Primary PreventionNCT01122706
Efficacy of Taiji Training as a Program for Stress Prevention
A study testing Taiji training in people with Primary Prevention and Stress, run by University of Bern at 1 site in Switzerland.
Trial summary
Background: Excessive exposure to psychosocial stress can be a potent trigger for somatic diseases and psychological disorders, a cause for missing work, and eventually lead to high economic loss. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention, Stress, Tai ji
- What is being tested?
- Taiji training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ready to participate in the Taiji-intervention group as well as in the Waiting list control group
- mentally healthy
- physically healthy
- fluent in German (written and spoken)
Who cannot join
- previous practical experience with Taiji-exercises
- previous practical experience with the Trier Social Stress Test
- being absent for more than one week between Sept. 6th and Nov. 25th 2010
- daily alcohol consumption more than two alcoholic drinks
- daily tobacco consumption more than five cigarettes per day
- any kind of drug consumption
- pregnancy
- intake of hormonal compounds i.e. birth control pill and hormon replacement therapy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Bern, Institute of Complementary Medicine KIKOM
Bern, 3010
About this study
Official title: Efficacy of Taiji Training as a Program for Stress Prevention - a Randomized, Waiting List Controlled Longitudinal Study With Healthy Subjects
Background: Excessive exposure to psychosocial stress can be a potent trigger for somatic diseases and psychological disorders, a cause for missing work, and eventually lead to high economic loss. Therefore, for health and economic reasons the assessment of effectiveness of stress preventive interventions is of high relevance. According to several clinical studies, Taiji, a Chinese form of mindful and gentle movements, can significantly reduce symptoms of somatic diseases and psychological disorders. Some recently conducted Taiji-studies with healthy subjects indicate a stress protective effect. However, the stress protective impact of Taiji regarding psychosocial stress has not yet been examined.
Objective: To investigate the efficacy of a 12 week Taiji training as a stress prevention program by measuring psychosocial stress reactivity in a laboratory setting, as well as the subjective perception of stress and coping-resources in daily life of 70 healthy volunteers.
Hypothesis: Healthy subjects attending a 12 week Taiji course (frequency: twice a week for 1h) will show significantly reduced psychobiological reactivity, decreased stress perception and increased coping-resources on a standardized psychosocial stress test compared with healthy subject of the waiting list.
Read the detailed description
Background:
Excessive exposure to psychosocial stress can be a potent trigger for somatic diseases and psychological disorders, a cause for missing work, and eventually lead to high economic loss. Therefore, for health and economic reasons the assessment of effectiveness of stress preventive interventions is of high relevance. According to several clinical studies, Taiji, a Chinese form of mindful and gentle movements, can significantly reduce symptoms of somatic diseases and psychological disorders. Some recent Taiji-studies with healthy subjects indicate a stress protective effect. However, since these findings mainly focus on effects during or immediately after a Taiji training session, their study designs and outcome measures are not comparable with existing stress prevention efficacy studies and their sample sizes are generally too small, the present available results remain inconclusive. Also, the impact of a Taiji training on psychosocial stress has not been assessed so far.
Objective:
The objective of this study is to assess the efficacy of a 12 week Taiji training as a stress prevention program by measuring psychosocial stress reactivity in a laboratory setting, subjective perception of stress and coping-resources of 70 healthy subjects in daily life.
Methods:
The Trier Social Stress Test (TSST) will be used to measure the psychobiological stress reactivity. Salivary cortisol, alpha amylase, heart rate and heart rate variability will be measured in each subject to asses stress reactivity, Also, the primary appraisal secondary appraisal (PASA) questionnaire and the multidimensional mood questionnaire (MDBF) will be used to assess psychological stress reactivity, and a visual analogue scale (VAS) to measure perceived stressfulness.
Additionally to the TSST setting, pre-, post-intervention and 2 months follow up measurements will be taken. The following tools will be used: Perceived Stress Scale (PSS), Stress Reactivity Scale (SRS)(to assess perceived stress), and self-efficacy-expectancy questionnaire (SWE), questionnaire for measuring wellbeing (FEW-16), Freiburg mindfulness inventory (FMI) and self compassion scale (SCS) (to assess perceived coping resources).
