Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000645055
Ethics application status
Approved
Date submitted
5/08/2010
Date registered
9/08/2010
Date last updated
24/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
ProActive-Lifestyles Cerebral Palsy: Promotion of Healthy Lifestyles in Adolescents with Cerebral Palsy- A Randomised Clinical Trial.
Scientific title
Efficacy of a Disability Specific, Community Based Intervention for the Promotion of Physical Activity in Adolescents with Cerebral Palsy- A Randomised Clinical Trial- A Randomised Clinical Trial.
Secondary ID [1] 252384 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 257896 0
Condition category
Condition code
Neurological 258057 258057 0 0
Other neurological disorders
Public Health 258070 258070 0 0
Health promotion/education
Physical Medicine / Rehabilitation 258071 258071 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention aims to promote physical activity in adolescents with cerebral palsy. Participants will be randomly to either a physical activity intervention or a healthy lifestyle intervention. Both the physical activity intervention and the healthy behaviour intervention will comprise of 9 face-to-face session delivered over three months. Both intervention programs will be delivered by an exercise physiologist accredited with the Exercise & Sports Science Australia (ESSA), the recognised professional association for people with a university qualification in exercise and sports science in Australia.

The physical activity intervention utilises a range of individually tailored, evidence based strategies that aim to transition individuals through the first three stages of change – pre-contemplation, contemplation and preparation (Prochaska and Velicer 1997). One of the principal strategies used will be motivational interviewing, which focuses on enhancing the intrinsic motivation of the individual for change by exploring and resolving ambivalence, in order to promote natural change (Emmons and Rollnick 2001). This process will be facilitated by influencing factors related to behaviour change including the; knowledge underlying the behaviour; value of the behaviour; perceived costs and benefits of the behaviour; barriers to change and beliefs regarding the participant’s ability to perform the behaviour (Bundy 2004).

In addition to motivational interviewing the intervention uses other evidence based strategies in order to facilitate and support change. The selection of these strategies is determined by the stage of change (i.e. precontemplation, contemplation and preparation) that the participant is determined to be in based on the stage of change algorithm. The use of other evidence based strategies including using diaries, building social support and goal setting are not specific to any stage of change. The use of these strategies is determined by the information gained in the preparticipation screening and initial strategies (e.g. the participant may choose the “the activities I enjoy doing are with my friends” value card which indicates that social support may be a strategy). The evidence based strategies of primary importance to this intervention include; the Leisure Diagnostic Battery (Ellis and Witt 1994), diaries and log books, measuring activity levels with a pedometer, goals setting, rewards systems and social support.
Intervention code [1] 256947 0
Behaviour
Intervention code [2] 256961 0
Lifestyle
Intervention code [3] 256962 0
Other interventions
Comparator / control treatment
The control intervention for this study will comprise of a series of discussions regarding oral health, sun safety and sleep. This intervention will be facilitated by an Exercise Physiologist accredited with the Exercise & Sports Science Australia (ESSA), the recognised professional association for people with a university qualification in exercise and sports science in Australia. The Healthy Behaviour Intervention will be delivered in 9 face-to-face sessions, over three months, in the participant’s home. These behaviours were chosen due to their particular importance to adolescents and because they are not likely to lead to increased participation in physical activity. The participants will take part in a series of activities including information sessions, evaluation of current health promotional materials and questionnaires to evaluate their current behaviour and diaries to monitor their behaviour. These activities will be undertaken not to criticise the adolescent’s current behaviour or attempt to gain a commitment to behaviour change, but to 1) discuss the participant’s thoughts and feelings regarding the behaviour 2) discuss the perceived importance of these behaviours for adolescents with cerebral palsy 3) Discuss their current engagement in the health behaviour 4) Investigate and discuss goals and strategies for increasing their engagement in the health behaviour.
Control group
Active

Outcomes
Primary outcome [1] 258918 0
Physical activity will be measured using an ActiGraph (GT3X) (Clanchy et al. 2009).
- Physical activity (counts)
- Time spent in moderate intensity physical activity
- Time spent sedentary

