Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00251108




Registration number
NCT00251108
Ethics application status
Date submitted
8/11/2005
Date registered
9/11/2005
Date last updated
1/03/2007

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
Secondary ID [1] 0 0
02/040
Secondary ID [2] 0 0
02/052
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Craniocerebral Trauma 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Depression Anxiety Stress Scales (DASS)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Profile of Moods Scale (POMS)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
BICRO-39
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Sydney Psychosocial Reintegration Scale (SPRS)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Body Mass Index (BMI)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Rate of Perceived Exertion (RPE)
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Hip to Waist ratio
Timepoint [7] 0 0

Eligibility
Key inclusion criteria
Patients who have sustained a traumatic brain injury who have completed their inpatient rehabilitation at either of the three Sydney Metropolitan Brain Injury Units (Liverpool, Ryde or Westmead) will be included in this study if they:

* have sustained a very severe or extremely severe traumatic brain injury
* have had a hospital admission of > 1 month
* are able to walk independently at > 1 m/s on discharge
* are able to commit 3 hours per week to a fitness programme
* live within the area serviced by the 3 units
Minimum age
15 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* have a concurrent medical condition for which moderate to high intensity exercise is contraindicated
* are still in Posttraumatic Amnesia (PTA)
* have cognitive or language problems that affect their ability to understand verbal instructions
* have behaviour problems not suitable 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2003
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
Recruitment hospital [1] 0 0
Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney - Sydney
Recruitment hospital [2] 0 0
Brain Injury Rehabilitation Unit, Liverpool Health Service - Sydney
Recruitment hospital [3] 0 0
Brain Injury Rehabilitation Unit, Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
1680 - Sydney
Recruitment postcode(s) [2] 0 0
2117 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Government body
Name
Sydney South West Area Health Service
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Motor Accidents Authority of NSW
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this project is to compare the efficacy of two different fitness exercise programmes on improving fitness and psychosocial functioning in a traumatic brain injured population. We hypothesize that a supervised fitness-centre based exercise programme, compared to an unsupervised home-based exercise programme will show significant improvements in cardiorespiratory fitness, depression and community integration.
Trial website
https://clinicaltrials.gov/study/NCT00251108
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leanne M Hassett, MHSc
Address 0 0
Brain Injury Rehabilitation Unit, Liverpool Health Service, SSWAHS
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00251108