Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000810910
Ethics application status
Approved
Date submitted
22/06/2011
Date registered
2/08/2011
Date last updated
2/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Tai Ji Quan on stress
Scientific title
The effect of six weeks of tai ji practice on anxiety in healthy but stressed people compared to an exercise only comparison group
Secondary ID [1] 262435 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 268125 0
Condition category
Condition code
Mental Health 268273 268273 0 0
Anxiety
Alternative and Complementary Medicine 268486 268486 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The taiji sessions will take place for the first six weeks and during these six weeks there will be five taiji
sessions per week (one hour each) available for participants to attend. It is required that participants must
complete at least five hours of taiji training a week (minimum 1800 minutes during the initial six weeks) and at least two of these must be in the contact sessions. The contact session will be conducted as a group with a trainer and non contact practice will self practice and monitored by a log book. There is no limit on how many contact taiji sessions any individual attends, but the minimum of two contact sessions must be completed per week. Remaining hours of taiji training (non contact) must be recorded in log book with reflections on each non contact practice to ensure sufficient hours are completed.
After the initial six weeks there will only be one contact session a week for the remaining six weeks to revise any forgotten movements and check completion of log books. The emphasis on home taiji practice (non contact) will be strongly reinforced and the minimum of five hours of taiji training a week still applies. Participants will be asked to follow the DVD they were given at the commencement of the trail in regards to the training.
Intervention code [1] 266809 0
Treatment: Other
Comparator / control treatment
This is a three arm study and the three groups are A: Tai Chi (intervention) B: Gym (active control) and C:Wait list (non active control).
The gym group (B) will be the active control group and they will be provided with gym membership for the
duration of the trial (twelve weeks). As with the intervention group they will be given a journal to log
the amount of time and frequency of their exercise. It is also expected that they complete a total of
five hours of exercise per week including at least two hours at the UTS Fitness Centre. The participants will be assessed by the staff at the UTS Fitness centre and will be required to attend at least one of the scheduled exercise classes inclusive in the two hours they spend at the UTS Fitness Centre. There will be a weekly meeting with this group to check progress of journals.

The waiting list (C) will form the non active control and will be idle for the twelve weeks of the trial; however they will be given six weeks of taiji practice and the DVD after the twelve weeks as appreciation for their involvement in this trial.
Control group
Active

Outcomes
Primary outcome [1] 268999 0
State/trait anxiety scale
Timepoint [1] 268999 0
Baseline (week 0), week 6, week 12
Secondary outcome [1] 276777 0
Blood pressure using automatic sphygmomanometry
Timepoint [1] 276777 0
Baseline (week 0), week 6, week 12
Secondary outcome [2] 279170 0
Heart rate variability using ECG
Timepoint [2] 279170 0
Baseline (week 0), week 6, week 12
Secondary outcome [3] 279171 0
PSS-14 (Perceived Stress Scale 14 Questions
Timepoint [3] 279171 0
Baseline (week 0), week 6, week 12
Secondary outcome [4] 279172 0
Quality of Life using SF36 (Short Form 36 questions)
Timepoint [4] 279172 0
Baseline (week 0), week 6, week 12
Secondary outcome [5] 279173 0
Visual Analogue Scale (VAS) to assess perceived stress level
Timepoint [5] 279173 0
Baseline (week 0), week 6, week 12

Eligibility
Key inclusion criteria
Participants must be 18-60 years of age and have no serious medical conditions (Screened using the
Lifestyle Appraisal Questionnaire
Must be able to understand and sign the consent form
Score above 50 points on the State Trait Anxiety Inventory
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently training or have trained taiji in the last 12 months
Currently exercising on a regular basis
Any serious medical condition

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)
Once screened and consent form signed, partipants will be allocated an ID number Permutated blocks will be used to allocated individuals to one of the three groups. ID number will be sent to an off site individual who will randomly allocated particpants. The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed if it was done by the off site individual using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permutated blocks will be used to randomise particpants to one of three groups. An envelop method will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267282 0
Self funded/Unfunded
Name [1] 267282 0
Country [1] 267282 0
Australia
Primary sponsor type
University
Name
University of Technology, Sydney
Address
Building 4 Faculty of Science, Broadway campus Broadway 2007 NSW
Country
Australia
Secondary sponsor category [1] 266344 0
None
Name [1] 266344 0
Address [1] 266344 0
Country [1] 266344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269276 0
University of Technology, Sydney Human Research Ethics Comnmittee
Ethics committee address [1] 269276 0
PO Box 123 Broadway 2007 NSW
Ethics committee country [1] 269276 0
Australia
Date submitted for ethics approval [1] 269276 0
12/04/2011
Approval date [1] 269276 0
21/04/2011
Ethics approval number [1] 269276 0
HREC Number 2011-107A

Summary
Brief summary
Tai Ji or Tai Chi (TC) is an ancient Chinese mind body exercise that is practised worldwide by millions of people daily with the belief that it has the potent healing effects upon the practitioner and a fundamental path for longevity. Whilst the mechanisms behind TC are not fully understood it is a general consensus among the general population that TC calms the mind and benefits health. There has been growing interest in the scientific community to evaluate the efficacy of TC in various physiological and psychological conditions; in particular the therapeutic effects of TC in psychological conditions.
This study will hope to evaluate whether TC can improve stress level as measured by the State/trait anxiety scale and several objective physiological measures such as blood pressure, heart rate variability and galvanic skin response in a clinical trial with thirty participants.
The participants will be randomly allocated by computer to three equal sized groups (n=10 per group), the TC intervention group, Gym group and Waiting list. The TC intervention group will complete five hours of TC exercise per week (minimum 2 contact hours with the instructor) over a period of 6sixweeks and followed by six weeks of self practise. The gym group will receive 12 weeks of free gym membership at the UTS Fitness centre, whilst the waiting list forms the non-active control group. The waiting list group will however be given six weeks of TC class after the experimental period as thanks for participation in the trial.

The primary aim of this study is to evaluate if six weeks of TC practise can significantly reduce levels of stress in healthy but stressed individuals compared to a waiting list and if TC practise is equivalent to standard exercise in controlling stress levels. The trial will also evaluate if the effects of TC practise on stress can also be sustained when individuals are asked to practise without guidance and the comparative results of this compared to both waiting list and standard exercise groups. The primary measure will be the State/trait anxiety inventory and secondary measures will be blood pressure, SF36 (Short Form 36 questions to assess general health status), heart rate variability and a Visual Analogue Scale (VAS) on their perceived level of stress.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32768 0
Address 32768 0
Country 32768 0
Phone 32768 0
Fax 32768 0
Email 32768 0
Contact person for public queries
Name 16015 0
Mr Shuai Zheng
Address 16015 0
room 44 level 3 Building 4
City campus
University of Technology, Sydney 2007
New South Wales
Country 16015 0
Australia
Phone 16015 0
+ 61 2 9514 1780
Fax 16015 0
Email 16015 0
[email protected]
Contact person for scientific queries
Name 6943 0
Associate Professor Chris Zaslawski
Address 6943 0
Science Building,
University of Technology, Sydney- City Campus,
Corner of Harris and Thomas Street
Broadway 2007
New South Wales
Country 6943 0
Australia
Phone 6943 0
+61 2 95147856
Fax 6943 0
Email 6943 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

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