Fitness Training After Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Craniocerebral Trauma

• Registration Number: NCT00251108
• Lead Sponsor: Sydney South West Area Health Service

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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-11-08
• Study First Submitted QC: 2005-11-08
• Study First Posted: 2005-11-09
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-28
• Study Completion: 2007-03
• Last Update Posted: 2007-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney; 🇦🇺 Sydney, New South Wales, Australia

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

Brain Injury Rehabilitation Unit, Westmead Hospital; 🇦🇺 Sydney, New South Wales, Australia