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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00251108
Other study ID # 02/052
Secondary ID 02/040
Status Completed
Phase N/A
First received November 8, 2005
Last updated February 28, 2007
Start date October 2003
Est. completion date March 2007

Study information

Verified date February 2007
Source Sydney South West Area Health Service
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Cardiorespiratory fitness training


Locations

Country Name City State
Australia Brain Injury Rehabilitation Unit, Liverpool Health Service Sydney New South Wales
Australia Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney Sydney New South Wales
Australia Brain Injury Rehabilitation Unit, Westmead Hospital Sydney New South Wales

Sponsors (2)

Lead Sponsor Collaborator
Sydney South West Area Health Service Motor Accidents Authority of NSW

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
Secondary Depression Anxiety Stress Scales (DASS)
Secondary Profile of Moods Scale (POMS)
Secondary BICRO-39
Secondary Sydney Psychosocial Reintegration Scale (SPRS)
Secondary Body Mass Index (BMI)
Secondary Rate of Perceived Exertion (RPE)
Secondary Hip to Waist ratio
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