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Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults

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ClinicalTrials.gov Identifier: NCT01624168
Recruitment Status : Completed
First Posted : June 20, 2012
Results First Posted : September 29, 2015
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Karen Caldwell, Appalachian State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anxiety
Interventions Behavioral: Anxiety Management Education
Behavioral: 10 week tai chi intervention
Behavioral: Enhanced tai chi instruction
Enrollment 75

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Hide Arm/Group Description Anxiety Management Education: written materials on management of anxiety for self-study

10 week course in Evidence Based Tai Chi meeting 2 times per week

10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Period Title: Overall Study
Started 19 28 28
Completed 15 16 22
Not Completed 4 12 6
Arm/Group Title Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction Total
Hide Arm/Group Description Anxiety Management Education: written materials on management of anxiety for self-study

10 week course in Evidence Based Tai Chi meeting 2 times per week

10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Total of all reporting groups
Overall Number of Baseline Participants 19 28 28 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 28 participants 28 participants 75 participants
22.42  (5.47) 21.21  (3.04) 20.18  (1.16) 21.13  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 28 participants 28 participants 75 participants
Female
14
  73.7%
18
  64.3%
19
  67.9%
51
  68.0%
Male
5
  26.3%
10
  35.7%
9
  32.1%
24
  32.0%
1.Primary Outcome
Title Retention of Randomized Subjects During Intervention
Hide Description Retained subjects are those who are willing to return for complete assessments
Time Frame 10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Hide Arm/Group Description:
Anxiety Management Education: written materials on management of anxiety for self-study

10 week course in Evidence Based Tai Chi meeting 2 times per week

10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Overall Number of Participants Analyzed 19 28 28
Measure Type: Number
Unit of Measure: participants
Retained 17 22 25
Not retained 2 6 3
2.Primary Outcome
Title Retention of Randomized Subjects for Follow-up
Hide Description Subjects retained for follow-up are those willing to respond to follow-up assessments
Time Frame 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Hide Arm/Group Description:
Anxiety Management Education: written materials on management of anxiety for self-study

10 week course in Evidence Based Tai Chi meeting 2 times per week

10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Overall Number of Participants Analyzed 19 28 28
Measure Type: Number
Unit of Measure: participants
Retained for follow-up 15 16 22
Lost to follow-up 4 12 6
3.Primary Outcome
Title Adherence to Out-of-class Practice
Hide Description Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention
Time Frame 10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Hide Arm/Group Description:
Anxiety Management Education: written materials on management of anxiety for self-study

10 week course in Evidence Based Tai Chi meeting 2 times per week

10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Overall Number of Participants Analyzed 19 28 28
Measure Type: Number
Unit of Measure: participants
Adherent to out-of-class practice NA [1]  13 20
Not adherent to out-of-class practice NA [1]  15 8
[1]
Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.
4.Primary Outcome
Title Adherence to Practice After the Intervention
Hide Description Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.
Time Frame 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Hide Arm/Group Description:
Anxiety Management Education: written materials on management of anxiety for self-study

10 week course in Evidence Based Tai Chi meeting 2 times per week

10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Overall Number of Participants Analyzed 19 28 28
Measure Type: Number
Unit of Measure: participants
Adherent to practice after the intervention NA [1]  4 13
Not adherent to practice after the intervention NA [1]  24 15
[1]
Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.
5.Secondary Outcome
Title Change From Baseline in State Anxiety Scores
Hide Description Anxiety was measured by the State Trait Anxiety Inventory - State Scale. Lower scores on this scale reflect better outcomes. Scores can range from 20 to 80.
Time Frame change from baseline to 4 weeks, 10 weeks, 2 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Hide Arm/Group Description:
Anxiety Management Education: written materials on management of anxiety for self-study

