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Trial registered on ANZCTR


Registration number
ACTRN12613000010796
Ethics application status
Approved
Date submitted
23/12/2012
Date registered
4/01/2013
Date last updated
29/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tai Chi for Depression
Scientific title
A Randomized Controlled Trial of Tai Chi for Depression
Secondary ID [1] 281707 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health including depression, anxiety and stress 287999 0
Central obesity 288003 0
Condition category
Condition code
Mental Health 288379 288379 0 0
Depression
Metabolic and Endocrine 288380 288380 0 0
Other metabolic disorders
Diet and Nutrition 288414 288414 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A participants attended an intensive instructor-led tai chi/qigong exercise group-based training (3 sessions per week) during the first 6 months of intervention, followed by a less intensive training (1 session per week) during the following 6 months. Group B participants were placed on a waiting list during the first 6 months, followed by intensive instructor-led group tai chi/qigong training (3 sessions per week) during the second 6 months. All participants continued their treatment as usual during the study.

The exercise was adapted from the KaiMai tai chi style. Each group session lasted 1 to 1.5 hours with 10 minutes warm up, 45 minutes practice, and 10 to 25 minutes cooling down. The intensity of the exercise during each session varied among participants according to individual health and fitness levels.

The treatment as usual refers to that study participants continued to receive usual medical care from their doctors during the study period.
Intervention code [1] 286243 0
Lifestyle
Intervention code [2] 286244 0
Treatment: Other
Comparator / control treatment
Treatment as usual (participants continued to receive usual care from their doctors during the study period). Group B participants will be placed on a waiting list before commencing the intervention during the second 6 months.
Control group
Active

Outcomes
Primary outcome [1] 288551 0
Depressive symptoms (assessed by CES-D10 and Depression Anxiety Stress Scale 21 [DASS21]).
Timepoint [1] 288551 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.
Primary outcome [2] 288581 0
Anxiety (assessed by Depression Anxiety Stress Scale 21 [DASS21]).
Timepoint [2] 288581 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.
Primary outcome [3] 288582 0
Stress symptoms (assessed by Depression Anxiety Stress Scale 21 [DASS21]).
Timepoint [3] 288582 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.
Secondary outcome [1] 300451 0
Quality of life, assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey.

Timepoint [1] 300451 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months
Secondary outcome [2] 300501 0
Leg strength, assessed using a chair-stand test (number of stands completed in 30 seconds) modified from the US Senior Fitness Test (after the fasting blood measures test).
Timepoint [2] 300501 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.
Secondary outcome [3] 300503 0
Body mass index, calculated using the formula: Body mass index = weight (kg) / height (m)2.
Timepoint [3] 300503 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.
Secondary outcome [4] 300507 0
Waist circumference. The assessor stood in front of the participant Wo correctly locate the narrowing of the waist. The measurement was taken with an anthropometry measurement tape at the level of the narrowest point over the naked skin between the lower costal (rib) border and the iliac crest. Waist circumference was measured three times for each participant and results were recorded. The mean of the three measurements was taken as the final result.
Timepoint [4] 300507 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.
Secondary outcome [5] 300508 0
Blood pressure, each participant rested for at least 5 minutes prior to measurement, in a chair with their back supported. The left arm was bared and supported at heart level. The cuff was firmly wrapped around the left upper arm (or around the right upper arm if the first blood collection was conducted on the right arm) at heart level, measured three times for each participant and results were recorded. The mean of the three measurements was taken as the final result.
Timepoint [5] 300508 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.
Secondary outcome [6] 300509 0
Fasting blood glucose. Blood samples were obtained from each participant’s antecubital vein after an overnight fast for the determination of plasma glucose at the Princess Alexandra Hospital in Brisbane, Queensland, Australia.
Timepoint [6] 300509 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.
Secondary outcome [7] 300510 0
Fasting blood insulin. Blood samples were obtained from each participant’s antecubital vein after an overnight fast for the determination of serum insulin at the Princess Alexandra Hospital in Brisbane, Queensland, Australia.
Timepoint [7] 300510 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.
Secondary outcome [8] 300511 0
HbA1c. Blood samples were obtained from each participant’s antecubital vein after an overnight fast for the determination of HbA1c at the Princess Alexandra Hospital in Brisbane, Queensland, Australia.
Timepoint [8] 300511 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.
Secondary outcome [9] 300512 0
Lipids. Blood samples were obtained from each participant’s antecubital vein after an overnight fast for the determination of lipids at the Princess Alexandra Hospital in Brisbane, Queensland, Australia.
Timepoint [9] 300512 0
Assessed at induction screening, randomization baseline, and then at 3, 6, 9 and 12 months.

Eligibility
Key inclusion criteria
Eligibility criteria included age 18-80 years, depression (identified by GPs), being on antidepressants for depression or having a short form Center for Epidemiologic Studies Depression Scale 10 (CESD 10) rating score of 10 or higher, and having central obesity assessed by waist circumference (> 95 cm [men]; 80 cm [women]) and/or body mass index (> 30 kg/m2) using the definition of central obesity by the International Diabetes Federation.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included contraindications to physical activity, mental illness other than depression, such as diagnosed bipolar disorder and schizophrenia, severe or acute general medical problem, type 1 diabetes, current pregnancy, being within 3 months post-partum, or anticipating pregnancy during the course of the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286497 0
Charities/Societies/Foundations
Name [1] 286497 0
National Heart Foundation
Address [1] 286497 0
Level 12, 500 Collins Street, Melbourne, VIC 3000
Country [1] 286497 0
Australia
Funding source category [2] 286521 0
Charities/Societies/Foundations
Name [2] 286521 0
beyondblue
Address [2] 286521 0
PO Box 6100, Hawthorn West, VIC 3122, Australia.
Country [2] 286521 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 285285 0
None
Name [1] 285285 0
Address [1] 285285 0
Country [1] 285285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288573 0
Human Research Ethics Committee of the Princess Alexandra Hospital, in Brisbane
Ethics committee address [1] 288573 0
Building 35, Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba, Brisbane, QLD4102
Ethics committee country [1] 288573 0
Australia
Date submitted for ethics approval [1] 288573 0
Approval date [1] 288573 0
22/05/2009
Ethics approval number [1] 288573 0
2009/89
Ethics committee name [2] 288574 0
Human Research Ethics Committee of the University of Queensland
Ethics committee address [2] 288574 0
University of Queensland, St Lucia, QLD 4072
Ethics committee country [2] 288574 0
Australia
Date submitted for ethics approval [2] 288574 0
Approval date [2] 288574 0
22/05/2009
Ethics approval number [2] 288574 0
2009001092

Summary
Brief summary
The primary purpose of the study was to determine the effects of a tai chi/qigong exercise intervention program on variables associated with mental health, quality of life, leg strength and selected metabolic parameters in participants with depression and central obesity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36734 0
Dr Xin Liu
Address 36734 0
CC6, St John's College, University of Queensland, St Lucia, QLD4067, Australia
Country 36734 0
Australia
Phone 36734 0
+61 7 3176 6426
Fax 36734 0
Email 36734 0
xin.liu@uqconnect.edu.au;liu.xin@uq.edu.au
Contact person for public queries
Name 36735 0
Dr Xin Liu
Address 36735 0
CC6, St John's College, University of Queensland, St Lucia, QLD4067, Australia
Country 36735 0
Australia
Phone 36735 0
+61 7 3176 6426
Fax 36735 0
Email 36735 0
xin.liu@uqconnect.edu.au;liu.xin@uq.edu.au
Contact person for scientific queries
Name 36736 0
Dr Xin Liu
Address 36736 0
CC6, St John's College, University of Queensland, St Lucia, QLD4067, Australia
Country 36736 0
Australia
Phone 36736 0
+61 7 3176 6426
Fax 36736 0
Email 36736 0
xin.liu@uqconnect.edu.au;liu.xin@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary