Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000010291
Ethics application status
Approved
Date submitted
16/12/2008
Date registered
7/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An internet program to improve physical activity in teenagers with cerebral palsy – Are you kidding??
Scientific title
A randomized controlled trial to test an internet-based program aimed at improving
physical activity behaviours in adolescents with cerebral palsy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 4137 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4337 4337 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 4338 4338 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group members used of a physical activity self-management program delivered via the internet. The intervention program was branded "Get Set" and was developed as an eight module, highly interactive internet program based upon social cognitive theory, incorporating education, quizzes, goal-setting, self-reflection and positive role-modelling. Modules were released weekly onto the Get Set website. Intervention group participants received a one-on-one introduction to the Get Set website prior to commencement of the program, and were encouraged to log in at least weekly for the program’s eight week duration.
Intervention code [1] 3848 0
Behaviour
Comparator / control treatment
Control group participants were encouraged to continue their normal activities. At the end of the 20 week randomised controlled trial, control participants were offered the opportunity to undertake the intervention.
Control group
Active

Outcomes
Primary outcome [1] 5221 0
physical activity behaviour (pedometer step counts)
Timepoint [1] 5221 0
baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)
Secondary outcome [1] 8796 0
exercise knowledge was assessed using a ten-item multiple choice questionnaire which was purpose developed for the study
Timepoint [1] 8796 0
baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)
Secondary outcome [2] 8797 0
self-reported exercise self-efficacy was assessed using the 8-item LEAP II exercise self-efficacy scale
Timepoint [2] 8797 0
baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)
Secondary outcome [3] 8798 0
self-reported exercise attitude was assessed using the 8-item LEAP II exercise attitude scale
Timepoint [3] 8798 0
baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)
Secondary outcome [4] 8799 0
self-reported exercise intention was assessed using the 4-item LEAP II exercise intention scale
Timepoint [4] 8799 0
baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)
Secondary outcome [5] 8800 0
functional capacity was measured using the six minute walk test. The six minute walk test is a simple, sub-maximal, clinical exercise test, in which the distance walked under controlled conditions in six minutes is measured.
Timepoint [5] 8800 0
baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)
Secondary outcome [6] 8801 0
self-reported physical activity behaviour was measured using the Multimedia Activity Recall for Children and Adolescents (MARCA). This is a computer-based, self-report tool that records young people's use of time in a 24 hour period. It was administered by phone interviews.
Timepoint [6] 8801 0
baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)

Eligibility
Key inclusion criteria
ambulant cerebral palsy
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
attending a special school (special schools are government schools that cater for children with intellectual disability, including those with concurring physical disability. They are segregated from mainstream schools.).

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 were recruited via Novita Children’s Services, the sole provider of community-based therapy, equipment, and support services to children with physical disabilities in South Australia. They were sent a letter describing the study and inviting them to participate. Once eligibility and participation in the study was confirmed, participants were matched for Gross Motor Function Classification System (GMFCS) level (the single most important determinant of physical activity level in this population) and randomly assigned to intervention or control groups. Allocation was concealed, since recruitment of the entire cohort of participants was completed prior to any subjects being allocated to groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant's name was recorded on a card and these were then sorted into three gross motor function categories (based on the severity of their cerebral palsy). Cards from each category were then placed face down and shuffled. Two names were drawn at a time to create random pairs of participants from the same gross motor function category. A coin toss was then used to randomly assign one person from each pair into the intervention group (internet-program), with the remaining person going into the control group (usual care). This process was completed for each gross motor function category. Where
there was an odd number of participants in a gross motor function category, a coin toss determined the group allocation of the lone participant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
41
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4306 0
Charities/Societies/Foundations
Name [1] 4306 0
Cerebral Palsy Foundation of Australia
Country [1] 4306 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Street address:
City East Campus
North Terrace (no street number)
Adelaide, SA 5000
Postal address:
GPO Box 2471
Adelaide 5001 SA
Country
Australia
Secondary sponsor category [1] 3878 0
None
Name [1] 3878 0
Address [1] 3878 0
Country [1] 3878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6353 0
University of South Australia Human Research Ethics Committee (UniSAHREC)
Ethics committee address [1] 6353 0
Vicki Allen
Chair UniSAHREC
Research and Innovation Services
GP2-09
Mawson Lakes Campus
University of South Australia
GPO Box 2471
Adelaide, SA 5001
Ethics committee country [1] 6353 0
Australia
Date submitted for ethics approval [1] 6353 0
01/11/2006
Approval date [1] 6353 0
23/11/2006
Ethics approval number [1] 6353 0
P248/06