- Conditions
- Primary Prevention, Stress, Tai ji, Adult
- Being tested
- Taiji training
- Keywords
- tai ji, psychosocial stress, primary prevention, Trier Social Stress Test, salivary cortisol, salivary alpha amylase, heart rate variability, stress management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taiji trainingOther
Also called Taiji, Tai Chi, Tai Chi Chuan, Taijiquan
Taiji training during 12 weeks (twice a week for 1 hour) (Sept. 6th till Nov. 25th 2010). The first 18 sequences of a series of 37 movements of the short form Yang style Taiji will be taught. The focus will be on memorizing the series of movements, developing a regular training routine and working on body alignment and flow of the movements.
| Study group | Role | What they receive |
|---|---|---|
| Taiji | Experimental | 35 healthy participants will regularly during 12 weeks attend Taiji training classes twice a week for one hour. (Sept. 6th till Nov. 25th 2010). Receives: Other: Taiji training |
| waiting list control group | No intervention | 35 healthy participants are not allowed to attend any Taiji training during the intervention period (Sept. 6th till Nov. 25th 2010). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) with respect to increase of salivary cortisol titer
saliva samples will be taken 8 times during the Trier Social Stresstest. Salivary cortisol reactivity in response to this psychosocial stress test will be calculated by aggregating cortisol data of all 8 saliva samples in an AUC value with respect to increase.
Measured: durring the Trier Social Stress Test
Secondary outcomes (8)
salivary alpha amylase reactivity to psychosocial stress
Measured: 8 times during the Trier Social Stress Test (which lasts 2h)
heart rate
Measured: continuously during the Trier Social Stress Test (which lasts 2h)
heart rate variability
Measured: continuously during the Trier Social Stress Test (which lasts 2h)
perceived stress
to be measured by using the percieved stress scale (PSS)
Measured: before, after the Taiji training and 2 months follow up
self-efficacy-expectancy
to be measured by using the self-efficacy-expectancy questionnaire (SWE)
Measured: before, after the Taiji training and 2 months follow up
wellbeing
to be measured by using the questionnaire for measuring wellbeing (FEW-16)
Measured: before, after the Taiji training and 2 months follow up
Mindfulness
to be measured by using the Freiburg mindfulness inventory (FMI)
Measured: before, after the Taiji training and 2 months follow up
Self Compassion
to be measured by using the self compassion scale (SCS)
Measured: before, after the Taiji training and 2 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Investigators
- Marko Nedeljkovic, MSc, Principal investigator, Institute of Complementary Medicine KIKOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122706
- Sponsor's protocol ID
- 058/10
- Status last verified
- Jul 2011
- First submitted
- 12 Apr 2010
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Figueredo VM. The time has come for physicians to take notice: the impact of psychosocial stressors on the heart. Am J Med. 2009 Aug;122(8):704-12. doi: 10.1016/j.amjmed.2009.05.001.
PubMed 19635269Raison CL, Miller AH. When not enough is too much: the role of insufficient glucocorticoid signaling in the pathophysiology of stress-related disorders. Am J Psychiatry. 2003 Sep;160(9):1554-65. doi: 10.1176/appi.ajp.160.9.1554.
PubMed 12944327Klein PJ, Adams WD. Comprehensive therapeutic benefits of Taiji: a critical review. Am J Phys Med Rehabil. 2004 Sep;83(9):735-45. doi: 10.1097/01.phm.0000137317.98890.74.
PubMed 15314540Esch T, Duckstein J, Welke J, Braun V. Mind/body techniques for physiological and psychological stress reduction: stress management via Tai Chi training - a pilot study. Med Sci Monit. 2007 Nov;13(11):CR488-497.
PubMed 17968296Dickerson SS, Kemeny ME. Acute stressors and cortisol responses: a theoretical integration and synthesis of laboratory research. Psychol Bull. 2004 May;130(3):355-91. doi: 10.1037/0033-2909.130.3.355.
