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Fitness Training After Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborator:
Motor Accidents Authority of NSW
Information provided by:
Sydney South West Area Health Service
ClinicalTrials.gov Identifier:
NCT00251108
First received: November 8, 2005
Last updated: February 28, 2007
Last verified: February 2007
History of Changes
  Purpose

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 Intervention
Craniocerebral Trauma
 Procedure: Cardiorespiratory fitness training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sydney South West Area Health Service:

Primary Outcome Measures:
  • Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:

Secondary Outcome Measures:
  • 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
Estimated Enrollment: 60
Study Start Date: October 2003
Estimated Study Completion Date: March 2007
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.

  Eligibility
Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251108

Locations
Australia, New South Wales
Brain Injury Rehabilitation Unit, Liverpool Health Service
Sydney, New South Wales, Australia, 2117
Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney
Sydney, New South Wales, Australia, 1680
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

No publications provided

ClinicalTrials.gov Identifier: NCT00251108     History of Changes
Other Study ID Numbers: 02/052, 02/040
Study First Received: November 8, 2005
Last Updated: February 28, 2007
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Sydney South West Area Health Service:
'traumatic brain injury'
'head injury'
'brain injuries'
'exercise therapy'
'physical fitness'

Additional relevant MeSH terms:
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on March 02, 2015