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Trial registered on ANZCTR


Registration number
ACTRN12606000081516
Ethics application status
Approved
Date submitted
22/02/2006
Date registered
23/02/2006
Date last updated
24/02/2020
Date data sharing statement initially provided
24/02/2020
Date results information initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise and childhood TBI study- pilot
Scientific title
The effect of prescribed aerobic exercise on the recovery from traumatic brain injuries (TBI) among children and adolescents - Pilot study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 1045 0
Condition category
Condition code
Injuries and Accidents 1123 1123 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed pilot study will evaluate the effect of a prescribed aerobic exercise intervention program on levels of physical fitness, body weight, cognitive ability and quality of life among children and adolescents who have suffered from moderate and severe traumatic brain injury. The program will last for 12 weeks with 2 sessions per week according to the requirement for significant effects which have been reported in the literature
Intervention code [1] 915 0
Rehabilitation
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1499 0
Cognition/attention.

Outcome measures have been selected to assess impairment, activity and participation according to the WHO international classification of Functioning, Disability and Health (WHO, 2001). Instruments used in these assessments are all validated and standardised clinical tools that are commonly used in clinical practice.
Changes to cognition, behaviour and attention will be assessed by the Behaviour Rating Inventory of Executive Function (BRIEF, Gioia et al, 2000). The BRIEF inventory is a multidimensional questionnaire specifically designed for assessing the behaviour and cognitive status, particularly executive functions, of children and adolescents aged between 5 and 18 years. This is a fully validated and standardised instrument, and is used as standard practice for the assessment of children with TBI in the Department of Rehabilitation Medicine CHW.
Timepoint [1] 1499 0
Data will be collected on each subject at baseline, and 3 months (immediately after the intervention).
Primary outcome [2] 1500 0
Functional status.

Outcome measures have been selected to assess impairment, activity and participation according to the WHO international classification of Functioning, Disability and Health (WHO, 2001). Instruments used in these assessments are all validated and standardised clinical tools that are commonly used in clinical practice.
Functional status (ie ability to complete activities of daily living such as dressing, toileting, feeding) will be measured using the WeeFIM System (UDS MR, 1998) which is designed as a functional assessment for children and adolescents with acquired and congenital disability (UDS MR. 1998).
Timepoint [2] 1500 0
Data will be collected on each subject at baseline, and 3 months (immediately after the intervention).
Primary outcome [3] 1501 0
Mobility.

Outcome measures have been selected to assess impairment, activity and participation according to the WHO international classification of Functioning, Disability and Health (WHO, 2001). Instruments used in these assessments are all validated and standardised clinical tools that are commonly used in clinical practice.
Mobility will be assessed using a 6-minute walking and the 10 metre velocity tests which are current practice in the Rehab Department.
Timepoint [3] 1501 0
Data will be collected on each subject at baseline, and 3 months (immediately after the intervention).
Primary outcome [4] 1502 0
General quality of life.
Outcome measures have been selected to assess impairment, activity and participation according to the WHO international classification of Functioning, Disability and Health (WHO, 2001). Instruments used in these assessments are all validated and standardised clinical tools that are commonly used in clinical practice.
The health specific (but not condition specific) quality of life of patients will also be assessed by using the Child Health Questionnaire–Parent Report (CHQ-PF50, Landgraf, & Ware, 1996). In terms of the general state of physical fatigue, there is no assessment instrument currently available.
Timepoint [4] 1502 0
Data will be collected on each subject at baseline, and 3 months (immediately after the intervention).
Primary outcome [5] 1503 0
Parental evaluation on the program.
Outcome measures have been selected to assess impairment, activity and participation according to the WHO international classification of Functioning, Disability and Health (WHO, 2001). Instruments used in these assessments are all validated and standardised clinical tools that are commonly used in clinical practice.
Timepoint [5] 1503 0
Data will be collected on each subject at baseline, and 3 months (immediately after the intervention).
Secondary outcome [1] 2701 0
Physical fitness improvement. Physical fitness will be assessed using a Bruce treadmill protocol or a fixed bike riding protocol, and gas analysis using a Medgraphics metabolic cart. Values for HR peak, VO2 peak and Anaerobic Threshold will be obtained.
Timepoint [1] 2701 0
Assessed before the commencement and at the end of the intervention.
Secondary outcome [2] 2702 0
Improvements on physical activities.
Timepoint [2] 2702 0
Assessed before the commencement and at the end of the intervention.
Secondary outcome [3] 2703 0
Body weight
Timepoint [3] 2703 0
Assessed before the commencement and at the end of the intervention.

