Trial from ANZCTR


Trial ID ACTRN12613000023752
Trial Status: Registered
Date Submitted: 8/01/2013
Date Registered: 9/01/2013
Prospectively registered

Page 1

Public title “Step up” – a pedometer based physical activity self-management program for children and adolescents with physical disability
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format “Step up” – a pedometer based physical activity self-management program for children and adolescents with physical disability
Update:
 
Reason:
 
Secondary ID [1] 281737 0
None
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym
Update:
 

Page 2

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

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Lifestyle 286274 0
Update:
 
Reason:
 
Comparator / control treatment Continue on with normal every day activities.
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

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

Page 5

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.
Update:
 
Reason:
 
Minimum age 8 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age 17 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Both males and females
Update:
 
Reason:
 
Healthy volunteers? Yes
Update:
 
Reason:
 
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.
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Educational / counselling / training
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Update:
 
Reason:
 
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation)
Update:
 
Reason:
 
Masking / blinding Open (masking not used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s)
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase
Update:
 
Reason:
 
Anticipated date of first participant enrolment 4/03/2013
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 70
Update:
 
Reason:
 
Actual sample size
Update:
 
Reason:
 
Recruitment status Not yet recruiting
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s) SA
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Charities/Societies/Foundations 286526 0
Update:
 
Reason:
 
Name: Channel 7 Children's Research Foundation 286526 0
Update:
 
Reason:
 
Address: PO Box 2438
Regency Park SA 5942
286526 0
Update:
 
Reason:
 
Country: Australia 286526 0
Update:
 
Reason:
 
Primary Sponsor University
Update:
 
Reason:
 
Name: University of South Australia
Update:
 
Reason:
 
Address: GPO Box 2471, Adelaide, SA 5001
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: Charities/Societies/Foundations 285314 0
Update:
 
Reason:
 
Name: Novita Children's Services 285314 0
Update:
 
Reason:
 
Address: 171 Days Road
Regency Park SA 5010
285314 0
Update:
 
Reason:
 
Country: Australia 285314 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: University of South Australia Human research ethics committee 288599 0
Update:
 
Reason:
 
Address: PO Box 2471, Adelaide, SA 5001 288599 0
Update:
 
Reason:
 
Country: Australia 288599 0
Update:
 
Reason:
 
Approval Date: 10/12/2012 288599 0
Update:
 
Reason:
 
Submitted Date: 288599 0
Update:
 
Reason:
 
HREC: 0000030989 288599 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

Principal Investigator
Title: Dr
Update:
 
Reason:
 
36866 0
Name: Carol Maher
Update:
 
Reason:
 
36866 0
Address: 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
Update:
 
Reason:
 
36866 0
Country: Australia
Update:
 
36866 0
Reason:
 
Tel: +61 08 8302 2315
Update:
 
Reason:
 
36866 0
Fax:
Update:
 
Reason:
 
36866 0
Email: carol.maher@unisa.edu.au
Update:
 
Reason:
 
36866 0
Contact person for public queries
Title: Dr
Update:
 
Reason:
 
36867 0
Name: Carol Maher
Update:
 
Reason:
 
36867 0
Address: 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
Update:
 
Reason:
 
36867 0
Country: Australia
Update:
 
36867 0
Reason:
 
Tel: +61 08 8302 2315
Update:
 
Reason:
 
36867 0
Fax:
Update:
 
Reason:
 
36867 0
Email: carol.maher@unisa.edu.au
Update:
 
Reason:
 
36867 0

Contact person for scientific queries
Title: Dr
Update:
 
Reason:
 
36868 0
Name: Carol Maher
Update:
 
Reason:
 
36868 0
Address: 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
Update:
 
Reason:
 
36868 0
Country: Australia
Update:
 
36868 0
Reason:
 
Tel: +61 08 8302 2315
Update:
 
Reason:
 
36868 0
Fax:
Update:
 
Reason:
 
36868 0
Email: carol.maher@unisa.edu.au
Update:
 
Reason:
 
36868 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
36869 0
Name:
Update:
 
Reason:
 
36869 0
Address:
Update:
 
Reason:
 
36869 0
Country:
Update:
 
36869 0
Reason:
 
Tel:
Update:
 
Reason:
 
36869 0
Fax:
Update:
 
Reason:
 
36869 0
Email:
Update:
 
Reason:
 
36869 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: