Fitness Training After Traumatic Brain Injury
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
2 other identifiers
interventional
60
1 country
3
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2003
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 8, 2005
CompletedFirst Posted
Study publicly available on registry
November 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMarch 1, 2007
February 1, 2007
November 8, 2005
February 28, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
Secondary Outcomes (7)
Depression Anxiety Stress Scales (DASS)
Profile of Moods Scale (POMS)
BICRO-39
Sydney Psychosocial Reintegration Scale (SPRS)
Body Mass Index (BMI)
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney
Sydney, New South Wales, 1680, Australia
Brain Injury Rehabilitation Unit, Liverpool Health Service
Sydney, New South Wales, 2117, Australia
Brain Injury Rehabilitation Unit, Westmead Hospital
Sydney, New South Wales, 2145, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leanne M Hassett, MHSc
Brain Injury Rehabilitation Unit, Liverpool Health Service, SSWAHS
- PRINCIPAL INVESTIGATOR
Robyn Tate, PhD
Rehabilitation Studies Unit, Royal Rehabilitation Centre Sydney
- PRINCIPAL INVESTIGATOR
Anne M Moseley, PhD
University of Sydney
- PRINCIPAL INVESTIGATOR
Alison R Harmer, PhD
University of Sydney
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
November 8, 2005
First Posted
November 9, 2005
Study Start
October 1, 2003
Study Completion
March 1, 2007
Last Updated
March 1, 2007
Record last verified: 2007-02