Fitness Training After Traumatic Brain Injury

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Craniocerebral Trauma	Procedure: Cardiorespiratory fitness training	Not Applicable

Detailed Description:

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:

Secondary Outcome Measures :

1. Depression Anxiety Stress Scales (DASS)
2. Profile of Moods Scale (POMS)
3. BICRO-39
4. Sydney Psychosocial Reintegration Scale (SPRS)
5. Body Mass Index (BMI)
6. Rate of Perceived Exertion (RPE)
7. Hip to Waist ratio

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Sydney South West Area Health Service

Motor Accidents Authority of NSW

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00251108 History of Changes
Other Study ID Numbers:	02/052; 02/040
First Posted:	November 9, 2005
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