Eligibility
Key inclusion criteria
Eligible subjects of this study will include children and adolescents who have sustained moderate and severe traumatic head injuries (as determined by their initial GCS) at least 12 months prior to enrolment, and who are seen as outpatients of the Brain Injury Rehabilitation Team at Children's Hospital at Westmead.
Minimum age
5 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who are unable to participate in a prescribed exercise program due to severe physical limitations or severe cognitive disability, such as inability to walk on a treadmill or sit on an exercise bike, will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
This is a pilot phase of a full randomised control trial
Phase
Type of endpoint(s)
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)
NSW

Funding & Sponsors
Funding source category [1] 1227 0
Charities/Societies/Foundations
Name [1] 1227 0
Baxter Charitable Fund
Address [1] 1227 0
Cnr Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
Country [1] 1227 0
Australia
Primary sponsor type
Hospital
Name
The Royal Alexandra Hospital for Children
Address
Cnr Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 1084 0
Other
Name [1] 1084 0
Centre for Trauma Care, Prevention, Education, & Research
Address [1] 1084 0
NIL
Country [1] 1084 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2556 0
Children's Hospital at Westmead Ethics Committee
Ethics committee address [1] 2556 0
Cnr Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
Ethics committee country [1] 2556 0
Australia
Date submitted for ethics approval [1] 2556 0
Approval date [1] 2556 0
30/04/2006
Ethics approval number [1] 2556 0
2005/027

Summary
Brief summary
The project received ethical approval from the Children's Hospital at Westmead Ethics Committee,
Trial website
Trial related presentations / publications
Lam LT. (2008) Prescribed aerobic exercise and the recovery from traumatic brain injuries (TBI) among children and adolescents: A Randomised Controlled Trail Protocol. In: Beaulieu NP (Ed). Physical Activity and Children: New Research. New York, Hauppauge: Nova Science Publisher, pp. 241-252.
Public notes

Contacts
Principal investigator
Name 36348 0
Prof Lawrence T. Lam
Address 36348 0
Faculty of Health, University of Technology Sydney,
235 Jones St, Ultimo NSW 2007
Country 36348 0
Australia
Phone 36348 0
+61 0403 500 352
Fax 36348 0
Email 36348 0
lawrence.lam@uts.edu.au
Contact person for public queries
Name 10104 0
Prof Lawrence T. Lam
Address 10104 0
Faculty of Health, University of Technology Sydney,
235 Jones St, Ultimo NSW 2007
Country 10104 0
Australia
Phone 10104 0
+61 0403 500 352
Fax 10104 0
Email 10104 0
lawrence.lam@uts.edu.au
Contact person for scientific queries
Name 1032 0
Prof Lawrence T. Lam
Address 1032 0
Faculty of Health, University of Technology Sydney,
235 Jones St, Ultimo NSW 2007
Country 1032 0
Australia
Phone 1032 0
+61 0403 500 352
Fax 1032 0
Email 1032 0
lawrence.lam@uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 7056 0
Study protocol
Citation [1] 7056 0
Lam LT. (2008) Prescribed aerobic exercise and the recovery from traumatic brain injuries (TBI) among children and adolescents: A Randomised Controlled Trail Protocol. In: Beaulieu NP (Ed). Physical Activity and Children: New Research. New York, Hauppauge: Nova Science Publisher, pp. 241-252.
Link [1] 7056 0
Email [1] 7056 0
Other [1] 7056 0
Attachment [1] 7056 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary