Fitness Training After Traumatic Brain Injury

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Cardiorespiratory fitness training

About this trial

This is an interventional treatment trial for Craniocerebral Trauma focused on measuring 'traumatic brain injury', 'head injury', 'brain injuries', 'exercise therapy', 'physical fitness'

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney
Brain Injury Rehabilitation Unit, Liverpool Health Service
Brain Injury Rehabilitation Unit, Westmead Hospital

Outcomes

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

Full Information

NCT ID

NCT00251108

First Posted

November 8, 2005

Last Updated

February 28, 2007

Sponsor

Sydney South West Area Health Service

Collaborators

Motor Accidents Authority of NSW

1. Study Identification

Unique Protocol Identification Number

NCT00251108

Brief Title

Fitness Training After Traumatic Brain Injury

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sydney South West Area Health Service

Collaborators

Motor Accidents Authority of NSW

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Craniocerebral Trauma

Keywords

'traumatic brain injury', 'head injury', 'brain injuries', 'exercise therapy', 'physical fitness'

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Cardiorespiratory fitness training

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Depression Anxiety Stress Scales (DASS)

Title

Profile of Moods Scale (POMS)

Title

BICRO-39

Title

Sydney Psychosocial Reintegration Scale (SPRS)

Title

Body Mass Index (BMI)

Title

Rate of Perceived Exertion (RPE)

Title

Hip to Waist ratio

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leanne M Hassett, MHSc

Organizational Affiliation

Brain Injury Rehabilitation Unit, Liverpool Health Service, SSWAHS

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robyn Tate, PhD

Organizational Affiliation

Rehabilitation Studies Unit, Royal Rehabilitation Centre Sydney

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anne M Moseley, PhD

Organizational Affiliation

University of Sydney

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alison R Harmer, PhD

Organizational Affiliation

University of Sydney

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brain Injury Rehabilitation Unit, Royal Rehabilitation Centre Sydney

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

1680

Country

Australia

Facility Name

Brain Injury Rehabilitation Unit, Liverpool Health Service

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2117

Country

Australia

Facility Name

Brain Injury Rehabilitation Unit, Westmead Hospital

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Craniocerebral Trauma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial