Fitness Training After Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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The objective of this project is to compare a three-month supervised fitness centre-based exercise programme to a 3-month unsupervised home-based exercise programme on discharge from inpatient rehabilitation on improving cardiorespiratory fitness and psychosocial functioning in a traumatic brain injured population. We plan to carry out a multi-centre, assessor blinded, randomised controlled trial with a parallel group design to compare the two interventions. We hypothesise that the supervised fitness-centre based programme will provide significantly better outcomes, and that these gains will not only be evident on completion of the programme, but will be maintained on follow-up, thereby demonstrating that investment in a supervised exercise programme can provide beneficial long-term effects.

Official Title
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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

Conditions
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Craniocerebral Trauma

Intervention / Treatment
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* Procedure: Cardiorespiratory fitness training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cardiorespiratory fitness training|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test: |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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'traumatic brain injury', 'head injury', 'brain injuries', 'exercise therapy', 'physical fitness'