Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000715673
Ethics application status
Approved
Date submitted
4/11/2005
Date registered
4/11/2005
Date last updated
4/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health benefits of Tai Chi for older people with type 2 diabetes
Scientific title
Health benefits of Tai Chi for older people with type 2 diabetes: a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 865 0
Condition category
Condition code
Metabolic and Endocrine 932 932 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tai Chi - 2 x 1 hour classes per week for 4 months. All classes are supervised and led by an instructor.
Intervention code [1] 750 0
None
Comparator / control treatment
Sham exercise (gentle stretching and calisthenics) - 2 x 1 hour classes per week for 4 months. All classes are supervised and led by an instructor.
Control group
Placebo

Outcomes
Primary outcome [1] 1220 0
Insulin resistance (HOMA2)
Timepoint [1] 1220 0
Measured at baseline before randomisation and after 4 months (follow up)
Primary outcome [2] 1221 0
HbA1c
Timepoint [2] 1221 0
Measured at baseline before randomisation and after 4 months (follow up)
Secondary outcome [1] 2216 0
Body composition
Timepoint [1] 2216 0
Measurements performed at baseline and follow up
Secondary outcome [2] 2217 0
Mobility
Timepoint [2] 2217 0
Measurements performed at baseline and follow up
Secondary outcome [3] 2218 0
Physical function
Timepoint [3] 2218 0
Measurements performed at baseline and follow up
Secondary outcome [4] 2219 0
Muscle performance
Timepoint [4] 2219 0
Measurements performed at baseline and follow up
Secondary outcome [5] 2220 0
Balance
Timepoint [5] 2220 0
Measurements performed at baseline and follow up
Secondary outcome [6] 2221 0
Quality of life
Timepoint [6] 2221 0
Measurements performed at baseline and follow up
Secondary outcome [7] 2222 0
Attitudes towards diabetes
Timepoint [7] 2222 0
Measurements performed at baseline and follow up
Secondary outcome [8] 2223 0
Habitual physical activity
Timepoint [8] 2223 0
Measurements performed at baseline and follow up
Secondary outcome [9] 2224 0
Food intake
Timepoint [9] 2224 0
Measurements performed at baseline and follow up

Eligibility
Key inclusion criteria
Type 2 diabetesSedentaryAmbulatory without assistanceNo condition which would have precluded the planned exercises.
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation program, performed by researcher otherwise not involved with study subjects. Stratified by gender.
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
Completed
Date of first participant enrolment
Anticipated
1/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1029 0
University
Name [1] 1029 0
university of Sydney - school of exercise and sport science
Country [1] 1029 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Douglass Hanly Moir Pathology
Address
Country
Australia
Secondary sponsor category [1] 893 0
None
Name [1] 893 0
(N/A)
Address [1] 893 0
Country [1] 893 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36062 0
Address 36062 0
Country 36062 0
Phone 36062 0
Fax 36062 0
Email 36062 0
Contact person for public queries
Name 9939 0
Tracey Tsang
Address 9939 0
32 White Cedar Dr
Castle Hill NSW 2154
Country 9939 0
Australia
Phone 9939 0
+61 2 98948003
Fax 9939 0
Email 9939 0
[email protected]
Contact person for scientific queries
Name 867 0
Tracey Tsang
Address 867 0
32 White Cedar Dr
Castle Hill NSW 2154
Country 867 0
Australia
Phone 867 0
+61 2 98948003
Fax 867 0
Email 867 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.