Trial Review

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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
PO Box 2471, Adelaide, SA 5001
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
Physical activity is important for physical and psychological health, as well as for maintenance of physical function and independence in young people with physical disabilities. However, people with physical disabilities have difficulty finding appropriate avenues for physical activity. This project involves the development and evaluation of a novel and feasible pedometer-based physical activity self-management program for young people with physical disability. Given its low-cost, low-touch nature, once developed, this program could be readily incorporated into ongoing clinical services.
Trial website
Trial related presentations / publications
Maher, C., Crettenden, A., Evans, K., Thiessen, M., Toohey, M., Watson, A., & Dollman, J. (2015). Fatigue is a major issue for children and adolescents with physical disabilities. Developmental Medicine & Child Neurology, 57(8), 742-747.

Maher, C., Crettenden, A., Evans, K., Thiessen, M., Toohey, M., & Dollman, J. (2014). A pedometer based physical activity self-management program for children and adolescents with physical disability–design and methods of the StepUp study. BMC pediatrics, 14(1), 31.
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
Dr 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
Dr 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

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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