Efficacy of Taiji Training as a Program for Stress Prevention

This study has been completed.
Sponsor:
Collaborator:
Swiss Federal Institute of Technology
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT01122706
First received: April 12, 2010
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Primary Prevention
Stress
Tai ji
Adult
Other: Taiji training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Taiji Training as a Program for Stress Prevention - a Randomized, Waiting List Controlled Longitudinal Study With Healthy Subjects

Further study details as provided by University of Bern:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • salivary alpha amylase reactivity to psychosocial stress [ Time Frame: 8 times during the Trier Social Stress Test (which lasts 2h) ] [ Designated as safety issue: No ]
  • heart rate [ Time Frame: continuously during the Trier Social Stress Test (which lasts 2h) ] [ Designated as safety issue: No ]
  • heart rate variability [ Time Frame: continuously during the Trier Social Stress Test (which lasts 2h) ] [ Designated as safety issue: No ]
  • perceived stress [ Time Frame: before, after the Taiji training and 2 months follow up ] [ Designated as safety issue: No ]
    to be measured by using the percieved stress scale (PSS)

  • self-efficacy-expectancy [ Time Frame: before, after the Taiji training and 2 months follow up ] [ Designated as safety issue: No ]
    to be measured by using the self-efficacy-expectancy questionnaire (SWE)

  • wellbeing [ Time Frame: before, after the Taiji training and 2 months follow up ] [ Designated as safety issue: No ]
    to be measured by using the questionnaire for measuring wellbeing (FEW-16)

  • Mindfulness [ Time Frame: before, after the Taiji training and 2 months follow up ] [ Designated as safety issue: No ]
    to be measured by using the Freiburg mindfulness inventory (FMI)

  • Self Compassion [ Time Frame: before, after the Taiji training and 2 months follow up ] [ Designated as safety issue: No ]
    to be measured by using the self compassion scale (SCS)


Enrollment: 70
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Taiji
35 healthy participants will regularly during 12 weeks attend Taiji training classes twice a week for one hour. (Sept. 6th till Nov. 25th 2010).
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.
Other Names:
  • Taiji
  • Tai Chi
  • Tai Chi Chuan
  • Taijiquan
No Intervention: waiting list control group
35 healthy participants are not allowed to attend any Taiji training during the intervention period (Sept. 6th till Nov. 25th 2010).

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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122706

Locations
Switzerland
University of Bern, Institute of Complementary Medicine KIKOM
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
Swiss Federal Institute of Technology
Investigators
Principal Investigator: Marko Nedeljkovic, MSc Institute of Complementary Medicine KIKOM
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nedeljkovic Marko / MSc, University of Bern, Institute of Complementary Medicine KIKOM
ClinicalTrials.gov Identifier: NCT01122706     History of Changes
Other Study ID Numbers: 058/10
Study First Received: April 12, 2010
Last Updated: July 25, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Bern:
tai ji
psychosocial stress
primary prevention
Trier Social Stress Test
salivary cortisol
salivary alpha amylase
heart rate variability
stress management

ClinicalTrials.gov processed this record on August 28, 2014