Cut points to use:
- Sedentary 0-25 counts per 15 seconds*
- Light intensity physical activity 26-573 counts per 15 seconds*
- Moderate to vigorous intensity physical activity < 574 counts per 15 seconds*

Evenson, K.R., Catellier, D.J., Gill, K., Ondrak., K.S & McMurray, R.G., (2008) Calibration of Two Objective Measures of Physical Activity for Children. Journal of Sports Sciences; 26 (14): 1557-1565
Timepoint [1] 258918 0
Timepoint- baseline, post intervention, 3 months follow up.
Secondary outcome [1] 265081 0
Body Structures and Functions:
Quality of Life- Cerebral Palsy Quality of Life Scale (CPQOL) (Waters et al. 2007).
Timepoint [1] 265081 0
Timepoint- baseline, post intervention, 3 months follow up.
Secondary outcome [2] 265082 0
Activity:
Physical Capacity- Shuttle Run Test (Verschuren et al. 2006).
Timepoint [2] 265082 0
Timepoint- baseline, post intervention, 3 months follow up.
Secondary outcome [3] 265083 0
Participation:
Participation- Children's Activity, Participant and Enjoyment Scale (CAPE) (King et al. 2006).
Timepoint [3] 265083 0
Timepoint- baseline, post intervention, 3 months follow up.
Secondary outcome [4] 265084 0
Environmental Factors:
Craig Hospital Inventory of Environmental Factors (Harrison-Felix 2001).
Timepoint [4] 265084 0
Timepoint- baseline, post intervention, 3 months follow up.
Secondary outcome [5] 265085 0
Personal Factors:
Self Efficacy- 5 question, 5 point likert scale (Marcus et al. 1992b).
Timepoint- baseline, post intervention, 3 months follow up.
Social Support- 13 question, 6 point likert scale (Sallis et al. 1987).
Timepoint- baseline, post intervention, 3 months follow up.
Stage of Change Logarithm (Courneya 1995).
Timepoint- baseline, post intervention, 3 months follow up.
Decisional Balance- 16 question, 5 point likert scale (Marcus et al. 1992a).
Timepoint [5] 265085 0
Timepoint- baseline, post intervention, 3 months follow up.

Eligibility
Key inclusion criteria
Adolescents 10-16 years of age
Medically confirmed diagnosis of Cerebral Palsy
Living within 100km of the University of Queensland, Brisbane, Australia.
Cognitive ability commensurate to participating in a physical activity program.
Gross Motor Classification Scale rating I-III (the ability to ambulate with or without aids).
Physically inactive (Stage of Change Classification 1-3).
- Stage of Change Level 1- not completing at least 3 x 20 minute sessions of moderate intensity physical activity per week and has no intention of being physically active.
- Stage of Change Level 2- not completing at least 3 x 20 minute sessions of moderate intensity physical activity per week but would like to be physically active.
- Stage of Change Level 3- is completing some physical activity, however not on a regular basis.
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intramuscular Botulinum toxin A (BoNTA) to the lower limbs in the 6 months prior to study entry.
Surgery on lower limbs in the last 12 months.

(This study recruits at a number of different time-points, a participant who is not eligible initially may be eligible for enrolment at a later stage in the study).

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)
Participants will be offered the opportunity of enrolling in a study which aims to understand the thoughts and feeling of adolescents with cerebral palsy towards four health behaviours- physical activity, oral health, sun safety and sleep. Participants in the physical activity group will be offered the materials regarding sleep, oral health and sun safety. Likewise participants in the control group will be offered an abridged version of the physical activity intervention. Participants will be enrolled in the study as they volunteer. Informed consent will be gained from both the participant and their parent and legal guardian through age appropriate materials and a verbal explanation of the intervention procedure.

Participants will be screened for health conditions that contraindicate participation in a physical activity intervention. At the time of recruitment the participants Gross Motor Function Classification Scale (GMFCS) and Stage of Change (SOC) will be assessed. Based on their GMFCS rating and SOC score they will be allocated a score. This score determines their allocation to the treatment or health behaviour intervention. The allocation of the participant to a group will be completed independently of the person who assess their eligibility. This process is completed once the participants eligibility for the study has been confirmed.

