Fitness Training After Traumatic Brain Injury

Craniocerebral Trauma Clinical Trial

Official 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

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
• 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

• Craniocerebral Trauma

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