Summary
Brief summary
Aim: To determine whether an online interactive intervention can improve physical activity and related behaviors in adolescents with cerebral palsy.
Methods: Adolescents (11-17 year old) with cerebral palsy were recruited to this randomised controlled trial. Intervention participants used an 8-week online physical activity self-management program which incorporated education, self-reflection, goal setting and positive role modelling. Blinded assessments were undertaken at baseline, 10 weeks and 20 weeks. Outcomes included exercise knowledge, attitudes, intention and self-efficacy scales; self-reported physical and sedentary activity; objective physical activity; and functional capacity.
Results: 41 adolescents (mean age 13y 7m: Standard Deviation 1y 8m; males n=26) participated. At the 10-week follow-up, the intervention group showed favourable changes (relative to the control group) approaching statistical significance for exercise knowledge (effect size 0.56, p=0.08) and physical activity behaviour as measured by pedometer (weekly step counts effect size 0.56, p=0.06; weekly moderate-to-vigorous physical activity effect size 0.50, p=0.06; weekly distance effect size 0.96, p=0.05). At the 20-week follow-up similar trends for change were observed but the effect sizes had weakened, suggesting a washout effect.
Interpretation: Given the encouraging trends for change, interactive online programs may offer an effective alternative for participants unable to attend face-to-face programs.
Trial website
Trial related presentations / publications
Maher, CA, Williams, MT & Olds, TS 2008, „The six-minute walk test for children with cerebral palsy?, International Journal of Rehabilitation Research, vol 31, pp. 185-188.
Maher, C, Williams, M, Olds, T & Lane, A 2007, „Using the internet to increase physical activity in teenagers with cerebral palsy – are you kidding?! Part 1 – Program usability testing?, in Proceedings of the Sixth National Physical Activity Conference, Adelaide, Australia, 13-16 October. Maher, C, Williams, M, Olds, T & Lane, A 2007, „Using the internet to increase physical activity in teenagers with cerebral palsy – are you kidding?! Part 2 – Randomised controlled trial?, in Proceedings of the Sixth National Physical Activity Conference, Adelaide, Australia, 13-16 October.
Maher, C, Williams, M, Olds, T & Lane, A 2008, „Can an internet self-management program increase physical activity in teenagers with cerebral palsy? – a randomised controlled trial?, in Proceedings of the Australasian Academy of Cerebral Palsy and Developmental Medicine Biennial Conference, Adelaide, Australia, 10-12 March.
Public notes

Contacts
Principal investigator
Name 35045 0
Address 35045 0
Country 35045 0
Phone 35045 0
Fax 35045 0
Email 35045 0
Contact person for public queries
Name 12392 0
Carol Maher
Address 12392 0
Centre for Applied Anthropometry
C7-42
City East Campus
University of South Australia
GPO Box 2471
Adelaide, SA 5001
Country 12392 0
Australia
Phone 12392 0
+6 8 8302 1741
Fax 12392 0
Email 12392 0
[email protected]
Contact person for scientific queries
Name 3320 0
Carol Maher
Address 3320 0
Centre for Applied Anthropometry
C7-42
City East Campus
University of South Australia
GPO Box 2471
Adelaide, SA 5001
Country 3320 0
Australia
Phone 3320 0
+6 8 8302 1741
Fax 3320 0
Email 3320 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
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