Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000018415
Ethics application status
Approved
Date submitted
19/07/2006
Date registered
10/01/2007
Date last updated
21/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of the ACC Tai Chi programme
Scientific title
An evaluation of the Accident Compensation Corporation (ACC) Tai Chi programme in older adults: does it reduce falls
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in older adults
Balance 1519 0
Condition category
Condition code
Injuries and Accidents 1617 1617 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All training sessions are of 1 hour duration for a 20 week period.
Tai Chi training 1x week (intervention group)
Tai Chi training 2X week (intervention group)
Intervention code [1] 1215 0
Prevention
Comparator / control treatment
Flexibility training 1x week (control group)
Control group
Active

Outcomes
Primary outcome [1] 2230 0
Falls
Timepoint [1] 2230 0
At 20 weeks, 6 months and 12 months
Secondary outcome [1] 3888 0
Balance confidence (ABC scale)
Timepoint [1] 3888 0
Measured at baseline, then at 20 weeks, 6 months and 12 months
Secondary outcome [2] 3889 0
Balance (step test, single leg stance)
Timepoint [2] 3889 0
Measured at baseline, then at 20 weeks, 6 months and 12 months
Secondary outcome [3] 3890 0
Functional mobility (timed up and go)
Timepoint [3] 3890 0
Measured at baseline, then at 20 weeks, 6 months and 12 months
Secondary outcome [4] 3891 0
Lower limb strength (30s chair stand test)
Timepoint [4] 3891 0
Measured at baseline, then at 20 weeks, 6 months and 12 months
Secondary outcome [5] 3892 0
Health related quality of life (SF36 v2)
Timepoint [5] 3892 0
Measured at baseline, then at 20 weeks, 6 months and 12 months

Eligibility
Key inclusion criteria
Participants will be included if they are over the age of 65 years (55 years if Maori or Pacific Islander) have experienced at least one fall in the previous 12 months or have a falls risk factor according to the Falls Risk Assessment Tool (FRAT).
Minimum age
55 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to walk independently (with or without walking aid), chronic medical condition that would limit participation in low-moderate exercise, severe cognitive limitations (telephone Mini mental state examination score <20), currently participating in an organised exercise programme of equivalent intensity as the study intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be made on eligible individuals stratified by site and blocked to ensure balanced numbers over the three interventions. This will be done using a specialist computer program (see: http://www.randomization.com/).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Independent assessors will be blinded.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
684
Accrual to date
Final
Recruitment outside Australia
Country [1] 381 0
New Zealand
State/province [1] 381 0

Funding & Sponsors
Funding source category [1] 1764 0
Government body
Name [1] 1764 0
Accident Compensation Corporation (New Zealand)
Country [1] 1764 0
New Zealand
Primary sponsor type
Individual
Name
Dr Denise Taylor (Auckland University of Technology)
Address
Health & Rehabilitation Research Centre, AUT, Auckland, NZ
Country
New Zealand
Secondary sponsor category [1] 1563 0
Individual
Name [1] 1563 0
Dr Leigh Hale
Address [1] 1563 0
University of Otago
Country [1] 1563 0
New Zealand
Secondary sponsor category [2] 1564 0
Individual
Name [2] 1564 0
Professor Kathryn McPherson
Address [2] 1564 0
AUT
Country [2] 1564 0
New Zealand
Secondary sponsor category [3] 1565 0
Individual
Name [3] 1565 0
Dr Noela Wilson
Address [3] 1565 0
University of Otago
Country [3] 1565 0
New Zealand
Secondary sponsor category [4] 1566 0
Individual
Name [4] 1566 0
Dr Debra Waters
Address [4] 1566 0
University of Otago
Country [4] 1566 0
New Zealand
Secondary sponsor category [5] 1567 0
Individual
Name [5] 1567 0
Professor Philip Schluter
Address [5] 1567 0
AUT
Country [5] 1567 0
New Zealand
Secondary sponsor category [6] 1568 0
Individual
Name [6] 1568 0
Mr Hamish McCracken
Address [6] 1568 0
University of Auckland
Country [6] 1568 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3292 0
Auckland
Ethics committee address [1] 3292 0
Ethics committee country [1] 3292 0
New Zealand
Date submitted for ethics approval [1] 3292 0
Approval date [1] 3292 0
08/05/2006
Ethics approval number [1] 3292 0
06/67
Ethics committee name [2] 3293 0
Dunedin
Ethics committee address [2] 3293 0
Ethics committee country [2] 3293 0
New Zealand
Date submitted for ethics approval [2] 3293 0
Approval date [2] 3293 0
18/05/2006
Ethics approval number [2] 3293 0
06/045
Ethics committee name [3] 3294 0
Christchurch
Ethics committee address [3] 3294 0
Ethics committee country [3] 3294 0
New Zealand
Date submitted for ethics approval [3] 3294 0
Approval date [3] 3294 0
18/05/2006
Ethics approval number [3] 3294 0
06/045
Ethics committee name [4] 3295 0
Whangarei
Ethics committee address [4] 3295 0
Ethics committee country [4] 3295 0
New Zealand
Date submitted for ethics approval [4] 3295 0
Approval date [4] 3295 0
04/12/2006
Ethics approval number [4] 3295 0
06/67

Summary
Brief summary
Falls and injuries resulting from falls are a major concern to New Zealand Health providers and the population in general. The consequences of falling in older age can be devastating to the individual and costly to health providers, such as ACC. We already know that interventions aimed at reducing risk factors for falls in frailer older adults can be effective, and the results of the Otago Exercise Programme support this. However, we don’t know how effective ACC funded Tai Chi programmes are in reducing falls. This proposal seeks to clarify the effectiveness of ACC funded Tai Chi programmes as a means of reducing the incidence of falls in older adults. It will also aim to determine if the frequency of practice of Tai Chi is an important determinant of effectiveness. Clarifying if Tai Chi programmes, as delivered in New Zealand, reduce falls and fall related injuries, and clarifying the frequency of delivery and the longer term effects of the programmes would be of significant benefit to older individuals who are at risk of falling, to ACC as a major funder of falls prevention programmes, and to the health industry in general. An economic evaluation of the Tai Chi programmes would be of benefit in enabling ACC to plan and implement future cost effective programmes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36384 0
Address 36384 0
Country 36384 0
Phone 36384 0
Fax 36384 0
Email 36384 0
Contact person for public queries
Name 10404 0
Dr Denise Taylor
Address 10404 0
Physical Rehabilitation Research Centre
School of Physiotherapy
Auckland University of Technology (AUT)
Akoranga Campus
Northcote
Auckland
Country 10404 0
New Zealand
Phone 10404 0
+64 9 9219680
Fax 10404 0
Email 10404 0
[email protected]
Contact person for scientific queries
Name 1332 0
Dr Denise Taylor
Address 1332 0
Physical Rehabilitation Research Centre
School of Physiotherapy
Auckland University of Technology (AUT)
Akoranga Campus
Northcote
Auckland
Country 1332 0
New Zealand
Phone 1332 0
+64 9 9219680
Fax 1332 0
Email 1332 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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