Efficacy of Taiji Training as a Program for Stress Prevention
| Tracking Information | |||||
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| First Received Date ICMJE | April 12, 2010 | ||||
| Last Updated Date | July 25, 2011 | ||||
| Start Date ICMJE | July 2010 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Area under the curve (AUC) with respect to increase of salivary cortisol titer [ Time Frame: durring the Trier Social Stress Test ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01122706 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Taiji Training as a Program for Stress Prevention | ||||
| Official Title ICMJE | Efficacy of Taiji Training as a Program for Stress Prevention - a Randomized, Waiting List Controlled Longitudinal Study With Healthy Subjects | ||||
| Brief 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. 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. |
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| 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Taiji training
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.
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 70 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01122706 | ||||
| Other Study ID Numbers ICMJE | 058/10 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nedeljkovic Marko / MSc, University of Bern, Institute of Complementary Medicine KIKOM | ||||
| Study Sponsor ICMJE | University of Bern | ||||
| Collaborators ICMJE | Swiss Federal Institute of Technology | ||||
| Investigators ICMJE |
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| Information Provided By | University of Bern | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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