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Trial registered on ANZCTR


Registration number
ACTRN12606000062527
Ethics application status
Approved
Date submitted
23/01/2006
Date registered
10/02/2006
Date last updated
7/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fitness training after traumatic brain injury
Scientific title
The efficacy of a supervised fitness centre-based exercise programme compared to an unsupervised home-based exercise programme on improving fitness and psychosocial outcomes in a traumatic brain injured population
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury (TBI) 1023 0
Condition category
Condition code
Injuries and Accidents 1100 1100 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-week gym-based supervised exercise programme compared to a 12-week home-based independent exercise programme,
Intervention code [1] 856 0
Rehabilitation
Comparator / control treatment
both exercise programmes consisting of strength and cardiorespiratory fitness components
Control group
Active

Outcomes
Primary outcome [1] 1467 0
Cardiorespiratory fitness measured using the modified walk/run shuttle test
Timepoint [1] 1467 0
Measured at baseline (before discharge from hospital), at the end of the intervention phase (3-months) and at the end of the follow-up phase (6-months)
Secondary outcome [1] 2632 0
Body composition measured using waist to hip ratio and body mass index.
Timepoint [1] 2632 0
These secondary measures are measured at baseline (before discharge from hospital), at the end of the intervention phase (3-months) and at the end of the follow-up phase (6-months).
Secondary outcome [2] 2633 0
Four psychosocial measures to measure depression and community integration using the DASS, POMS, BICRO-39 and SPRS.
Timepoint [2] 2633 0
These secondary measures are measured at baseline (before discharge from hospital), at the end of the intervention phase (3-months) and at the end of the follow-up phase (6-months).

Eligibility
Key inclusion criteria
1. have sustained a very severe or extremely severe TBI, 2. have had a hospital admission > 1 month, 3. able to walk independently > 1m/s, 4. able to commit 3 hours per week to exercise, 5. live within area serviced by 3 units.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. concurrent medical condition for which moderate to high intensity exercise is contraindicated, 2. have cognitive or language problems that affect their ability to understand verbal instructions, 3. have behaviour problems not appropriate for a fitness centre environment.

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)
Sealed opaque envelopes are used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocks of random computer generated numbers. The block size is variable and is in random order
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
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)

Funding & Sponsors
Funding source category [1] 1203 0
Government body
Name [1] 1203 0
Motor Accidents Authority of NSW
Address [1] 1203 0
580 George Street Sydney NSW 2000
Country [1] 1203 0
Australia
Primary sponsor type
Government body
Name
Brain Injury Rehabilitation Unit, Liverpool Health Service
Address
Elizabeth Street Liverpool NSW 1871
Country
Australia
Secondary sponsor category [1] 1062 0
University
Name [1] 1062 0
University of Sydney
Address [1] 1062 0
Faculty of Health Sciences. East Street, Lidcombe NSW 1825
Country [1] 1062 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2542 0
Brain Injury Rehabiltation Units at Liverpool
Ethics committee address [1] 2542 0
Ethics committee country [1] 2542 0
Australia
Date submitted for ethics approval [1] 2542 0
Approval date [1] 2542 0
Ethics approval number [1] 2542 0
Ethics committee name [2] 2543 0
Brain Injury Rehabiltation Units at Ryde
Ethics committee address [2] 2543 0
Ethics committee country [2] 2543 0
Australia
Date submitted for ethics approval [2] 2543 0
Approval date [2] 2543 0
Ethics approval number [2] 2543 0
Ethics committee name [3] 2544 0
Brain Injury Rehabiltation Units at Westmead
Ethics committee address [3] 2544 0
Ethics committee country [3] 2544 0
Australia
Date submitted for ethics approval [3] 2544 0
Approval date [3] 2544 0
Ethics approval number [3] 2544 0

Summary
Brief summary
The aim of this project is to compare the efficacy of a three-month supervised fitness centre-based exercise programme to an unsupervised home-based exercise programme in improving fitness and psychosocial functioning in a traumatic brain injured population. We aim to carry out a multi-centre, assessor blinded, randomised controlled trial with parallel group design to compare the two interventions. We hypothesize that a supervised fitness-centre based exercise programme, compared to an unsupervised home-based programme will show significant improvements in cardiorespiratory fitness, depression and community integration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35155 0
Address 35155 0
Country 35155 0
Phone 35155 0
Fax 35155 0
Email 35155 0
Contact person for public queries
Name 10045 0
Leanne Hassett
Address 10045 0
Brain Injury Rehabilitation Unit
Liverpool Health Service
Locked Bag 7103
Liverpool BC NSW 1871
Country 10045 0
Australia
Phone 10045 0
+61 2 98285495
Fax 10045 0
+61 2 98285497
Email 10045 0
leanne.hassett@sswahs.nsw.gov.au
Contact person for scientific queries
Name 973 0
Leanne Hassett
Address 973 0
Brain Injury Rehabilitation Unit
Liverpool Health Service
Locked Bag 7103
Liverpool BC NSW 1871
Country 973 0
Australia
Phone 973 0
+61 2 98285495
Fax 973 0
+61 2 9828 5497
Email 973 0
leanne.hassett@sswahs.nsw.gov.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