Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000528459
Ethics application status
Approved
Date submitted
10/10/2007
Date registered
12/10/2007
Date last updated
29/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chinese medical exercises for metabolic syndrome and diabetes control
Scientific title
The efficacy of Tai Chi and Qigong in reducing indicators of risk of Type 2 diabetes in adults with elevated blood glucose - A randomized controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
indicators of metabolic syndrome and diabetes control 2438 0
Condition category
Condition code
Metabolic and Endocrine 2541 2541 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participantes in Group A attened Tai Chi/Qigong exercise group training classed 3 times a week for 12 weeks followed by 12 week self-led 'at home' training. Participants in Group B had no intervention during the first 12 weeks (waiting period); this was followed by Tai Chi/Qigong group training classes 3 times a week for the next 6 weeks, followed by self-led 'at home' training during the remaining 6 weeks
Intervention code [1] 2166 0
Prevention
Intervention code [2] 2167 0
Treatment: Other
Comparator / control treatment
usual care (participants continued to receive usual care from their doctors during the 6 month study period).
Control group
Active

Outcomes
Primary outcome [1] 3445 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] 3445 0
Physical measurement conducted at baseline (after randominzation), 6 weeks, 12 weeks, 18 weeks and 24 weeks; haematological measurement conducted at baseline (after randomization), 12 weeks and 24 weeks.
Primary outcome [2] 3446 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] 3446 0
Assessed at baseline (after randomization), 12 weeks and 24 weeks
Secondary outcome [1] 5734 0
Changes in psychological measures including stress, depression, self-efficacy for physical activity, social support for physical activity
Timepoint [1] 5734 0
Assessed at baseline (after randominzation), 6 weeks, 12 weeks, 18 weeks and 24 weeks
Secondary outcome [2] 5735 0
Changes in indicators of strength, general health and well-being including leg strength, diabetic symptoms, quality of life
Timepoint [2] 5735 0
Assessed at baseline (after randominzation), 6 weeks, 12 weeks, 18 weeks and 24 weeks
Secondary outcome [3] 5736 0
Changes in behaviour measures including physical activity
Timepoint [3] 5736 0
Assessed at baseline (after randominzation), 6 weeks, 12 weeks, 18 weeks and 24 weeks

Eligibility
Key inclusion criteria
Elevated blood glucose (> 5.6 mmol/L) but not currently taking diabetes medication and not being on diabetes medication in the three months prior to the program.
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 6 or 12 consecutive weeks.

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)
After priliminary eligibility screening by telephone, potential participants were referred to GP for obtaining clearance to participate followed by randomization (prior to baseline assessment). Consent forms were obtained from all participants prior to baseline assessment. Central randomisation allocation was done by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was performed using a computer-generated randomisation schedule by a research assisstant
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 454 0
4072

Funding & Sponsors
Funding source category [1] 2688 0
Charities/Societies/Foundations
Name [1] 2688 0
Diabetes Australia Research Trust
Country [1] 2688 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 2432 0
None
Name [1] 2432 0
Address [1] 2432 0
Country [1] 2432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4609 0
Human Research Ethics Committee at the University of Queensland
Ethics committee address [1] 4609 0
University of Queensland, St Lucia, QLD 4072
Ethics committee country [1] 4609 0
Australia
Date submitted for ethics approval [1] 4609 0
Approval date [1] 4609 0
24/02/2005
Ethics approval number [1] 4609 0
HMS05/24/2

Summary
Brief summary
The primary purpose of the study was to determine the effects of a Tai Chi/Qigong intervention program on variables associated with metabolic syndrome and/or diabetes control, and on other psychological, general health, and physical activity variables.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28102 0
Address 28102 0
Country 28102 0
Phone 28102 0
Fax 28102 0
Email 28102 0
Contact person for public queries
Name 11259 0
Liu Xin
Address 11259 0
School of Human Movement Studies, the University of Queensland, St Lucia, QLD 4072
Country 11259 0
Australia
Phone 11259 0
07-33656463
Fax 11259 0
Email 11259 0
[email protected]
Contact person for scientific queries
Name 2187 0
Liu Xin
Address 2187 0
School of Human Movement Studies, the University of Queensland, St Lucia, QLD 4072
Country 2187 0
Australia
Phone 2187 0
07-33656463
Fax 2187 0
Email 2187 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.