The maximum case load that can be managed is 8, so when the first 8 participants are enrolled, their intervention will commence. The second lot of 8 participants will commence their intervention after the first finish theirs. This will continue until 5 groups of 8 participants have been through the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to the intervention and control group using minimisation by allocation. In minimisation by allocation, the important prognostic factors (in this study Stage of Change and Gross Motor Classification Level) are identified before the study starts and the allocation of a new participant to the treatment group is determined so as to minimise the difference between the groups in terms of those factors (Taves 1974). This method aims to ensure that the intervention and control groups are balanced with respect to predefined factors, as well as for the number of patients in each group.

The first participant enrolled in the study will be randomly allocated to the intervention and control group randomly by flipping a coin. Each subsequent participant will be allocated to the control or intervention group based on the allocation that will lead to a better balance between the groups for the variables of interest. This is achieved by allocating the participant to the group with the smallest total. If the total for the groups is equal, the participant will be randomly assigned to the intervention or the control group, once again by flipping a coin. After the current participant is allocated to the intervention or control group, the totals for each group are updated and the process is repeated for subsequent participants. The order to which participants are allocated within their group of eight will be decided randomly but drawing position slots.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The eligibility of the subject for the study will be determined by the principle researcher of the study. The participant will undergo a baseline assessment to gather the information that is required in order to determine allocation. Post baseline data collection, the participant will be allocated to either the physical activity intervention or the healthy lifestyle intervention. This allocation will be undertaken by a researcher external to the assessor.

The first participant enrolled in the study will be allocated to the intervention or control group randomly by flipping a coin. Each subsequent participant will be allocated to the control or intervention group based on the allocation that will lead to a better balance between the scores of the participants for the variables of interest. This is achieved by allocating the participant to the group with the smallest score. If the total for the groups is equal, the participant will be randomly assigned to the intervention or the control group, once again by flipping a coin. After the current participant is allocated to the intervention or control group, the totals for each group are updated and the process is repeated for subsequent participants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The study was conducted as a pilot in order to gain information to inform a larger scale project.
Date of first participant enrolment
Anticipated
1/07/2010
Actual
1/07/2010
Date of last participant enrolment
Anticipated
1/07/2011
Actual
1/07/2011
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
40
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 3123 0
East- from 4000 to 4157
Recruitment postcode(s) [2] 3121 0
North- from 4000 to 4560
Recruitment postcode(s) [3] 3122 0
South- from 4000 to 4280
Recruitment postcode(s) [4] 3124 0
West- from 4000 to 4305

Funding & Sponsors
Funding source category [1] 257401 0
Self funded/Unfunded
Name [1] 257401 0
The study will be funded by the students PhD fund (Kelly Clanchy).
Country [1] 257401 0
Australia
Primary sponsor type
University
Name
The study will be funded by the students PhD fund (Kelly Clanchy).
Address
School of Human Movement Studies,
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 256633 0
None
Name [1] 256633 0
Address [1] 256633 0
Country [1] 256633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259423 0
The University of Queensland Medical Research Ethic Committee
Ethics committee address [1] 259423 0
School Of Human Movement Studies,
University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 259423 0
Australia
Date submitted for ethics approval [1] 259423 0
15/12/2008
Approval date [1] 259423 0
15/01/2009
Ethics approval number [1] 259423 0
HMS09/1501
Ethics committee name [2] 259424 0
Royal Children's Hospital and Health Service District Ethics Committee
Ethics committee address [2] 259424 0
Level 3, Foundation Building
Royal Children's Hospital & Health Service District
HERSTON QLD 4029
Ethics committee country [2] 259424 0
Australia
Date submitted for ethics approval [2] 259424 0
15/11/2008
Approval date [2] 259424 0
02/12/2008
Ethics approval number [2] 259424 0
Ethics committee name [3] 259425 0
Cerebral Palsy League of Queensland Ethics Committee
Ethics committee address [3] 259425 0
P.O.Box 386
Fortitude Valley QLD 4006
Ethics committee country [3] 259425 0
Australia
Date submitted for ethics approval [3] 259425 0
15/11/2008
Approval date [3] 259425 0
16/02/2009
Ethics approval number [3] 259425 0
CPLQ Nov 2008/2009 1025
Ethics committee name [4] 259426 0
Department of Education, Training and the Arts
Ethics committee address [4] 259426 0
Strategic Policy and Performance
Level 21 Education House
30 Mary Street,
Brisbane QLD 4000

P.O.Box 15033 City East,
QLD 4002
Ethics committee country [4] 259426 0
Australia
Date submitted for ethics approval [4] 259426 0
15/11/2008
Approval date [4] 259426 0
10/02/2009
Ethics approval number [4] 259426 0
550/781

Summary
Brief summary
Current cross sectional studies indicate that adolescents with CP perform on average significantly less PA, at a lower intensity, than typically developing adolescents, for all time periods of the week, including during structured physical activity classes (van den Berg-Emons et al. 1995; Bjornson et al. 2007; Maher et al. 2007). A study by Bjornson (2007) indicates that youth with cerebral palsy record on average 2000 steps less per day than youth who are developing typically (Bjornson et al. 2007). Due to these factors the promotion of PA in children and adolescents with CP has become a public health priority (Hogan et al. 2000).

To date, there have been no studies evaluating the efficacy of a community based intervention for the promotion of physical activity in adolescents with cerebral palsy. This study aims to evaluate the efficacy of a novel, stage matched; community based intervention for; increasing habitual physical activity (HPA) counts (measured by the ActiGraph); increasing time spent in moderate intensity physical activity and; decreasing time spent sedentary in adolescents with cerebral palsy. The second aim of this study is to evaluate whether the novel stage matched, community based intervention increases; perceived quality of life; physical capacity; participation in life situations and self efficacy in adolescents with cerebral palsy. Finally this study aims to qualitatively evaluate the participants and parents/guardians perceived effectiveness and acceptability of a stage matched, community based intervention. In order to evaluate the efficacy of this intervention, the intervention will be compared to a health behaviour intervention comprising of oral health, sun safety and sleep.

Participants enrolled in the intervention will be told that they are participating in a program that aims to investigate their thoughts and feelings regarding four health behaviours; physical activity, sun safety, oral health and sleep. All of the activities and discussions undertaken in the intervention will be introduced and facilitated based on this premise. This technique was chosen in order to facilitate discussion regarding physical activity without pushing the participant to discuss directly, or commit to, change. Parents will be informed that this type of discussion can lead to behaviour change.
Trial website
n/a
Trial related presentations / publications
“Promotion of Physical Activity in Cerebral Palsy.”
Cerebral Palsy Health Inservice
Royal Children’s Hospital, Brisbane, Australia.

“ProActive Lifestyles CP- Promoting Physical Activity in Cerebral Palsy.”
Research Colloquium- Queensland Paediatric Rehabilitation Service, Brisbane, Australia.

Clanchy K, Tweedy S, Boyd RN, Trost S (2009) Validation of accelerometry for physical activity measurement in ambulant adolescents with cerebral palsy. Developmental Medicine & Child Neurology 51 (Supp 5):33
Public notes

Contacts
Principal investigator
Name 31480 0
Miss Kelly Clanchy
Address 31480 0
C/- School of Science and Technology
University of New England,
Armidale NSW 2350
Country 31480 0
Australia
Phone 31480 0
+61 2 67733083
Fax 31480 0
+61 2 67735011
Email 31480 0
kclanch2@une.edu.au
Contact person for public queries
Name 14727 0
Miss Kelly Clanchy
Address 14727 0
C/- School of Science and Technology
University of New England,
Armidale NSW 2350
Country 14727 0
Australia
Phone 14727 0
+61 2 67733083
Fax 14727 0
+61 2 67735011
Email 14727 0
kclanch2@une.edu.au
Contact person for scientific queries
Name 5655 0
Miss Kelly Clanchy
Address 5655 0
C/- School of Science and Technology
University of New England,
Armidale NSW 2350
Country 5655 0
Australia
Phone 5655 0
+61 2 67733083
Fax 5655 0
+61 2 67735011
Email 5655 0
kclanch2@une.edu.au

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