Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000277448
Ethics application status
Approved
Date submitted
29/02/2016
Date registered
2/03/2016
Date last updated
16/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to assess the efficacy of Tai Chi for Type 1 Diabetes
Scientific title
A pilot study to assess the efficacy of Tai Chi for Type 1 Diabetes
Secondary ID [1] 288652 0
Y16GLIUX
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 297837 0
Condition category
Condition code
Metabolic and Endocrine 298010 298010 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a quasi randomized controlled trial. Participants with type 1 diabetes will be randomly allocated to the Tai Chi, or the usual medical care alone control group using a computer-generated randomization schedulebased on recruitment date. The recruitment of control group participants will be conducted after completion of recruitment of Tai Chi group participants. In addition to usual care, participants in the intervention groups (Group A) will have two supervised instructor-led group training sessions per week during the first three months of intervention; followed by self-led training during the remaining three months. Tai Chi group participants will receive a DVD/video tape demonstrating the Tai Chi program and will be encouraged to practice at home on days when they do not attend group sessions. Each Tai Chi session will last approximately 1 to 1.5 hours with 30 minutes warm up, 30 minutes practice, and 6 to 30 minutes cool down. During the second three months of follow up, Tai Chi group participants will have ‘free choice’ (‘self-led’ training) and are encouraged to organize their own group training, or practice at home. All participants will continue to receive medical usual care from their GPs throughout the study and receive a monthly phone call to encourage them to maintain their usual care and reduce drop-out from the study. The control group (Group B) will participate in the study during the first 3 months and attend baseline and 3 months assessments. The control group will be offered the Tai Chi program at the end of the study. .
Intervention code [1] 294068 0
Lifestyle
Intervention code [2] 294085 0
Treatment: Other
Comparator / control treatment
The control group is now a wait-list control group who will be offered the intervention after the 3 month study period.
Control group
Active

Outcomes
Primary outcome [1] 297524 0
*HbA1c (to give an indication of average blood glucose over the preceding 2 - 3
months).
Timepoint [1] 297524 0
Assess at baseline, 12 weeks and 24 weeks.
Primary outcome [2] 297525 0
*Depressive symptoms using CESD Depression Scale (CESD 10)
Timepoint [2] 297525 0
Assess at baseline, 12 weeks and 24 weeks.
Secondary outcome [1] 321387 0
Leg strength using a chair-stand test (number of stands completed in 30 seconds) modified from the US Senior Fitness Test.
Timepoint [1] 321387 0
For Tai Chi Group (Group A): Assess at baseline, 12 weeks and 24 weeks.
For Control Group (Group B): Assess at baseline and 12 weeks.
Secondary outcome [2] 321388 0
Health related quality of life (using SF36).
Timepoint [2] 321388 0
For Tai Chi Group (Group A): Assess at baseline, 12 weeks and 24 weeks.
For Control Group (Group B): Assess at baseline and 12 weeks.
Secondary outcome [3] 321389 0
Blood pressure: assessed by blood pressure monitor.
Timepoint [3] 321389 0
For Tai Chi Group (Group A): Assess at baseline, 12 weeks and 24 weeks.
For Control Group (Group B): Assess at baseline and 12 weeks.
Secondary outcome [4] 321390 0
Body mass index: weight and height are assessed by weight and measurement tape.
Timepoint [4] 321390 0
For Tai Chi Group (Group A): Assess at baseline, 12 weeks and 24 weeks.
For Control Group (Group B): Assess at baseline and 12 weeks.
Secondary outcome [5] 321391 0
Waist circumference: assessed by measurement tape.
Timepoint [5] 321391 0
For Tai Chi Group (Group A): Assess at baseline, 12 weeks and 24 weeks.
For Control Group (Group B): Assess at baseline and 12 weeks.
Secondary outcome [6] 321392 0
Lipids: assessed by blood samples.
Timepoint [6] 321392 0
For Tai Chi Group (Group A): Assess at baseline, 12 weeks and 24 weeks.
For Control Group (Group B): Assess at baseline and 12 weeks.
Secondary outcome [7] 321393 0
Changes in medication, in particular total daily dose of insulin, dose of BP lowering therapy, lipid lowering therapy and depression (using questionnaire). This is a composite secondary outcome using a questionnaire named "Changes in Medication" which is designed specifically for this study.
Timepoint [7] 321393 0
For Tai Chi Group (Group A): Assess at baseline, 12 weeks and 24 weeks.
For Control Group (Group B): Assess at baseline and 12 weeks.
Secondary outcome [8] 321394 0
Physical activity using a one week recall questionnaire adapted from the Active Australia Survey. The items have demonstrated acceptable test-retest reliability.
Timepoint [8] 321394 0
For Tai Chi Group (Group A): Assess at baseline, 12 weeks and 24 weeks.
For Control Group (Group B): Assess at baseline and 12 weeks.

Eligibility
Key inclusion criteria
type 1 diabetes with HbA1c of 7.5 - 10% on stable insulin therapy; aged 18 - 70 years; no health or injury problems that would prevent doing the exercises; able to attend intervention sessions 2 times per week for 12 weeks and 'self-led' training for a further 12 weeks; and living in Brisbane.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Contraindications for physical activity. Medical condition which contraindicates participation in physical activity as suggested by the American College of Sports Medicine 2000 (eg unstable angina, uncontrolled blood pressure > 200/110 mmHg, orthostatic hypotension > 20 mmHg, critical aortic stenosis, uncontrolled atrial or ventricular
arrythmia, uncontrolled sinus tachycardia, acute systemic illness or fever, moderate to severe heart failure, 3 degrees AV block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, resting ST segment displacement [>2mm]);
*Mental illness such as diagnosed bipolar disorder, schizophrenia etc (except depression).
*Currently pregnant or intending to become pregnant during the program;
*Existing pregnancy (or is within 3 months postpartum, or planning pregnancy in the next 12 months)
*Serious back, neck or knee problems
*A diagnosis of dementia, malignancy or life threatening disease
*Previous stroke, neurological or orthopaedic condition inhibiting exercise training
*Inability to complete the data collection forms or follow the program instructions

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This was a quasi randomized controlled trial. Participants with type 1 diabetes were randomly allocated to the Tai Chi or the usual medical care alone control group based on recruitment date. The recruitment of control group participants was conducted after completion of recruitment of Tai Chi group participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Based on recruitment date, participants with type 1 diabetes were quasi randomized to the Tai Chi or the usual medical care alone control group: the recruitment of control group participants was conducted after completion of recruitment of Tai Chi group participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
2/05/2016
Actual
2/05/2016
Date of last participant enrolment
Anticipated
28/05/2016
Actual
18/08/2016
Date of last data collection
Anticipated
Actual
13/11/2016
Sample size
Target
46
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5363 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 12816 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 293011 0
Charities/Societies/Foundations
Name [1] 293011 0
Diabetes Australia Research Trust
Country [1] 293011 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 291789 0
None
Name [1] 291789 0
Address [1] 291789 0
Country [1] 291789 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294522 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 294522 0
Metro South Health

TRI 37 Kent Street Woolloongabba QLD 4102
Ethics committee country [1] 294522 0
Date submitted for ethics approval [1] 294522 0
15/11/2015
Approval date [1] 294522 0
05/01/2016
Ethics approval number [1] 294522 0
HREC/15/QPAH/775
Ethics committee name [2] 294523 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 294523 0
St Lucia, Brisbane Queensland 4072
Ethics committee country [2] 294523 0
Australia
Date submitted for ethics approval [2] 294523 0
01/02/2016
Approval date [2] 294523 0
05/02/2016
Ethics approval number [2] 294523 0
2016000093

Summary
Brief summary
Type 1 diabetes affects 10 - 15 per cent of all people with diabetes. Based on the promising findings from our preliminary studies on the efficacy of Tai Chi for type 2 diabetes, the overall aim of the proposed project is to assess the effects of Tai Chi on type 1 diabetes. The proposed project is a two-group quasi randomized controlled trial. Participants with type 1 diabetes will be randomly allocated to the Tai Chi, or the usual medical care alone control group based on recruitment date. Metabolic/biochemical, physical, psychological, general health and well-being, and behavioral measures will be assessed at baseline, 3 and 6 months for intervention group and at baseline and 3 months for the control group. The main hypothesis of the project is that study participants with type 1 diabetes who receive the Tai Chi program will demonstrate improvements in indicators of glycaemic control, mental health and quality of life after 3 months of participation relative to participants who receive usual care alone over the same period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63998 0
Dr Xin Liu
Address 63998 0
The University of Queensland School of Medicine
Level 7, Translational Research Institute
37 Kent Street, Woolloongabba, QLD 4102
Country 63998 0
Australia
Phone 63998 0
+61 7 34437483
Fax 63998 0
Email 63998 0
[email protected]
Contact person for public queries
Name 63999 0
Dr Xin Liu
Address 63999 0
The University of Queensland School of Medicine
Level 7, Translational Research Institute
37 Kent Street, Woolloongabba, QLD 4102
Country 63999 0
Australia
Phone 63999 0
+61 7 34437483
Fax 63999 0
Email 63999 0
[email protected]
Contact person for scientific queries
Name 64000 0
Dr Xin Liu
Address 64000 0
The University of Queensland School of Medicine
Level 7, Translational Research Institute
37 Kent Street, Woolloongabba, QLD 4102
Country 64000 0
Australia
Phone 64000 0
+61 7 34437483
Fax 64000 0
Email 64000 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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