The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000823976
Ethics application status
Approved
Date submitted
4/08/2011
Date registered
4/08/2011
Date last updated
25/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fitness in specialist schools: Increasing the opportunities for aerobic activity in young people with cerebral palsy, a pilot randomised controlled trial.
Scientific title
Assessing the feasibility and the effect on health outcomes of a specialist school based aerobic training intervention for young people with cerebral palsy: A pilot randomised controlled trial.
Secondary ID [1] 262777 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy. 267928 0
Reduced levels of habitual physical activity. 267929 0
Reduced levels of aerobic fitness. 270485 0
Condition category
Condition code
Neurological 268070 268070 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 268071 268071 0 0
Physiotherapy
Public Health 270642 270642 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to develop a model for promoting and supporting children and adolescents with cerebral palsy, who are enrolled in Victorian specialist schools, to take part in aerobic fitness enhancing activities as a part of the school curriculum.

Young people with cerebral palsy in the experimental group will complete a 9-week, three times per week aerobic exercise intervention of 30 minutes, conducted within normal school hours. The exercise program will be designed and overseen by the priniciple researcher (a physiotherapist) and the school based physiotherapists.

Aerobic activities will be tailored to each participant's level of gross motor function and will consist of alternating activities such as, walking, running, arm and leg cycling, rowing, and aerobic style moves. Participants will have their heart rates monitored throughout each session.

The aerobic sessions will be undertaken as a group, though individual assistance will be provided where necessary.
Intervention code [1] 266622 0
Treatment: Other
Intervention code [2] 267118 0
Lifestyle
Comparator / control treatment
Young people with cerebral palsy in the control group will participate in a social games and activity group, run during lunchtimes, three times weekly for 9 weeks.

A facilitator will administer the control group program, which will consist of a variety of activities such as music and song based games and fine motor tasks including arts and crafts. Activities will be adapted accordingly to suit the ages and interests of those in the control group.
Control group
Active

Outcomes
Primary outcome [1] 266814 0
The primary outcome for this phase one randomised controlled trial will be an assessment of the feasibility and acceptability of the aerobic training program, in the specialist school setting.

Throughout the intervention adherence will be measured through thorough monitoring and recording of both attendance and level of participation once present.

Safety will be monitored through the use of a log book provided to participants and their families for recording of any adverse events or physical complaints experienced outside of school hours. Comprehensive observation for adverse events by a physiotherapist will occur, through questioning of participants at each training session and review of log book.

Acceptance will be gauged through semi-structured in-depth interviews of participants in the aerobic exercise group, to gauge their experiences and attitudes toward the intervention. Teachers, therapists and parents will also be engaged in interviews post-intervention.
Timepoint [1] 266814 0
Post-intervention
Secondary outcome [1] 276435 0
Aerobic and anaerobic capacity will be assessed through:
- Submaximal treadmill test
- Muscle power sprint test
- 6 minute walk test
Timepoint [1] 276435 0
Baseline (week 0), post-intervention (week 10) and follow-up (week 20).
Secondary outcome [2] 279460 0
Habitual physical activity and levels of sedentary behaviour will be assessed through use of an accelerometer (RT3), attached to participants' waistbands and worn during all waking hours for a period of 8 days.
Timepoint [2] 279460 0
Baseline (week 0), post-intervention (week 10) and follow-up (week 20).
Secondary outcome [3] 279461 0
Participation will be measured with the Children's Assessment of Participation and Enjoyment (CAPE).
Timepoint [3] 279461 0
Baseline (week 0), post-intervention (week 10) and follow-up (week 20).
Secondary outcome [4] 279462 0
Quality of Life will be gauged by the CP QOL-Child.
Timepoint [4] 279462 0
Baseline (week 0), post-intervention (week 10) and follow-up (week 20).
Secondary outcome [5] 279463 0
Function within the school environment will be assessed with the School Function Assessment (SFA).
Timepoint [5] 279463 0
Baseline (week 0), post-intervention (week 10) and follow-up (week 20).

Eligibility
Key inclusion criteria
Participants must be aged between 8-18 years, be able to follow simple instruction in English, and have a reliable yes/no response. Participants must be classified as between levels I-III on the Gross Motor Function Classification System (GMFCS) and be well enough to take part in an intensive exercise training program.
Minimum age
8 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Young people with cerebral palsy will be ineligible to participate if they have poorly controlled epilepsy, or another medical condition, if they have participated in a strength or aerobic training programme in the six months prior, or if they have received lower limb botulinum toxin injections, serial casting or orthopaedic surgery any time in the six months leading up to their commencement of the trial.

