Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000071527
Ethics application status
Approved
Date submitted
15/02/2006
Date registered
21/02/2006
Date last updated
18/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Central Sydney Tai Chi trial
Scientific title
The Central Sydney Tai Chi trial: A randomised controlled trial investigating the effectiveness of Tai Chi in reducing the risk of falling in older people
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in older people 1035 0
Condition category
Condition code
Public Health 1111 1111 0 0
Health promotion/education
Injuries and Accidents 1112 1112 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 16-week introductory, community-based Tai Chi programme for older people consisting of 1-hour classes held weekly
Intervention code [1] 897 0
Prevention
Comparator / control treatment
Control group participants were placed on a waiting list to do tai chi after the intervention classes had finished. Control group participants were requested to not do any other tai chi during the study period
Control group
Active

Outcomes
Primary outcome [1] 1482 0
Number of fallers
Timepoint [1] 1482 0
At the end of the study period at 6-months.
Secondary outcome [1] 2663 0
Number of falls; time to fall
Timepoint [1] 2663 0
At the end of the study period at 6-months.
Secondary outcome [2] 2664 0
Balance while standing, leaning and stepping
Timepoint [2] 2664 0
At the end of the intervention at 4-months.

Eligibility
Key inclusion criteria
Living in the community; no experience with Tai Chi for at least the previous 12 months.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Degenerative neurological condition( such as Parkinson’s or Alzheimer’s disease); a severely debilitating stroke; dementia; severe arthritis; marked vision impairment; or if unable to walk across a room unaided.

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)
Concealed randomised sequence held by chief investigator with allocation only after completion of baseline measures
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table was used to generate the sequence using random permuted blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Waiting-list controlled group was offered the Tai Chi programme at the end of the study period
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/04/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
758
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1216 0
Government body
Name [1] 1216 0
NSW Health, Centre for Chronic Disease Prevention and Health Enhancement
Country [1] 1216 0
Australia
Primary sponsor type
Government body
Name
Health Promotion Service, Sydney South West Area Health Service
Address
Level 9 (North), King George V building, Missenden Road, Camperdown, NSW. 2050
Country
Australia
Secondary sponsor category [1] 1074 0
None
Name [1] 1074 0
N/A
Address [1] 1074 0
Country [1] 1074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2550 0
Central Sydney Area Health Service Ethics Review Committee (Royal Prince Alfred Hospital zone)
Ethics committee address [1] 2550 0
Ethics committee country [1] 2550 0
Australia
Date submitted for ethics approval [1] 2550 0
Approval date [1] 2550 0
28/06/2001
Ethics approval number [1] 2550 0
X00-0254

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

Contacts
Principal investigator
Name 35666 0
Address 35666 0
Country 35666 0
Phone 35666 0
Fax 35666 0
Email 35666 0
Contact person for public queries
Name 10086 0
Alexander Voukelatos
Address 10086 0
Health Promotion
Level 9 (North)
King George V (KGV) Building
Missenden Rd
Camperdown 2050 NSW
Country 10086 0
Australia
Phone 10086 0
+61 2 95159079
Fax 10086 0
+61 2 95159056
Email 10086 0
[email protected]
Contact person for scientific queries
Name 1014 0
Alexander Voukelatos
Address 1014 0
Health Promotion
Level 9 (North)
King George V (KGV) Building
Missenden Rd
Camperdown 2050 NSW
Country 1014 0
Australia
Phone 1014 0
+61 2 95159079
Fax 1014 0
+61 2 95159056
Email 1014 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.