Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000008527
Ethics application status
Approved
Date submitted
28/12/2005
Date registered
4/01/2006
Date last updated
4/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Tai Chi for Diabetes
Scientific title
A randomized controlled trial assessing the effectiveness of Tai Chi on cardiovascular risk factors for people with type 2 diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 969 0
Condition category
Condition code
Metabolic and Endocrine 1043 1043 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tai Chi for 6 months.
Comparator / control treatment
Usual care for 6 months.
Control group
Active

Outcomes
Primary outcome [1] 1393 0
HbA1c
Timepoint [1] 1393 0
Measured at baseline (before randomisation) and after 6 months.
Primary outcome [2] 1394 0
HOMA
Timepoint [2] 1394 0
Measured at baseline (before randomisation) and after 6 months.
Primary outcome [3] 1395 0
Blood pressure
Timepoint [3] 1395 0
Measured at baseline (before randomisation) and after 6 months.
Primary outcome [4] 1396 0
Health-related quality of life
Timepoint [4] 1396 0
Measured at baseline (before randomisation) and after 6 months.
Secondary outcome [1] 2463 0
Strength
Timepoint [1] 2463 0
Measured at baseline (before randomisation) and after 6 months.
Secondary outcome [2] 2464 0
Body composition (% fat)
Timepoint [2] 2464 0
Measured at baseline (before randomisation) and after 6 months.
Secondary outcome [3] 2465 0
Balance
Timepoint [3] 2465 0
Measured at baseline (before randomisation) and after 6 months.

Eligibility
Key inclusion criteria
Type 2 diabetes, diagnosed by doctor. Baseline HbA1c of 7.5 or above.
Minimum age
30 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Co-morbidity precluding participation in moderate exerciseUnwilling to accept randomisationEnrolled in formal/specific exercise programmes.

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)
Randomisation will be performed by a researcher who is not involved with the testing of subjects. Subjects will be informed of their group allocation by researchers not otherwise involved with the testing or training of them.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a centralized off-site computer-generated randomisation schedule, by a researcher otherwise not involved with the training or testing of the subjects.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1141 0
Government body
Name [1] 1141 0
St George GP division
Country [1] 1141 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Mayne Health
Address
Country
Australia
Secondary sponsor category [1] 998 0
None
Name [1] 998 0
(N/A)
Address [1] 998 0
Country [1] 998 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35882 0
Address 35882 0
Country 35882 0
Phone 35882 0
Fax 35882 0
Email 35882 0
Contact person for public queries
Name 10006 0
Dr Sarah Dennis
Address 10006 0
Senior Research Fellow
School of Public Health and Community Medicine
University of NSW
General Practice Unit, Fairfield Hospital
PO Box 5, Fairfield NSW 1860
Country 10006 0
Australia
Phone 10006 0
+61 2 9616 8519
Fax 10006 0
+61 2 9616 8400
Email 10006 0
[email protected]
Contact person for scientific queries
Name 934 0
Dr Sarah Dennis
Address 934 0
Senior Research Fellow
School of Public Health and Community Medicine
University of NSW
General Practice Unit, Fairfield Hospital
PO Box 5, Fairfield NSW 1860
Country 934 0
Australia
Phone 934 0
+61 2 9616 8400
Fax 934 0
Email 934 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.