J Acupunct Meridian Stud 2014;7(3):159e165

Available online at www.sciencedirect.com

Journal of Acupuncture and Meridian Studies

journal homepage: www.jams-kpi.com

- PROTOCOL -

Protocol: The Effect of 12 Weeks of Tai Chi

Practice on Anxiety in Healthy but Stressed
People Compared to Exercise and Wait-list
Comparison Groups: A Randomized
Controlled Trial
Shuai Zheng 1,*, Sara Lal 1, Peter Meier 1, David Sibbritt 2,
Chris Zaslawski 1
1

School of Medical and Molecular Biosciences, Faculty of Science, University of Technology,

Sydney, Australia
2
Faculty of Health, University of Technology, Sydney, Australia
Available online 11 February 2014

Received: Nov 13, 2013

Revised: Jan 10, 2014
Accepted: Jan 14, 2014
KEYWORDS
anxiety;
clinical trial;
mental health;
mindebody exercise;
psychological stress;
randomized control
trial;
Tai Chi

Abstract
Stress is a major problem in todays fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mindebody exercise of Tai Chi may provide an
alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi
group is superior to a wait-list control group in improving stress coping levels. This study is
a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi
practice against standard exercise and a Tai Chi group against a nonactive control group
over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants
(aged 18e60 years) who are either Tai Chi nave or have not practiced Tai Chi in the past
12 months will be randomized into a Tai Chi group (n Z 24), an exercise group (n Z 24) or
a wait-list group (n Z 24). The primary outcome measure will be the State Trait Anxiety

* Corresponding author. School of Medical and Molecular Biosciences, Faculty of Science, University of Technology, Sydney, P.O. Box 123,
Broadway, 2007 New South Wales, Australia.
E-mail: Shuai.Zheng@uts.edu.au (S. Zheng).
Copyright 2014, International Pharmacopuncture Institute
pISSN 2005-2901 eISSN 2093-8152
http://dx.doi.org/10.1016/j.jams.2014.01.003

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S. Zheng et al.
Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart
rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol
is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items.

1. Introduction
Stress is a major problem affecting the health of many individuals in todays society. The World Health Organization
states that mental problems, such as stress will probably
become the second most common disability by the year
2020 [1]. According to the Australian Institute of Health and
Welfare, 2169 hospital episodes in psychiatric hospitals in
Australia in 2001e2002 were for neurotic, stress-related,
and somatoform disorders [2]. Furthermore, a poll
recently conducted in 2011 by Lifeline, a nongovernment
organization, showed that 93% of Australians were stressed,
up from 90% in 2010. In addition, a similar survey conducted
by the Australian Psychological Society [3] in 2011 also
found that 12% of Australians reported experiencing stress
in the severe range, with one in three Australians reporting
that they were suffering from depressive symptoms, and
one in four from anxiety.
Patients with severe anxiety are generally treated with
pharmaceutical medications, psychotherapy, or a combination of both [4]; however, prior to treatment being
administered careful diagnoses must be undertaken, which
could present as a social stigma for healthy individuals who
have not yet developed pathological or somatoform anxiety
conditions. This may partially explain why people with
anxiety are also beginning to explore complementary and
alternative options for treating their anxiety, with one such
option being Tai Chi.
Taiji or Tai Chi (TC), as it is more commonly known
outside of Asia, is an ancient Chinese mindebody exercise
that is practiced worldwide by millions of people daily with
the belief that it has potent healing effects upon the
practitioner and is a fundamental path for longevity [5].
Although the mechanisms behind TC are not fully understood, it is purported that TC calms the mind and benefits
health [5]. More recently, there has been growing interest
in the scientific community to evaluate the efficacy of TC
for various physiological and psychological conditions
ranging from fear of falling in the elderly [6e8], balance
[9e11], metabolic disorders [12e14], arthritis [7,15e20] to
psychological health [13,21,22].
The recent reporting in 2011 of eight clinical trials
investigating anxiety and two investigating stress reflect
the growing interest in the use of TC for psychological
conditions [21]. However, these studies showed mixed results. More recently, a systematic review of the effects of
TC on psychological well-being appraised 40 clinical trials
conducted between March 2009 and May 2010 with a total
of 3817 participants [23]. The authors concluded that TC
significantly decreased anxiety levels [effect size
(ES) Z 0.66; 95% confidence interval (CI Z 0.29, 1.03),
reduced depression (ES Z 0.56; 95% CI Z 0.31, 0.80) and
significantly improved mood (ES Z 0.45; 95% CI Z 0.20,
0.69). Despite this conclusion, the claim that TC benefits

psychological well-being is still contentious because many

of the reported studies were poorly designed and lacked
statistical power [23].
The trial described in this protocol will evaluate whether
TC can enhance stress coping mechanisms by reducing
levels of stress-related anxiety as measured by the State
Trait Anxiety Inventory (STAI) [24]. Furthermore, the
Perceived Stress Scale 14 and the physiological measures of
blood pressure and heart rate variability will measure
changes to generalized stress levels.
This protocol has been developed using the 2013 Standard Protocol Items: Recommendations for Interventional
Trials (SPIRIT) [25] with SPIRIT item numbers included in
parentheses where appropriate.
(SPIRIT items 6a and 7)

2. Hypothesis
This study is designed to test two hypotheses: (1) TC is
statistically noninferior to exercise in moderatingstress;
and (2) TC is statistically superior to doing nothing (nonactive wait-list control) in moderating stress.
The study design also allows for further comparisons to
be made for both within- and between-group changes,
namely to assess if supervised TC practice performs as well
when unsupervised as well as how unsupervised TC practice
compares to both the exercise and wait-list groups at 12
weeks.
(SPIRIT item 7)

3. Methods and design

The design is a prospective parallel three-arm randomized
controlled trial with repeated measures. Participants will
be randomly allocated to three equally sized groups,
comprising a TC intervention group, an exercise group and a
wait-list group. The TC intervention group will be the primary intervention group with the exercise group acting as
an active comparison group and the wait-list group as the
nonactive control group. The use of a three-arm design is to
differentiate between the benefits of physical movements
and the mindebody aspects unique to TC. The wait-list
group controls for regression to the mean and other timetied factors.
(SPIRIT items 6b and 8)

4. Participant recruitment
Individuals will be recruited from the general Sydney
metropolitan area in Australia through various media advertisements. General information will be provided on both
posters and in e-mails sent to interested participants. Individuals who are interested will be asked to reply to a

Tai Chi practice versus exercise and wait-list comparison groups

specific e-mail account created for screening purposes, and
an e-mail response containing additional information on
inclusion and exclusion criteria will be sent. Those individuals who potentially meet the given criteria will be
screened in person to determine eligibility.
Potential participants who meet the screening criteria will
be required to complete the Lifestyle Appraisal Questionnaire
(LAQ) [26] and the STAI [24] to determine if they fulfill the
requirements for the study. The LAQ assesses health risks and
perceived stress of participants and asks questions regarding
smoking habits, family history of severe medical conditions,
current medical conditions if any, medication use and serves
to identify if potential participants are suitable for the study
in terms of physical, mental and social health [26]. A cut-off
score of 50 in the STAI was selected because this would
place participants in the 90th percentile or higher as
stressed [27]. Those participants who qualify for inclusion
will have the trial explained to them in detail and informed
consent will be obtained prior to commencing the trial. Participants will also be asked to sign a declaration stating that
they will participate fully to the best of their ability and will
continue their involvement in the TC program once
commenced. A log book will be given to each participant to
monitor involvement and home practice of either TC or exercise as well as any reporting of adverse events.

4.1. Inclusion criteria

The inclusion criteria are: (1) between 18 and 60 years of
age with no serious medical conditions, screened using the
LAQ [26]; (2) must be English literate and able to read and
sign the consent form; and (3) score above the threshold of
50 on the STAI [27].

4.2. Exclusion criteria

The exclusion criteria are: (1) currently suffering from a
major illness; (2) currently taking antidepressant medication; (3) currently training or have trained in Tai Chi in the
past 12 months; (4) currently exercising on a regular basis
(greater than 5 hours of exercise per week on a regular
basis); and (5) currently pregnant.
(SPIRIT items 10, 11c, 15, 18b, 22 and 26a)

5. Data collection location

All participants will be recruited from the Sydney region and
all outcome measures will be collected on the Sydney city
campus of the University of Technology, Sydney (UTS). The
TC sessions will be conducted at the University of Technology, and at least 2 hours of exercise per week for the exercise group will be completed at the UTS Fitness Center.
(SPIRIT item 9)

6. Ethical considerations
This trial has the UTS Human Research Ethics Committee
approval (HREC 2011-107A) and is registered with Australian
New Zealand Clinical Trial Registry (ACTRN12611000810910).
(SPIRIT items 2a and 24)

161

7. Intervention
7.1. Tai Chi rationale
TC is believed to enhance mood and improve psychological
well-being. Although stress is generally nonpathological in
nature, an inability to cope with an increase of stress may
lead to pathological psychosomatic presentations, which are
commonly self-reported as feeling stressed. Feeling
stressed is becoming more prevalent in modern society
affecting both the healthy and the sick [23]. Past research
has shown that TC practice has significantly reduced both
trait anxiety and state anxiety from baseline after a 12-week
TC trial [28]; however, there are very few trials which use the
STAI as a primary measure for conducting TC research on
stress. For this trial, the simplified 24 stance Taiji Quan is
chosen as the TC intervention. Although there are various
other styles of TC (i.e., Chen, Yang, Sun, Wu), the simplified
24 stance Taiji Quan was chosen for its simplicity and ease of
learning [5]. This style was also chosen because it is the most
well-known form of TC internationally [5] and provides the
participants access to self-research materials in terms of
books and internet video clips.

7.2. Tai Chi instruction method

The TC sessions will involve group practice with instruction
given in both verbal and visual form to demonstrate both
the movements and the basic theory behind each action.
The TC component will be taught in sets of movements and
will, over the period of the trial, accumulate into the entire
24 stance form.
Each TC session will consist of 10 minutes of warm up, 45
minutes of TC practice and 5 minutes of cooling down. The
TC will be led by a skilled instructor who has been practicing TC for more than 15 years. The TC practice component will consist of TC meditative stance for 10 minutes
followed by the set of progressive movements each session.
A DVD of the 24 stance sequence will be given to each
participant of the TC group to encourage home practice and
act as a prompt in case the participant fails to remember a
movement during home practice. The DVD consists of the
instructor completing the entire TC set to ensure that
movements are exactly identical to the face-to-face TC
session.
During this time participants may continue their normal
lifestyles (based on the initial inclusion criteria that they
were not exercising on a regular basis) and to not
commence any regular exercise regime or participate in
other mindebody exercises, such as yoga or qigong.
A log book will be given to each participant to record
practice times and home practice will be reinforced by
writing reflective entries on their practice and thoughts on
various stances in the TC form as well as recording any
adverse events.
(SPIRIT items 11a and 11d )

7.3. Tai Chi dosage

TC sessions will take place initially during first 6 weeks and
during this period there will be five TC sessions (1 hour

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S. Zheng et al.

each) each week available for participants to attend. It is

required that participants must complete at least 5 hours of
TC a week (minimum 1800 minutes during the initial 6
weeks) and at least two of these must be face-to-face
sessions with the instructor. There is no restriction on how
many TC sessions any individual attends, but the minimum
two must be completed. Remaining sessions will be recorded in the log book to ensure sufficient hours are
completed.
The 6 weeks only of face-to-face instructions is designed
to assess if the efficacy of TC is limited only to the condition
that participants must have an instructor present or if the
efficacy of TC will be reflected and maintained through
self-directed practice. This can potentially lead to selfempowerment of participants without the need to attend
specific classes once the basics of TC have been learnt.
Home practice will be expected throughout the 12
weeks (6 weeks contact and 6 weeks noncontact) and will
be reinforced by logging time and frequency of practice.
The total minimum dosage of TC practice for the 12 weeks
is 3600 minutes with 720 minutes of face-to-face class time.
Study staff will contact participants via e-mail during the
study to maximize adherence to protocol, especially during
the last 6 weeks of noncontact TC.

10. Adverse events and discontinuation from

the study

8. Active controls

12. State Trait Anxiety Inventory

The exercise group will be an active control group and they

will be provided with gym membership for the duration of
the trial (12 weeks), and during the study participants in
this group will be asked not to undertake any form of
mindebody exercises.
As with the intervention group, they will be given a log
book to record the amount of time spent, frequency and
type of exercise undertaken, as well as recording any
adverse event. It is also expected that they complete a
total of 5 hours of exercise per week including at least 2
hours at the UTS Fitness Center. The participants will be
assessed by the staff at the UTS Fitness Center and will be
required to attend at least one of the scheduled exercise
classes inclusive in the minimum 2 hours they are required
to spend at the UTS Fitness Center. The total dosage for the
active control group is also 3600 minutes with a total of 720
minutes of face-to-face class time over the period of 12
weeks similar to the TC group. This arm will control for
attention and exercise equivalence.

The STAI consists of two subtests which collect subjective

data from participants on their State and Trait Anxiety in
the form of two questionnaires consisting of 20 questions
each [24]. The State Anxiety (Y-1) section is designed to
assess an individuals reaction to stress and their emotional
state at a particular time, whereas Trait Anxiety (Y-2) is
related to an individuals personality trait and how they
perceive stress [27]. The questions require the participant
to rank their current and general feelings towards certain
statements between four options of increasing frequency
ranging from almost never to almost always.
The STAI is a highly reliable measure for both stress and
anxiety, which is also reflected by internal consistency a
coefficients ranging from 0.87 to 0.92 for Y-1 and 0.89 to
0.90 for Y-2 [27].

9. Nonactive controls
The nonactive control group involves a wait-list group. The
wait-list group will be idle for the 12 weeks of the trial;
during this time, participants may continue their normal
lifestyles (based on the initial inclusion criteria that they
were not exercising on a regular basis) and are requested
not to commence any regular exercise regime or participate in other mindebody exercises, such as yoga or qigong.
At the completion of the study they will be given the
same 6 weeks of TC practice and DVD after the 12 weeks as
appreciation for their involvement. This group will control
for time-tied factors.

Participants will be asked to record any adverse events in

the log books and will be asked to withdraw from the study
if: (1) due to any physical ailments or injury they are unable
to complete the study; or (2) stress in participants is unmanageable without medical intervention.
(SPIRIT items 11b and 22)

11. Outcome measures

The trial will measure the level of anxiety in healthy but
stressed individuals with the STAI as the primary measure.
Secondary measures are PSS-14 (Perceived Stress Scale
14 Questions), heart rate variability (HRV), blood pressure
(BP), Short Form 36 Health Survey (SF36) and a Visual
Analog Scale (VAS).
All outcome measurements will be taken at three points
in time, prior to the commencement of the intervention
phase (week 0), at the completion of contact intervention
(week 6) and at the conclusion of the study (week 12).
(SPIRIT items 12, 13 and 18a)

13. Perceived Stress Scale 14

The PSS-14 is a 14 question instrument requiring participants to rank the frequency in which they felt or thought
about various statements with response descriptors ranging
from never to very often [29]. The questions are
designed to measure perceived stress and the coefficient a
reliability for the PSS-14 ranges from 0.84 to 0.86 [29].

