Fitness Training After Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-03-31

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.

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Critical Illness

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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.

Conditions

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Craniocerebral Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Cardiorespiratory fitness training

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No