes of moderate intensity physical activity per week during the program. The first 2 weeks will be a familiarisation phase, to introduce the program to the participants and allow them to adapt to the program with the aim of building up to 150 minutes of moderate activity by week 3.

Each participant will be teamed with a student mentor who will be a physiotherapy student. The participant and their mentor will complete two walking sessions together each week (each session will be 45 minutes in duration). The other 60 minutes of activity will be individually tailored to the circumstances of the participant. A planning session on how to implement these additional 60 minutes of walking without the mentor will be conducted at the start of the intervention period with a member of the research team, and a second planning session will be undertaken after 4 weeks to review progress and to make changes if necessary. All participants will receive motivational prompts (postcard reminders). The participants will wear a pedometer while they are walking to measure the number of steps completed in each session. They will also be encouraged to walk briskly. Information about the activity they do will be noted in a log-book.
Intervention code [1] 285835 0
Lifestyle
Comparator / control treatment
Participants in the control group will complete an 8-week program of social activities with a student mentor. The program will comprise social and recreational activities that would not be expected to have a fitness or training effect, such as painting, printing, music or social activities that do not incorporate a physical activity component. Each session of the social program will run for 90 minutes, equal to the time spent in the 2 mentored walking sessions each week in the intervention group. The control group participants will also receive the same level of feedback as the intervention group; they will receive postcards with simple messages similar to the motivational prompts received by the intervention group. These messages will provide information that is not intended to be motivational to increase physical activity, such as weather reports, details of a topical news story or sports results.
Control group
Active

Outcomes
Primary outcome [1] 288135 0
7-day Physical activity levels measured using accelerometry
Timepoint [1] 288135 0
At baseline (week 0), and post intervention (week 9)
Secondary outcome [1] 299479 0
Walking capacity (6 minute walk test, self-selected walking speed, fast walking speed)
Timepoint [1] 299479 0
At baseline (week 0), and post intervention (week 9)
Secondary outcome [2] 299481 0
Body structure (waist circumference, weight)
Timepoint [2] 299481 0
At baseline (week 0), and post intervention (week 9)
Secondary outcome [3] 299482 0
Perceptions of wellbeing and attitudes to physical activity (using the barriers to exercise scale, interaction with disabled persons scale and community living attitudes scale)
Timepoint [3] 299482 0
At baseline (week 0), and post intervention (week 9)

Eligibility
Key inclusion criteria
(i) Young adults with Down syndrome
(ii) Mild to moderate intellectual disability, as perceived by their parents or carers
(iii) Ability to follow simple verbal instructions in English.
(iv) Fit and well enough to participate in a physical activity program.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) Participation in a physical activity program 3 months prior to their participation in the trial,
(ii) An acute or concurrent medical condition rendering a participant unfit to participate in moderate level physical activity based on medical advice,
(iii) A significant behavioural problem that would impact on their ability to participate,

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)
Participants will be recruited to the study and undergo baseline testing before being randomly allocated to either the social or intervention group. using a concealed allocation, block randomisation method. Participants will be considered in blocks. The order of the blocks will be generated using the website randomization.org and assignments sealed in sequentially numbered opaque envelopes. Using 'randomization.org', a list of numbers from 1 to 20 will be randomly generated in 2 columns . These two columns will then represent the 'intervention' group (1st column) and 'control' group (2nd column). The relevant group name will then written on a piece of cardboard and placed in an opaque envelope with the number of the participant on the front. A researcher not involved in recruitment will allocate the participants by opening the next envelope in the sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The website randomization.org will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286123 0
University
Name [1] 286123 0
Faculty of Health Sciences, La Trobe University grant
Country [1] 286123 0
Australia
Primary sponsor type
University
Name
Faculty of Health Sciences, La Trobe University grant
Address
La Trobe University, Plenty Road, Bundoora, VIC, 3086
Country
Australia
Secondary sponsor category [1] 284937 0
None
Name [1] 284937 0
Nil
Address [1] 284937 0
Nil
Country [1] 284937 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288173 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 288173 0
Ethics committee country [1] 288173 0
Date submitted for ethics approval [1] 288173 0
Approval date [1] 288173 0
09/08/2012
Ethics approval number [1] 288173 0
12/0056

Summary
Brief summary
This randomised controlled trial will compare the effect of an 8-week mentored physical activity program called Walkabout compared with a social program for young adults with Down syndrome aged 18-35 years. Specifically, it will examine if Walkabout increases their level of physical activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34782 0
Address 34782 0
Country 34782 0
Phone 34782 0
Fax 34782 0
Email 34782 0
Contact person for public queries
Name 18029 0
Dr Nora Shields
Address 18029 0
Department of Physiotherapy
Bldg HS3, Rm 515
La Trobe University
Plenty Road
Bundoora
VIC 3086
Country 18029 0
Australia
Phone 18029 0
+61394795852
Fax 18029 0
Email 18029 0
[email protected]
Contact person for scientific queries
Name 8957 0
Dr Nora Shields
Address 8957 0
Department of Physiotherapy
Bldg HS3, Rm 515
Plenty Road
La Trobe University
Bundoora
VIC 3086
Country 8957 0
Australia
Phone 8957 0
+61394795852
Fax 8957 0
Email 8957 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.