14. Heart rate variability

HRV will be assessed because anxiety generally influences
these cardiac parameters adversely. Individuals experiencing anxiety symptoms have elevated levels of circulating
cortisol, controlled by the hypothalamicepituitaryeadrenal
axis. Cortisol is known to elevate sympathetic nervous system activity [30]. Although results on anxiety effects on HRV

Tai Chi practice versus exercise and wait-list comparison groups

are variable, most indicate a reduction in the high frequency
component of HRV or total HRV due to anxiety [31e33].
For the measurement of HRV, a three electrode electrocardiogram (ECG) will be obtained using the Flexcomp
Infinity (Thought Technology Ltd, model SA7550, Montreal
West, Quebec, Canada). ECG will be analyzed to derive HRV
measures. The two active ECG electrodes will be placed
level in the fourth intercostal space, approximately 2 cm
lateral to the sternum. The reference electrode will be
placed on the left shoulder [34]. A three lead ECG is sufficient to obtain the R-R measures required for HRV analysis
[35].
HRV provides a measure of sympathetic (low frequency)
and parasympathetic (high frequency) activities of the
autonomic nervous system [36]. The entire area under the
HRV spectrogram also provides a measure of total HRV.
Sympathovagal balance, a measure of the equilibrium between the sympathetic and parasympathetic arms, can also
be derived as a ratio of low frequency to high frequency
activity [37].
Participants will be required to fast from food and
caffeinated beverages (4 hours) and alcohol (24 hours) prior
to the collection of HRV data to reduce possible confounders that may affect results. The ECG for the HRV will
be obtained for 10 minutes at each data collection session
with the participant in a seated position with limited contact with the technician.
Low frequency activity, high frequency activity, total HRV
activity and sympathovagal balance will be analyzed to identify the effects of the intervention compared across the three
arms. This will provide a measure of change in autonomic
activity prior to and after the entire experimental phase.

15. Blood pressure

BP will be taken as anxiety increases peripheral BP and has
been shown to do so in studies [38e40]. BP will be taken
using a digital sphygmomanometer (A&D Medical, model
UA-851, Tokyo, Japan). Systolic (SP) and diastolic (DP) BP
will be taken a total of six times per data collection period,
three times prior to conducting HRV and three times after.
Individual systolic and diastolic data will be collected and
from it the mean arterial pressure will be estimated using
the following formula [41]:
Mean arterial pressure z DP (SP-DP)/3.

16. Short Form 36 Health Survey

The SF36 Health Survey (English version) is a commonly
used generic health questionnaire for adults which measures eight domains of health comprising physical functioning, role e physical, bodily pain, general health,
vitality, social functioning, role e emotional and mental
health [42]. This questionnaire includes 36 main questions
which contain several subset questions, with questions
relating to the various domains nested into the instrument
with the deliberate intention that the participant will need
to carefully read and assess each question prior to
responding [42]. Because there is no common consensus on
stress stimuli [43], various factors which affect the quality
of life of participants can contribute directly or indirectly

163

to perceived stress and the ability to cope with stress. This

demonstrates the need to collect holistic data from participants regarding their quality of life.
The reliability of the different domains are 0.93 for
physical functioning, 0.89 for role e physical, 0.90 for
bodily pain, 0.81 for general health, 0.86 for vitality, 0.68
for social functioning, 0.82 for role e emotional and 0.84
for mental health [42].

17. Visual Analog Scale

The VAS consists of a 100 mm line with the terms not
stressed at all and very stressed on either ends of the
line. The participant will be asked to mark on the VAS their
current stress levels.

18. Sample size and randomization

Sample size required is 42 participants, with 14 individuals
equally and randomly allocated to each group. The sample
size is based on Y-1 results of the pilot study completed in
2011 (difference of means from baseline to week 12 between TC and wait-list groups Z 17.143, standard
deviation Z 5.96) and will provide a power of 0.8. Similarly
with a noninferiority limit of 10 for Y-1, based on standard
deviation for norm scores [27], the minimum sample size
requirement is 11 per group at a power of 0.8 (difference of
means from baseline to week 12 between TC and active
control groups Z 6.17 standard deviation Z 9.02). To account for drop-outs or loss to follow-up, the sample size
needs to be inflated by 30% (based on pilot data) resulting
in 57 participants needing to be recruited (n Z 19 individuals per group).
The randomization process will be conducted by a third
party not involved in the study. The third party will employ
the sealed envelope method to randomize participants
(sealed opaque envelopes which contain the allocation information written on a piece of folded paper which is not
visible when held up to a light source) in permutated blocks
of six.
(SPIRIT items 16a, 16b)

19. Data management and statistical analysis

All personal information from participants will be deidentified and coded. Data will be entered by outcome
assessors and analyzed by a blinded data analyst.
This will be an intention to treat study and participants
who either drop out from the study or fail to adhere to the
protocol will have their last known data carried forward.
The statistical method will be a two-way analysis of
variance with repeated measures followed by Bonferronis
post-hoc test.
(SPIRIT items 19, 20a and 20c)

20. Timeline
Participants who meet the inclusion criteria will be evaluated using the outcome measures prior to the commencement of the trial, at the completion of the contact

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S. Zheng et al.

intervention (end of Week 6) and at the completion of the

trial (Week 12). After this time the wait-list participants
will take part in 6 weeks of TC practice, which will not be
included in the trial data, as appreciation for their participation in this trial.
(SPIRIT item 13)

The SPIRIT statement forms a guide for the content

required for reporting a clinical trial protocol [25]; however, not all 33 items were covered in this protocol due to
the limitations in reporting. This study design has fulfilled
and reported the relevant SPIRIT items for both the study as
well as the medium for reporting.

21. Discussion

Disclosure statement

This trial will investigate the efficacy of TC on anxiety in

healthy individuals implementing three parallel arms and
using the STAI as the primary measure. The trial design
seeks to test the clinical efficacy of TC both as an intervention administered to an individual under guidance as
well as to evaluate if the results can be sustained without
the ongoing assistance and supervision of an instructor.
The STAI was chosen as the primary outcome measure
because it is a highly reliable measure for both stress and
anxiety, which is also reflected by internal consistency a
coefficients ranging from 0.87 to 0.92 for State Anxiety and
0.89 to 0.90 for Trait Anxiety [27]. The importance of the
relationship between State and Trait Anxiety to an individual
is vital for an individuals ability to cope with stress as an
individuals Trait Anxiety can very well determine the ability
to respond to and influence the intensity of a State Anxiety
reaction [27]. This is because State Anxiety is an individuals
reaction to stress and their emotional state at a particular
time and this can fluctuate based on a specific event or situation. Trait Anxiety (Y-2), however, is related to an individuals personality trait and how they perceive stress.
The use of HRV serves as an objective measurement for
the study. It is an indirect measure of stress through
measuring changes to the autonomic nervous system and
the equilibrium of the sympathetic and parasympathetic
components of the autonomic nervous system [44]. One
understanding of the mechanisms of stress relates to the
neurological interaction of stimuli or stressors on the body
and the related interaction with the autonomic nervous
system [45], thereby causing abnormal autonomic and
cardiovascular responses [46]. Although it is established
there are correlations between stress and the autonomic
nervous system, the results are variable [34] and as such
HRV will only be included as a secondary outcome measure.
The inclusion of an active control group is to control for
the physical or exercise component within TC. This is to
ensure that the study does not take measurements solely
concerning the physical exercise aspects of TC but also
takes into account the nonexercise components that
contribute to the purported holistic benefits of practicing
TC. As such, the active control group is designed to match
TC in total hours required and also the total hours of supervised group interactions within both groups over the
period of 12 weeks. The dosage of intervention time prescribed has been compared to the 2008 report by Sannes
et al [47], and it exceeds the average hours reported in past
TC studies. Although the study is not powered to establish a
difference between the TC group and exercise group
number of participants to determine statistically whether
there may be a difference between these two groups, TC is
invariably less physically demanding on the body and does
not require specialized equipment present in a gymnasium.

The author affirms there are no conflicts of interest and the

author has no financial interest related to the material of
this manuscript.

Acknowledgments
S.Z., PhD student, has been awarded the Sydney Chinese
Lions Club Traditional Chinese Medicine Postgraduate
Scholarship, funded by the Sydney Chinese Lions Club Inc.
(SPIRIT item 4)

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