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Clinical Trials/NCT00251108
NCT00251108
Completed
Not Applicable

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

Sydney South West Area Health Service3 sites in 1 country60 target enrollmentOctober 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Craniocerebral Trauma
Sponsor
Sydney South West Area Health Service
Enrollment
60
Locations
3
Primary Endpoint
Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
Status
Completed
Last Updated
19 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2003
End Date
March 2007
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Rate of Perceived Exertion (RPE)
  • Hip to Waist ratio
  • BICRO-39
  • Body Mass Index (BMI)
  • Sydney Psychosocial Reintegration Scale (SPRS)
  • Depression Anxiety Stress Scales (DASS)
  • Profile of Moods Scale (POMS)

Study Sites (3)

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