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)
Potential participants will be identified by their school physiotherapists and their parents provided with information on the study. Parents/Carers of potential participants will contact the principle researcher to clarify questions prior to signing of consent forms and enrollment in the study.

Consistent with the revised CONSORT recommendations for the conduct of parallel-group randomised trials only after the recruiter determines that a person is eligible for the study, the participant agrees to participate, they are enrolled and baseline assessment completed, will assignment to either the aerobic training or control group be made using the concealed randomisation method of opening the next envelope in the sequence. An administrative assistant who is unconnected to the study will be responsible for preparing and opening the sealed envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to either the experimental or control group using a concealed allocation, block randomisation method. The block randomisation method will ensure approximately equal numbers in each group and is a suitable randomisation process for randomised controlled trials with relatively small samples. The order of the blocks will be generated from a random number table and assignments sealed in sequentially numbered opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 269599 0
Charities/Societies/Foundations
Name [1] 269599 0
Windermere Foundation Ltd
Address [1] 269599 0
GPO Box 4377
Melbourne
Victoria, 3001
Country [1] 269599 0
Australia
Primary sponsor type
Individual
Name
Ms Stacey Carlon
Address
Department of Physiotherapy
Faculty of Health Sciences
La Trobe University
Bundoora,
Victoria, 3086
Country
Australia
Secondary sponsor category [1] 266633 0
Individual
Name [1] 266633 0
Deputy Dean Karen Dodd
Address [1] 266633 0
Faculty of Health Sciences
La Trobe University
Bundoora,
Victoria, 3086
Country [1] 266633 0
Australia
Secondary sponsor category [2] 266635 0
Individual
Name [2] 266635 0
Professor Nick Taylor
Address [2] 266635 0
Department of Physiotherapy
Faculty of Health Sciences
La Trobe University
Bundoora,
Victoria, 3086
Country [2] 266635 0
Australia
Secondary sponsor category [3] 266636 0
Individual
Name [3] 266636 0
Dr Nora Shields
Address [3] 266636 0
Department of Physiotherapy
Faculty of Health Sciences
La Trobe University
Bundoora,
Victoria, 3086
Country [3] 266636 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269540 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 269540 0
La Trobe University Human Ethics Committee
La Trobe University
Bundoora,
Victoria, 3086
Ethics committee country [1] 269540 0
Australia
Date submitted for ethics approval [1] 269540 0
Approval date [1] 269540 0
21/04/2011
Ethics approval number [1] 269540 0
1/11/0008
Ethics committee name [2] 269541 0
Department of Education and Early Childhood Development
Ethics committee address [2] 269541 0
2 Treasury Place
East Melbourne,
Victoria, 3002
Ethics committee country [2] 269541 0
Australia
Date submitted for ethics approval [2] 269541 0
Approval date [2] 269541 0
24/03/2011
Ethics approval number [2] 269541 0
2011_000992

Summary
Brief summary
The physical impairments characterised by cerebral palsy, which make movement more difficult, put young people with cerebral palsy at risk of reduced habitual physical activity and increased sedentary time, the long term effects of which can include a greater risk of developing secondary health problems.

We aim to complete a high quality phase one randomised controlled trial to establish if an innovative school-based aerobic exercise programme is both realistic and feasible in the specialist school setting, as well as being effective in increasing fitness, physical activity and participation for children and adolescents with cerebral palsy.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 32587 0
Ms Stacey Carlon
Address 32587 0
Department of Physiotherapy
Faculty of Health Sciences
La Trobe University
Bundoora, 3086
Victoria
Country 32587 0
Australia
Phone 32587 0
+613 9479 5771
Fax 32587 0
Email 32587 0
S.Carlon@latrobe.edu.au
Contact person for public queries
Name 15834 0
Ms Ms Stacey Carlon
Address 15834 0
Department of Physiotherapy
Faculty of Health Sciences
La Trobe University
Bundoora,
Victoria, 3086
Country 15834 0
Australia
Phone 15834 0
+613 9479 5771
Fax 15834 0
Email 15834 0
S.Carlon@latrobe.edu.au
Contact person for scientific queries
Name 6762 0
Ms Ms Stacey Carlon
Address 6762 0
Department of Physiotherapy
Faculty of Health Sciences
La Trobe University
Bundoora,
Victoria, 3086
Country 6762 0
Australia
Phone 6762 0
+613 9479 5771
Fax 6762 0
Email 6762 0
S.Carlon@latrobe.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary