Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000522415
Ethics application status
Approved
Date submitted
8/10/2007
Date registered
10/10/2007
Date last updated
5/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The intensity of a circuit class for people following severe traumatic brain injury
Scientific title
To compare the percentage of time spent within the training heart rate zone for people following severe traumatic brain injury with and without the use of external feedback
Secondary ID [1] 473 0
2007/090
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury 2432 0
Condition category
Condition code
Injuries and Accidents 2534 2534 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Attendance at standard circuit class run three times per week at the brain injury rehabilitation unit at Liverpool Hospital, with the use of a heart rate monitor and physiotherapist to provide auditory, visual and verbal feedback of exercise intensity with the aim to work within the training heart rate zone (50-70% heart rate reserve). The intervention phase will last for 2 weeks (6 sessions)
Intervention code [1] 2154 0
Rehabilitation
Comparator / control treatment
Attendance at standard circuit class run three times per week at the brain injury rehabilitation unit at Liverpool Hospital, with no specific feedback regarding intensity of exercise. The intervention phase will last for 2 weeks (6 sessions)
Control group
Active

Outcomes
Primary outcome [1] 3435 0
Percentage of time spent at or above the training heart rate (50-70% heart rate reserve)
Timepoint [1] 3435 0
At baseline (3 sessions) before randomisation and immediately after the intervention (3 sessions)
Secondary outcome [1] 5713 0
Descriptions of the exercise (frequency, duration, average heart rate, maximum heart rate and calories burnt)
Timepoint [1] 5713 0
At baseline (3 sessions) before randomisation and immediately after the intervention (3 sessions)

Eligibility
Key inclusion criteria
1)sustained a very severe or extremely severe traumatic brain injury (i.e. post traumatic amnesia period > 1 week); 2) currently attending or eligible to attend the circuit class three times per week and anticipated to attend for at least 4 weeks; 3) medical consent
Minimum age
15 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) still in post traumatic amnesia; 2) have any behaviour problems not suitable for a group environment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will attend the circuit class with heart rate monitor on (auditory feedback turned off) for three sessions. Participants who fail to spend > or = 30 mins above 50% heart rate reserve, they will be randomised using concealed allocation (sequentially numbered opaque sealed envelopes) into either the experimental or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number list. This was generated and the envelopes were prepared by an investigator not involved in participant recruitment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 452 0
1871

Funding & Sponsors
Funding source category [1] 2683 0
Self funded/Unfunded
Name [1] 2683 0
Country [1] 2683 0
Primary sponsor type
Hospital
Name
Brain Injury Rehabilitation Unit, Liverpool Health Service
Address
Elizabeth Street Liverpool, NSW, 2170
Country
Australia
Secondary sponsor category [1] 2427 0
University
Name [1] 2427 0
Faculty of Health Sciences, University of Sydney
Address [1] 2427 0
East Street, Lidcombe, NSW, 1825
Country [1] 2427 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4604 0
Sydney South West Area Health Service (Western zone)
Ethics committee address [1] 4604 0
Ethics committee country [1] 4604 0
Australia
Date submitted for ethics approval [1] 4604 0
Approval date [1] 4604 0
28/08/2007
Ethics approval number [1] 4604 0
2007/090

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28096 0
Address 28096 0
Country 28096 0
Phone 28096 0
Fax 28096 0
Email 28096 0
Contact person for public queries
Name 11253 0
Leanne Hassett
Address 11253 0
Brain Injury Rehabilitation Unit, Liverpool Health Service. Locked Bag 7103 Liverpool BC 1871
Country 11253 0
Australia
Phone 11253 0
+61-2-98285495
Fax 11253 0
+61-2-98285497
Email 11253 0
[email protected]
Contact person for scientific queries
Name 2181 0
Leanne Hassett
Address 2181 0
Brain Injury Rehabilitation Unit, Liverpool Health Service. Locked Bag 7103 Liverpool BC 1871
Country 2181 0
Australia
Phone 2181 0
+61-2-98285495
Fax 2181 0
+61-2-98285497
Email 2181 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.