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Trial registered on ANZCTR


Registration number
ACTRN12613000023752
Ethics application status
Approved
Date submitted
8/01/2013
Date registered
9/01/2013
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
“Step up” – a pedometer based physical activity self-management program for children and adolescents with physical disability
Scientific title
“Step up” – a pedometer based physical activity self-management program for children and adolescents with physical disability
Secondary ID [1] 281737 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical disability 288043 0
Condition category
Condition code
Public Health 288420 288420 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The “StepUp” intervention is an 6-week pedometer-based physical activity program for children with physical disabilities. It comprises
1. a 1 hr one-on-one counseling session with the participant, their parent and a Novita physiotherapist to introduce the StepUp materials,
2. a pedometer,
3. the “StepUp” booklet, which provides advice on the benefits of physical activity for children with disabilities, tips to increase physical activity specifically tailored to children with physical disabilities, and a 6-week log book to allow participants to record and track their progress. Participants will be asked to submit a copy of their step counts to the overseeing therapist weekly via mail or email.
4. 3 x fortnightly follow-up phone calls from the Novita therapist (approx. 5 minutes in duration) to provide support and answer questions.
Intervention code [1] 286274 0
Lifestyle
Comparator / control treatment
Continue on with normal every day activities.
Control group
Active

Outcomes
Primary outcome [1] 288586 0
Objective physical activity (Actigraph GT3X+ accelerometery)
Timepoint [1] 288586 0
Baseline, post-intervention (6 weeks) and 3 month follow-up
Secondary outcome [1] 300539 0
Exercise intention (LEAP II exercise intention scale)
Timepoint [1] 300539 0
Baseline, post-intervention (6 weeks) and 3 month follow-up
Secondary outcome [2] 300540 0
Physical self-worth (Physical Self-worth Scale)
Timepoint [2] 300540 0
Baseline, post-intervention and 3 month follow-up
Secondary outcome [3] 300541 0
Quality of life (KINDL)
Timepoint [3] 300541 0
Baseline, post-intervention and 3 month follow-up

Eligibility
Key inclusion criteria
1. aged 8-17 years;
2. diagnosed as having a physical disability;
3. use ambulation as their main method of transport;
4. live in greater Adelaide; and
5. have sufficient cognitive ability to understand the program.
Minimum age
8 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. use of wheelchair as main form of transport;
2. recent or planned orthopaedic surgery; and
3. injury impacting on ability to partake in physical activity.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2013
Actual
3/06/2013
Date of last participant enrolment
Anticipated
Actual
13/12/2013
Date of last data collection
Anticipated
Actual
31/03/2014
Sample size
Target
70
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286526 0
Charities/Societies/Foundations
Name [1] 286526 0
Channel 7 Children's Research Foundation
Country [1] 286526 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 285314 0
Charities/Societies/Foundations
Name [1] 285314 0
Novita Children's Services
Address [1] 285314 0
171 Days Road
Regency Park SA 5010
Country [1] 285314 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288599 0
University of South Australia Human research ethics committee
Ethics committee address [1] 288599 0
Ethics committee country [1] 288599 0
Australia
Date submitted for ethics approval [1] 288599 0
Approval date [1] 288599 0
10/12/2012
Ethics approval number [1] 288599 0
0000030989

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

Contacts
Principal investigator
Name 36866 0
Dr Carol Maher
Address 36866 0
Health and Use of Time Group, School of Health Sciences
C7-41, City East Campus, University of South Australia
GPO Box 2471, Adelaide SA 5001
Country 36866 0
Australia
Phone 36866 0
+61 08 8302 2315
Fax 36866 0
Email 36866 0
carol.maher@unisa.edu.au
Contact person for public queries
Name 36867 0
Carol Maher
Address 36867 0
Health and Use of Time Group, School of Health Sciences
C7-41, City East Campus, University of South Australia
GPO Box 2471, Adelaide SA 5001
Country 36867 0
Australia
Phone 36867 0
+61 08 8302 2315
Fax 36867 0
Email 36867 0
carol.maher@unisa.edu.au
Contact person for scientific queries
Name 36868 0
Carol Maher
Address 36868 0
Health and Use of Time Group, School of Health Sciences
C7-41, City East Campus, University of South Australia
GPO Box 2471, Adelaide SA 5001
Country 36868 0
Australia
Phone 36868 0
+61 08 8302 2315
Fax 36868 0
Email 36868 0
carol.maher@unisa.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.