10 week course in Evidence Based Tai Chi meeting 2 times per week

10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Overall Number of Participants Analyzed 17 22 25
Mean (Standard Error)
Unit of Measure: units on a scale
Change from Baseline to 4 weeks -1.93  (2.06) -2.70  (1.79) -3.17  (1.68)
Change from Baseline to 10 weeks -1.43  (2.09) -4.36  (1.89) -3.04  (1.73)
Change from Baseline to 2 Month Follow-up -1.90  (2.15) -5.08  (2.03) -3.58  (1.78)
6.Secondary Outcome
Title Change From Baseline in Pittsburgh Sleep Quality Index Scores
Hide Description Sleep quality was measured by the Pittsburgh Sleep Quality Index Total Score. Lower scores on this scale reflect better outcomes. Scores can range from 0 to 21.
Time Frame baseline, 4 weeks, 10 weeks, 2 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Hide Arm/Group Description:
Anxiety Management Education: written materials on management of anxiety for self-study

10 week course in Evidence Based Tai Chi meeting 2 times per week

10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Overall Number of Participants Analyzed 17 22 25
Mean (Standard Error)
Unit of Measure: units on a scale
Change from Baseline to 4 weeks -1.06  (.45) -1.40  (.39) -1.32  (.36)
Change from Baseline to 10 weeks -1.71  (.46) -2.98  (.41) -2.03  (.38)
Change from Baseline to 2 month follow-up -1.82  (.47) -3.60  (.45) -3.05  (.38)
Time Frame 6 months
Adverse Event Reporting Description Participants were asked to complete weekly reports of mood using the Generalized Anxiety Disorder-7 scale and the Patient Health Questionnaire - 2. Participants also were asked about adverse events at 4-week and 10-week laboratory visits.
 
Arm/Group Title Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Hide Arm/Group Description Anxiety Management Education: written materials on management of anxiety for self-study

10 week course in Evidence Based Tai Chi meeting 2 times per week

10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week

10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice

All-Cause Mortality
Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   1/28 (3.57%)   1/28 (3.57%) 
Musculoskeletal and connective tissue disorders       
Fell on ice, broke ankle  1  0/19 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Psychiatric disorders       
overdose suicide attempt  1  0/19 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Anxiety Management Education 10 Week Tai Chi Intervention Enhanced Tai Chi Instruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/19 (47.37%)   9/28 (32.14%)   12/28 (42.86%) 
Gastrointestinal disorders       
Vomiting  1  3/19 (15.79%)  0/28 (0.00%)  1/28 (3.57%) 
General disorders       
Feeling sick  1  0/19 (0.00%)  2/28 (7.14%)  3/28 (10.71%) 
Musculoskeletal and connective tissue disorders       
Knee pain  1  1/19 (5.26%)  0/28 (0.00%)  1/28 (3.57%) 
Nervous system disorders       
Poor sleep  1  1/19 (5.26%)  0/28 (0.00%)  1/28 (3.57%) 
Psychiatric disorders       
Anger  1  1/19 (5.26%)  0/28 (0.00%)  0/28 (0.00%) 
Anxiety  1  3/19 (15.79%)  1/28 (3.57%)  3/28 (10.71%) 
Anxiety with Depression  1  2/19 (10.53%)  1/28 (3.57%)  1/28 (3.57%) 
Feeling Blue  1  0/19 (0.00%)  2/28 (7.14%)  4/28 (14.29%) 
Stress  1  1/19 (5.26%)  1/28 (3.57%)  3/28 (10.71%) 
Worry  1  2/19 (10.53%)  0/28 (0.00%)  0/28 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cold  1  1/19 (5.26%)  5/28 (17.86%)  5/28 (17.86%) 
Nasal congestion  1  1/19 (5.26%)  0/28 (0.00%)  2/28 (7.14%) 
Social circumstances       
Family Stress  1  2/19 (10.53%)  0/28 (0.00%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
None of the reported Serious Adverse Events or Adverse Events were determined to be a result of participation in the intervention.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Karen Caldwell, Professor
Organization: Appalachian State University
Phone: 828-262-6045