Fitness Training After Traumatic Brain Injury | NCT00251108

Studies
Fitness Training After Traumatic Brain Injury

NCT00251108

Sponsor

Sydney South West Area Health Service

Status

Completed

Last Update Posted

Mar 1, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Craniocerebral Trauma

Interventions

Cardiorespiratory fitness training

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
02/040

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Not provided

Completion Date

Mar 2007

First Submitted Date

Nov 8, 2005

First Submission Date that Met QC Criteria

Nov 8, 2005

First Posted Date

Nov 9, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2007

Last Update Posted Date

Mar 1, 2007Estimated

Name	Class
Motor Accidents Authority of NSW	UNKNOWN

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Cardiorespiratory fitness training	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of Cardiorespiratory fitness:Modified 20 metre Walk/Run Shuttle Test:

Secondary Outcomes

Measure	Description	Time Frame
Depression Anxiety Stress Scales (DASS)
Profile of Moods Scale (POMS)
BICRO-39

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney		Sydney	New South Wales	1680	Australia

Condition Browse Module

MeSH Terms

ID	Term
D006259	Craniocerebral Trauma
D000070642	Brain Injuries, Traumatic
D001930	Brain Injuries

Ancestor Terms

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

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