Craniocerebral Trauma Clinical Trial
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
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Brain Injury Rehabilitation Unit, Liverpool Health Service | Sydney | New South Wales |
Australia | Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney | Sydney | New South Wales |
Australia | Brain Injury Rehabilitation Unit, Westmead Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Sydney South West Area Health Service | Motor Accidents Authority of NSW |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test: | |||
Secondary | Depression Anxiety Stress Scales (DASS) | |||
Secondary | Profile of Moods Scale (POMS) | |||
Secondary | BICRO-39 | |||
Secondary | Sydney Psychosocial Reintegration Scale (SPRS) | |||
Secondary | Body Mass Index (BMI) | |||
Secondary | Rate of Perceived Exertion (RPE) | |||
Secondary | Hip to Waist ratio |
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