Fitness Training After Traumatic Brain Injury
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ClinicalTrials.gov Identifier: NCT00251108 |
Recruitment Status
:
Completed
First Posted
: November 9, 2005
Last Update Posted
: March 1, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Craniocerebral Trauma | Procedure: Cardiorespiratory fitness training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | October 2003 |
Study Completion Date : | March 2007 |

- Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
- Depression Anxiety Stress Scales (DASS)
- Profile of Moods Scale (POMS)
- BICRO-39
- Sydney Psychosocial Reintegration Scale (SPRS)
- Body Mass Index (BMI)
- Rate of Perceived Exertion (RPE)
- Hip to Waist ratio

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Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251108
Australia, New South Wales | |
Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney | |
Sydney, New South Wales, Australia, 1680 | |
Brain Injury Rehabilitation Unit, Liverpool Health Service | |
Sydney, New South Wales, Australia, 2117 | |
Brain Injury Rehabilitation Unit, Westmead Hospital | |
Sydney, New South Wales, Australia, 2145 |
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 |
ClinicalTrials.gov Identifier: | NCT00251108 History of Changes |
Other Study ID Numbers: |
02/052 02/040 |
First Posted: | November 9, 2005 Key Record Dates |
Last Update Posted: | March 1, 2007 |
Last Verified: | February 2007 |
Keywords provided by Sydney South West Area Health Service:
'traumatic brain injury' 'head injury' 'brain injuries' 'exercise therapy' 'physical fitness' |
Additional relevant MeSH terms:
Brain Injuries Brain Injuries, Traumatic Craniocerebral Trauma Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries |