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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
Information provided by:

Study Description
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
Craniocerebral Trauma Procedure: Cardiorespiratory fitness training

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

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries
U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Information from the National Library of Medicine

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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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Sydney South West Area Health Service
Motor Accidents Authority of NSW
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

ClinicalTrials.gov Identifier: NCT00251108     History of Changes
Other Study ID Numbers: 02/052
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