PubMed 15122924Nedeljkovic M, Ausfeld-Hafter B, Streitberger K, Seiler R, Wirtz PH. Taiji practice attenuates psychobiological stress reactivity--a randomized controlled trial in healthy subjects. Psychoneuroendocrinology. 2012 Aug;37(8):1171-80. doi: 10.1016/j.psyneuen.2011.12.007. Epub 2012 Jan 4.
PubMed 22222120
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Taiji Training as a Program for Stress Prevention - a Randomized, Waiting List Controlled Longitudinal Study With Healthy Subjects
- ClinicalTrials.gov ID
- NCT01122706
- Acronym / sponsor ID
- 058/10
- Conditions
- Primary Prevention, Stress, Tai ji, Adult
- Keywords
- tai ji, psychosocial stress, primary prevention, Trier Social Stress Test, salivary cortisol, salivary alpha amylase, heart rate variability, stress management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Excessive exposure to psychosocial stress can be a potent trigger for somatic diseases and psychological disorders, a cause for missing work, and eventually lead to high economic loss. Therefore, for health and economic reasons the assessment of effectiveness of stress preventive interventions is of high relevance. According to several clinical studies, Taiji, a Chinese form of mindful and gentle movements, can significantly reduce symptoms of somatic diseases and psychological disorders. Some recently conducted Taiji-studies with healthy subjects indicate a stress protective effect. However, the stress protective impact of Taiji regarding psychosocial stress has not yet been examined.
Objective: To investigate the efficacy of a 12 week Taiji training as a stress prevention program by measuring psychosocial stress reactivity in a laboratory setting, as well as the subjective perception of stress and coping-resources in daily life of 70 healthy volunteers.
Hypothesis: Healthy subjects attending a 12 week Taiji course (frequency: twice a week for 1h) will show significantly reduced psychobiological reactivity, decreased stress perception and increased coping-resources on a standardized psychosocial stress test compared with healthy subject of the waiting list.
Detailed description
Background:
Excessive exposure to psychosocial stress can be a potent trigger for somatic diseases and psychological disorders, a cause for missing work, and eventually lead to high economic loss. Therefore, for health and economic reasons the assessment of effectiveness of stress preventive interventions is of high relevance. According to several clinical studies, Taiji, a Chinese form of mindful and gentle movements, can significantly reduce symptoms of somatic diseases and psychological disorders. Some recent Taiji-studies with healthy subjects indicate a stress protective effect. However, since these findings mainly focus on effects during or immediately after a Taiji training session, their study designs and outcome measures are not comparable with existing stress prevention efficacy studies and their sample sizes are generally too small, the present available results remain inconclusive. Also, the impact of a Taiji training on psychosocial stress has not been assessed so far.
Objective:
The objective of this study is to assess the efficacy of a 12 week Taiji training as a stress prevention program by measuring psychosocial stress reactivity in a laboratory setting, subjective perception of stress and coping-resources of 70 healthy subjects in daily life.
Methods:
The Trier Social Stress Test (TSST) will be used to measure the psychobiological stress reactivity. Salivary cortisol, alpha amylase, heart rate and heart rate variability will be measured in each subject to asses stress reactivity, Also, the primary appraisal secondary appraisal (PASA) questionnaire and the multidimensional mood questionnaire (MDBF) will be used to assess psychological stress reactivity, and a visual analogue scale (VAS) to measure perceived stressfulness.
