Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000530426
Ethics application status
Approved
Date submitted
13/10/2007
Date registered
17/10/2007
Date last updated
29/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tai Chi and Qigong for metabolic syndrome and diabetes control
Scientific title
A pilot study on the efficacy, feasibility and acceptability of a Chinese medical exercise intervention program consisting of Tai Chi and Qigong in reducing indicators of risk of metabolic syndrome and Type 2 diabetes in adults with elevated blood glucose
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Indicators of metabolic syndrome and glycemic control. 2459 0
Condition category
Condition code
Metabolic and Endocrine 2557 2557 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants attended Tai Chi/Qigong group training classes for 1 to 1.5 hours 3 times a week for 12 weeks.
Intervention code [1] 2184 0
Prevention
Intervention code [2] 2185 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3463 0
Changes in indicators of metabolic syndrome including body mass index (BMI), waist circumference, blood pressure, fasting blood glucose, triglycerides and high density lipoprotein-cholesterol (HDL-C).
Timepoint [1] 3463 0
Assessed immediately prior to and after the intervention.
Primary outcome [2] 3464 0
Changes in other indicators of diabetes control including HbA1c, fasting insulin, 2 hour blood glucose, 2 hour blood insulin, total cholesterol, low density lipoprotein-cholesterol (LDL-C); and derived estimates from the blood glucose and insulin, including insulin resistance, metabolic clearance rate and beta cell function.
Timepoint [2] 3464 0
Assessed immediately prior to and after the intervention.
Secondary outcome [1] 5778 0
Changes in psychological measures including stress, depression, self-efficacy for physical activity, and social support for physical activity.
Timepoint [1] 5778 0
Assessed immediately prior to and after the intervention.
Secondary outcome [2] 5779 0
Changes in indicators of strength, general health and well-being including leg strength, diabetic symptoms, and quality of life.
Timepoint [2] 5779 0
Assessed immediately prior to and after the intervention.
Secondary outcome [3] 5780 0
Changes in behaviour measures including physical activity.
Timepoint [3] 5780 0
Assessed immediately prior to and after the intervention.

Eligibility
Key inclusion criteria
Had elevated blood glucose (> 5.6 mmol/L and < 7 mmol/L) but had not been diagnosed with type 2 diabetes, were living in the Brisbane area, were not on medication for blood glucose.
Minimum age
30 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical condition which contraindicates participation in physical activity as suggested by the American College of Sports Medicine 2000; unwilling or unable to attend three sessions/week for 12 consecutive weeks.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After priliminary eligibility screening by telephone, potential participants were referred to GP for obtaining clearance to participate. Consent forms were obtained from all participants prior to baseline assessment. This is a one group pre- and post intervention study, so no group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
11
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 277 0
4072

Funding & Sponsors
Funding source category [1] 2703 0
Charities/Societies/Foundations
Name [1] 2703 0
Diabetes Australia Research Trust
Country [1] 2703 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 2447 0
None
Name [1] 2447 0
Address [1] 2447 0
Country [1] 2447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4623 0
Human Research Ethics Committee at the University of Queensland
Ethics committee address [1] 4623 0
University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 4623 0
Australia
Date submitted for ethics approval [1] 4623 0
Approval date [1] 4623 0
24/02/2005
Ethics approval number [1] 4623 0
HMS05/24/2

Summary
Brief summary
To preliminarily evaluate the effects of the program on primary outcomes (indicators of metabolic syndrome and diabetes control), and to investigate the feasibility and acceptability of both the program and the methods to be used in the main study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28114 0
Address 28114 0
Country 28114 0
Phone 28114 0
Fax 28114 0
Email 28114 0
Contact person for public queries
Name 11271 0
Liu Xin
Address 11271 0
School of Human Movement Studies, the University of Queensland
St Lucia QLD 4072
Country 11271 0
Australia
Phone 11271 0
+61 7 33656463
Fax 11271 0
Email 11271 0
[email protected]
Contact person for scientific queries
Name 2199 0
Liu Xin
Address 2199 0
School of Human Movement Studies, the University of Queensland
St Lucia QLD 4072
Country 2199 0
Australia
Phone 2199 0
+61 7 33656463
Fax 2199 0
Email 2199 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.