Fitness Training After Traumatic Brain Injury
This study has been completed.
Sponsor:
Sydney South West Area Health Service
Collaborator:
Motor Accidents Authority of NSW
Information provided by:
Sydney South West Area Health Service
ClinicalTrials.gov Identifier:
NCT00251108
First received: November 8, 2005
Last updated: February 28, 2007
Last verified: February 2007
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Craniocerebral Trauma |
Procedure: Cardiorespiratory fitness training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sydney South West Area Health Service:
Primary Outcome Measures:
- Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | March 2007 |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251108
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251108
Locations
| Australia, New South Wales | |
| Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney | |
| Sydney, New South Wales, Australia, 1680 | |
| Brain Injury Rehabilitation Unit, Liverpool Health Service | |
| Sydney, New South Wales, Australia, 2117 | |
| Brain Injury Rehabilitation Unit, Westmead Hospital | |
| Sydney, New South Wales, Australia, 2145 | |
Sponsors and Collaborators
Sydney South West Area Health Service
Motor Accidents Authority of NSW
Investigators
| Principal Investigator: | Leanne M Hassett, MHSc | Brain Injury Rehabilitation Unit, Liverpool Health Service, SSWAHS |
| Principal Investigator: | Robyn Tate, PhD | Rehabilitation Studies Unit, Royal Rehabilitation Centre Sydney |
| Principal Investigator: | Anne M Moseley, PhD | University of Sydney |
| Principal Investigator: | Alison R Harmer, PhD | University of Sydney |
More Information
| ClinicalTrials.gov Identifier: | NCT00251108 History of Changes |
| Other Study ID Numbers: | 02/052 02/040 |
| Study First Received: | November 8, 2005 |
| Last Updated: | February 28, 2007 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Sydney South West Area Health Service:
|
'traumatic brain injury' 'head injury' 'brain injuries' 'exercise therapy' 'physical fitness' |
Additional relevant MeSH terms:
|
Brain Injuries Craniocerebral Trauma Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on September 30, 2016