Craniocerebral TraumaNCT00251108
Fitness Training After Traumatic Brain Injury
A study testing Cardiorespiratory fitness training in people with Craniocerebral Trauma, run by Sydney South West Area Health Service at 3 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Craniocerebral Trauma
- What is being tested?
- Cardiorespiratory fitness training
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 3 sitesAustralia
- Study dates
- Oct 2003to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney
Sydney, New South Wales, 1680
Brain Injury Rehabilitation Unit, Liverpool Health Service
Sydney, New South Wales, 2117
Brain Injury Rehabilitation Unit, Westmead Hospital
Sydney, New South Wales, 2145
About this study
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
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.
Read the 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.
- Conditions
- Craniocerebral Trauma
- Being tested
- Cardiorespiratory fitness training
- Keywords
- 'traumatic brain injury', 'head injury', 'brain injuries', 'exercise therapy', 'physical fitness'
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory fitness trainingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
Secondary outcomes (7)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startOct 2003
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniocerebral TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Sydney South West Area Health Service
- Sponsor type
- Other government
- Collaborators
- Motor Accidents Authority of NSW
- Investigators
- Leanne M Hassett, MHSc, Principal investigator, Brain Injury Rehabilitation Unit, Liverpool Health Service, SSWAHSRobyn Tate, PhD, Principal investigator, Rehabilitation Studies Unit, Royal Rehabilitation Centre SydneyAnne M Moseley, PhD, Principal investigator, University of SydneyAlison R Harmer, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251108
- Sponsor's protocol ID
- 02/052
- Other IDs
- 02/040
- Status last verified
- Feb 2007
- First submitted
- 8 Nov 2005
- Last updated
- 1 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00251108
- Acronym / sponsor ID
- 02/052
- Conditions
- Craniocerebral Trauma
- Keywords
- 'traumatic brain injury', 'head injury', 'brain injuries', 'exercise therapy', 'physical fitness'
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Sydney South West Area Health ServiceOther government
- Collaborators
- Motor Accidents Authority of NSW
- Study start
- Oct 2003
- Study completion
- Mar 2007
- First posted
- 9 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiorespiratory fitness training | Procedure or surgery | – |
Primary outcome
Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:
7 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
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Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanne M Hassett, MHSc principal investigator
Brain Injury Rehabilitation Unit, Liverpool Health Service, SSWAHS
Robyn Tate, PhD principal investigator
Rehabilitation Studies Unit, Royal Rehabilitation Centre Sydney
Anne M Moseley, PhD principal investigator
University of Sydney
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiorespiratory fitness training in people with Craniocerebral Trauma, run by Sydney South West Area Health Service at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2007.