Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000525482
Ethics application status
Approved
Date submitted
8/10/2007
Date registered
11/10/2007
Date last updated
11/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a screening program for early balance problems and a targeted exercise intervention in older people
Scientific title
In older people with early balance problems, is a home-based targeted exercise intervention effective in improving balance performance?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance dysfunction in older people 2433 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2535 2535 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A home-based targeted exercise program prescribed by a physiotherapist. This is a balance and strength training program, 5 times a week for 6 months based on the Otago Exercise Program.
Intervention code [1] 2155 0
Other interventions
Comparator / control treatment
Participants in the control group will receive usual care---receive a brochure outlining falls risk factors and falls prevention strategies.
Control group
Active

Outcomes
Primary outcome [1] 3436 0
laboratory meausres of balance performance, measured by the NeuroCom Balance Master (Long plate). e.g. Modifided Clinical Test of Sensory Interaction Stability (CTSIB), composite score.
Timepoint [1] 3436 0
at six months after randomisation
Primary outcome [2] 3437 0
Clinical measures of balance, mobility and muscle strength. e.g. Step Test (ST); walking velocity; abductor muscle strength meausred by hand-held dynamometer.
Timepoint [2] 3437 0
at six month after randomisation
Secondary outcome [1] 5714 0
Activity level measured by the Human Activity Profile (HAP)
Timepoint [1] 5714 0
at six months after randomisation
Secondary outcome [2] 5715 0
Quality of Life measured by the Assessment of Quality of Life (AQoL)
Timepoint [2] 5715 0
at six months after randomisation
Secondary outcome [3] 5716 0
Fear of falling meausred by the Modified Falls Efficacy Scale (MFES)
Timepoint [3] 5716 0
at six months after randomisation
Secondary outcome [4] 5717 0
Falls incidence during the follow-up period, recorded by Falls History
Timepoint [4] 5717 0
at six months after randomisation

Eligibility
Key inclusion criteria
being aged 65 years; living in the community (at home or in a retirement village); being community ambulant; uses no walking aid or only a single point stick; has had no more than one fall in the past 12 months; has concerns about balance, confidence or near falls.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
people younger than 65 years; people live in a residential care facility; people who walk away from home less than three times weekly; people who use a walking frame; people who have had more than one fall in the past year; people who have no concern about balance, confidence or near falls.

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site"---a researcher who is not involved in recruiting or assessing participant does the allocation. She is contacted to give the group allocation after a participant is considered eligiable and undergo the baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (SPSS11.0)
Masking / blinding
Blinded (masking 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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
205
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 453 0
3001

Funding & Sponsors
Funding source category [1] 2684 0
Government body
Name [1] 2684 0
The Department of Veterans' Affairs
Country [1] 2684 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
National Ageing Research Institute (NARI)
Address
34-54 Poplar Road, Parkville
PO Box 31 Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 2428 0
University
Name [1] 2428 0
The University of Melbourne
Address [1] 2428 0
Level 2, 723 Swonston Street
Calton VIC 3053
Country [1] 2428 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4606 0
DVA Human Research Ethics Committee (DVA HREC)
Ethics committee address [1] 4606 0
HREC, Department of Veterans' Affairs
PO Box 21 Woden ACT 2606
Ethics committee country [1] 4606 0
Australia
Date submitted for ethics approval [1] 4606 0
Approval date [1] 4606 0
11/11/2005
Ethics approval number [1] 4606 0

Summary
Brief summary
This randomised controlled trial is using the Neurocom Balance Master force platform for early detection of balance problems amongst older community ambulant Veterans. For Veterans who are assessed as having balance outside of normal limits for their age, they will be randomised to either receive usual care or an exercise program. The exercise program will be a targeted balance and strength training program developed by a physiotherapist (based on the Otago exercise program that has been shown to reduce falls). After six months a follow-up balance assessment will be undertaken to determine whether the exercise program has brought balance back to within normal limits. This study will provide a better understanding of the types of early balance problems that occur, the frequency of undetected balance problems in a reasonably well sample, and the response of a targeted exercise program in addressing the early presence of balance problems in community ambulant Veterans. The study is due to be completed in the later half of 2008.
Trial website
http://www.nari.unimelb.edu.au/research/research_falls_clinical.htm
Trial related presentations / publications
Nov. 2006, Brisbane, at the 2nd Australian Falls Prevention Conference:
Yang X, Hill K, Dharmage S, Black K, Williams S, Tarquinio S. Early screening of balance problems in older community ambulant Veterans

Oct. 2007, Beijing (abstract accepted), at the 8th Asia/Oceania Regional Congress of Gerontology and Geriatrics:
Yang X, Hill K, Moore K, Williams S, Dowson L, Dharmage S. Early screening for balance problems and targeted exercise interventions among older people
Public notes

Contacts
Principal investigator
Name 28097 0
Address 28097 0
Country 28097 0
Phone 28097 0
Fax 28097 0
Email 28097 0
Contact person for public queries
Name 11254 0
Xiao Jing Yang
Address 11254 0
Preventive medicine and public health division, PO Box 31 Parkville VIC 3052
Country 11254 0
Australia
Phone 11254 0
03-8387 2383
Fax 11254 0
03-8387 2153
Email 11254 0
[email protected]
Contact person for scientific queries
Name 2182 0
Keith Hill
Address 2182 0
Preventive medicine and public health division, PO Box 31 Parkville VIC 3052
Country 2182 0
Australia
Phone 2182 0
03-8387 2626
Fax 2182 0
03-8387 2153
Email 2182 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
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