Additionally to the TSST setting, pre-, post-intervention and 2 months follow up measurements will be taken. The following tools will be used: Perceived Stress Scale (PSS), Stress Reactivity Scale (SRS)(to assess perceived stress), and self-efficacy-expectancy questionnaire (SWE), questionnaire for measuring wellbeing (FEW-16), Freiburg mindfulness inventory (FMI) and self compassion scale (SCS) (to assess perceived coping resources).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taiji | Experimental | Other: Taiji training35 healthy participants will regularly during 12 weeks attend Taiji training classes twice a week for one hour. (Sept. 6th till Nov. 25th 2010). |
| waiting list control group | No intervention | –35 healthy participants are not allowed to attend any Taiji training during the intervention period (Sept. 6th till Nov. 25th 2010). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ready to participate in the Taiji-intervention group as well as in the Waiting list control group
- mentally healthy
- physically healthy
- fluent in German (written and spoken)
Key exclusion criteria (8 listed)
- previous practical experience with Taiji-exercises
- previous practical experience with the Trier Social Stress Test
- being absent for more than one week between Sept. 6th and Nov. 25th 2010
- daily alcohol consumption more than two alcoholic drinks
- daily tobacco consumption more than five cigarettes per day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taiji trainingAlso: Taiji, Tai Chi, Tai Chi Chuan, TaijiquanTaiji training during 12 weeks (twice a week for 1 hour) (Sept. 6th till Nov. 25th 2010). The first 18 sequences of a series of 37 movements of the short form Yang style Taiji will be taught. The focus will be on memorizing the series of movements, developing a regular training routine and working on body alignment and flow of the movements. | Other | Taiji |
Primary outcome
Area under the curve (AUC) with respect to increase of salivary cortisol titer
Time frame: durring the Trier Social Stress Test
saliva samples will be taken 8 times during the Trier Social Stresstest. Salivary cortisol reactivity in response to this psychosocial stress test will be calculated by aggregating cortisol data of all 8 saliva samples in an AUC value with respect to increase.
8 secondary outcomes
salivary alpha amylase reactivity to psychosocial stress
Time frame: 8 times during the Trier Social Stress Test (which lasts 2h)
heart rate
Time frame: continuously during the Trier Social Stress Test (which lasts 2h)
heart rate variability
Time frame: continuously during the Trier Social Stress Test (which lasts 2h)
perceived stress
Time frame: before, after the Taiji training and 2 months follow up
self-efficacy-expectancy
Time frame: before, after the Taiji training and 2 months follow up
wellbeing
Time frame: before, after the Taiji training and 2 months follow up
Mindfulness
Time frame: before, after the Taiji training and 2 months follow up
Self Compassion
Time frame: before, after the Taiji training and 2 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
- Background: PubMed 19635269Figueredo VM. The time has come for physicians to take notice: the impact of psychosocial stressors on the heart. Am J Med. 2009 Aug;122(8):704-12. doi: 10.1016/j.amjmed.2009.05.001.
- Background: PubMed 12944327Raison CL, Miller AH. When not enough is too much: the role of insufficient glucocorticoid signaling in the pathophysiology of stress-related disorders. Am J Psychiatry. 2003 Sep;160(9):1554-65. doi: 10.1176/appi.ajp.160.9.1554.
- Background: PubMed 15314540Klein PJ, Adams WD. Comprehensive therapeutic benefits of Taiji: a critical review. Am J Phys Med Rehabil. 2004 Sep;83(9):735-45. doi: 10.1097/01.phm.0000137317.98890.74.
- Background: PubMed 17968296Esch T, Duckstein J, Welke J, Braun V. Mind/body techniques for physiological and psychological stress reduction: stress management via Tai Chi training - a pilot study. Med Sci Monit. 2007 Nov;13(11):CR488-497.
- Background: PubMed 15122924Dickerson SS, Kemeny ME. Acute stressors and cortisol responses: a theoretical integration and synthesis of laboratory research. Psychol Bull. 2004 May;130(3):355-91. doi: 10.1037/0033-2909.130.3.355.
- Derived from this study: PubMed 22222120Nedeljkovic M, Ausfeld-Hafter B, Streitberger K, Seiler R, Wirtz PH. Taiji practice attenuates psychobiological stress reactivity--a randomized controlled trial in healthy subjects. Psychoneuroendocrinology. 2012 Aug;37(8):1171-80. doi: 10.1016/j.psyneuen.2011.12.007. Epub 2012 Jan 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Nedeljkovic, MSc principal investigator
Institute of Complementary Medicine KIKOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taiji training in people with Primary Prevention and Stress, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) with respect to increase of salivary cortisol titer (time frame: durring the Trier Social Stress Test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01122706, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.