NCT Number: NCT00251108
Fitness Training After Traumatic Brain Injury
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.
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Notify MeKey information
Conditions
Age range
15 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Brain Injury Rehabilitation Unit, Liverpool Health Service, Sydney, New South Wales, Australia
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
Secondary outcomes
-
Depression Anxiety Stress Scales (DASS)
-
Profile of Moods Scale (POMS)
-
BICRO-39
-
Sydney Psychosocial Reintegration Scale (SPRS)
-
Body Mass Index (BMI)
-
Rate of Perceived Exertion (RPE)
-
Hip to Waist ratio
Sponsors and collaborators
Lead sponsor
Sydney South West Area Health Service
Other Gov
Collaborators
- Motor Accidents Authority of NSW
Registry information
Official study 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
Important dates
- Study start
- 2003
- Study completion
- 2007
- First posted
- Nov 9, 2005
- Registry last updated
- Mar 1, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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