Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000431527
Ethics application status
Approved
Date submitted
15/09/2006
Date registered
5/10/2006
Date last updated
5/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise for independent living
Scientific title
Tai Chi for independent living: RCT of efficacy of Tai Chi in delaying disability among older people
Universal Trial Number (UTN)
Trial acronym
ExIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-clinical disability 1403 0
Condition category
Condition code
Public Health 1498 1498 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study intervention: Focus and Flow Exercise Program (Tai Chi for Arthritis Part I-12 basic moves and Part II-reverse of the 12 basic moves plus additional 9 advanced moves)

Both exercise programs are delivered in group settings, 1 hour sessions twice weekly, for 48 weeks, by trained instructors
Intervention code [1] 1323 0
Lifestyle
Comparator / control treatment
Control intervention: Flex and Bend Exercise Program (stretching and relaxation exercises)
Control group
Active

Outcomes
Primary outcome [1] 2069 0
Physical functioning and disability measured with the Late Life Function and Disability Instrument
Timepoint [1] 2069 0
Measured at baseline and at 48 weeks
Secondary outcome [1] 3559 0
Joint pain, stiffness and function measured with the WOMAC Osteoarthritis Index
Timepoint [1] 3559 0
At baseline, 24 and 48 weeks.
Secondary outcome [2] 3560 0
Cardiac function measured by heart rate and blood pressure
Timepoint [2] 3560 0
At baseline, 24 and 48 weeks.
Secondary outcome [3] 3561 0
Static balance measured by postural sway and single leg stance
Timepoint [3] 3561 0
At baseline, 24 and 48 weeks.
Secondary outcome [4] 3562 0
Dynamic balance measured by the Step Test, Timed up and Go test, and two elements from Berg Balance Scale
Timepoint [4] 3562 0
At baseline, 24 and 48 weeks.
Secondary outcome [5] 3563 0
Falls
Timepoint [5] 3563 0
Measured prospectively for 48 weeks using a falls calendar.
Secondary outcome [6] 3564 0
Fear of falling measured using the modified Tinetti falls efficacy scale
Timepoint [6] 3564 0
At baseline and 48 weeks.
Secondary outcome [7] 3565 0
Concentration and memory measured with the Digit Cancellation and California Verbal Learning Tests
Timepoint [7] 3565 0
At baseline and 48 weeks.
Secondary outcome [8] 3566 0
BMI
Timepoint [8] 3566 0
At baseline and 48 weeks.
Secondary outcome [9] 3567 0
Life satisfaction using the Life Satisfaction Index
Timepoint [9] 3567 0
At baseline and 48 weeks.
Secondary outcome [10] 3568 0
Depression using he Beck Depression Inventory
Timepoint [10] 3568 0
At baseline and 48 weeks.
Secondary outcome [11] 3569 0
Quality of life using the Assessment of Quality of Life instruement
Timepoint [11] 3569 0
At baseline and 48 weeks
Secondary outcome [12] 3570 0
Health services use using data from the Health Insurance Commission, Pharmaceutical Benefits Scheme, and Department of Veteran Affairs
Timepoint [12] 3570 0
For the period from 12 months prior to the intevention through to 12 months after the intervention

Eligibility
Key inclusion criteria
Living in community (including retirement villages)preclinical stage of disability based on measure developed by Fried (J Clin Epi, 2001; 54:889-901
Minimum age
70 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Already participating in Tai Chimoderate cognitive impairmentmajor unstable cariod-pulmonary diseaseterminal cancer or other life threatening illnessmajor psychiatric illnessdo not have approval from general practitioner.

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 phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation stratified by retirement village at which classes held, and by type of residence (retirement village or own home)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors will be blinded to group allocation. Subjects and exercise program leaders will be blinded to true hypothesis as they will be told the aim of the trial is to compare two different exercise programs
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1633 0
Government body
Name [1] 1633 0
National Health and Medical Research Council
Country [1] 1633 0
Australia
Primary sponsor type
Individual
Name
Dr Lesley Day
Address
Country
Secondary sponsor category [1] 1437 0
Individual
Name [1] 1437 0
A/Prof K. Hill
Address [1] 1437 0
Country [1] 1437 0
Secondary sponsor category [2] 1438 0
Individual
Name [2] 1438 0
Prof L. Flicker
Address [2] 1438 0
Country [2] 1438 0
Secondary sponsor category [3] 1439 0
Individual
Name [3] 1439 0
A/Prof D. Jolley
Address [3] 1439 0
Country [3] 1439 0
Secondary sponsor category [4] 1440 0
Individual
Name [4] 1440 0
Dr L. Segal
Address [4] 1440 0
Country [4] 1440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3079 0
Monash University
Ethics committee address [1] 3079 0
Ethics committee country [1] 3079 0
Australia
Date submitted for ethics approval [1] 3079 0
Approval date [1] 3079 0
08/06/2006
Ethics approval number [1] 3079 0
2006/249

Summary
Brief summary
This study addresses the issue of disability among our ageing population. Preservation of function among our older citizens, and their capacity to live independently, is of significant social, public health and economic benefit. The aims of this study are to (1) test the efficacy of Tai Chi in delaying disability among older people, prior to its onset, (2) investigate the mechanisms by which Tai Chi intervenes in the disability pathway, (3) determine the cost-benefits of Tai Chi for older people. The study will recruit 500 people over 70 years of age and randomly assign them to receive either Tai Chi, or a stretching and relaxation program, for a period of 48 weeks. The groups will then be compared to determine if there is any difference in the development of disability as well as a range of functional outcomes such as strength, balance, depression, arthritic symptoms, life satisfaction, and falls.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27930 0
Address 27930 0
Country 27930 0
Phone 27930 0
Fax 27930 0
Email 27930 0
Contact person for public queries
Name 10512 0
Dr Wendy Watson
Address 10512 0
Building 70
Monash Univerrsity
Wellington Road
Clayton
VIC 3800
Country 10512 0
Australia
Phone 10512 0
03 9905 1813
Fax 10512 0
03 9905 1809
Email 10512 0
[email protected]
Contact person for scientific queries
Name 1440 0
Dr Lesley Day
Address 1440 0
Building 70
Monash Univerrsity
Wellington Road
Clayton
VIC 3800
Country 1440 0
Australia
Phone 1440 0
03 9905 1811
Fax 1440 0
03 9905 1809
Email 1440 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.