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OpenTrials
Completed

NCT Number: NCT00251108

Fitness Training After Traumatic Brain Injury

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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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Injury Rehabilitation Unit, Liverpool Health Service, Sydney, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiorespiratory fitness training

Procedure

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sydney South West Area Health Service

Other Gov

Collaborators

  • Motor Accidents Authority of NSW

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2007
First posted
Nov 9, 2005
Registry last updated
Mar 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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