NCT01122706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

7 months

First QC Date

April 12, 2010

Last Update Submit

July 25, 2011

Conditions

Keywords

tai jipsychosocial stressprimary preventionTrier Social Stress Testsalivary cortisolsalivary alpha amylaseheart rate variabilitystress management

Outcome Measures

Primary Outcomes (1)

  • 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.

    durring the Trier Social Stress Test

Secondary Outcomes (8)

  • salivary alpha amylase reactivity to psychosocial stress

    8 times during the Trier Social Stress Test (which lasts 2h)

  • heart rate

    continuously during the Trier Social Stress Test (which lasts 2h)

  • heart rate variability

    continuously during the Trier Social Stress Test (which lasts 2h)

  • perceived stress

    before, after the Taiji training and 2 months follow up

  • self-efficacy-expectancy

    before, after the Taiji training and 2 months follow up

  • +3 more secondary outcomes

Study Arms (2)

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).

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).

Interventions

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.

Also known as: Taiji, Tai Chi, Tai Chi Chuan, Taijiquan
Taiji

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern, Institute of Complementary Medicine KIKOM

Bern, 3010, Switzerland

Location

Related Publications (6)

  • 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.

    PMID: 19635269BACKGROUND
  • Raison 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.

    PMID: 12944327BACKGROUND
  • Klein 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.

    PMID: 15314540BACKGROUND
  • Esch 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.

    PMID: 17968296BACKGROUND
  • Dickerson 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.

    PMID: 15122924BACKGROUND
  • Nedeljkovic 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.

MeSH Terms

Interventions

Tai Ji

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Marko Nedeljkovic, MSc

    Institute of Complementary Medicine KIKOM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2010

First Posted

May 13, 2010

Study Start

July 1, 2010

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations