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Fitness Training After Traumatic Brain Injury

S

Sydney South West Area Health Service

Status

Completed

Conditions

Craniocerebral Trauma

Treatments

Procedure: Cardiorespiratory fitness training

Study type

Interventional

Funder types

Other

Identifiers

NCT00251108
02/040
02/052

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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