Trial Outcomes & Findings for Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults (NCT NCT01624168)

NCT ID: NCT01624168

Last Updated: 2016-01-08

Results Overview

Retained subjects are those who are willing to return for complete assessments

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

10 weeks

Results posted on

2016-01-08

Participant Flow

Participant milestones

Participant milestones
Measure
Anxiety Management Education
Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention
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
Enhanced Tai Chi Instruction
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 Study
STARTED
19
28
28
Overall Study
COMPLETED
15
16
22
Overall Study
NOT COMPLETED
4
12
6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Anxiety Management Education
n=19 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention
n=28 Participants
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
Enhanced Tai Chi Instruction
n=28 Participants
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
n=75 Participants
Total of all reporting groups
Age, Continuous
22.42 years
STANDARD_DEVIATION 5.47 • n=5 Participants
21.21 years
STANDARD_DEVIATION 3.04 • n=7 Participants
20.18 years
STANDARD_DEVIATION 1.16 • n=5 Participants
21.13 years
STANDARD_DEVIATION 3.5 • n=4 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
18 Participants
n=7 Participants
19 Participants
n=5 Participants
51 Participants
n=4 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
10 Participants
n=7 Participants
9 Participants
n=5 Participants
24 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 10 weeks

Retained subjects are those who are willing to return for complete assessments

Outcome measures

Outcome measures
Measure
Anxiety Management Education
n=19 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention
n=28 Participants
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
Enhanced Tai Chi Instruction
n=28 Participants
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
Retention of Randomized Subjects During Intervention
Retained
17 participants
22 participants
25 participants
Retention of Randomized Subjects During Intervention
Not retained
2 participants
6 participants
3 participants

PRIMARY outcome

Timeframe: 2 months

Subjects retained for follow-up are those willing to respond to follow-up assessments

Outcome measures

Outcome measures
Measure
Anxiety Management Education
n=19 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention
n=28 Participants
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
Enhanced Tai Chi Instruction
n=28 Participants
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
Retention of Randomized Subjects for Follow-up
Retained for follow-up
15 participants
16 participants
22 participants
Retention of Randomized Subjects for Follow-up
Lost to follow-up
4 participants
12 participants
6 participants

PRIMARY outcome

Timeframe: 10 weeks

Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention

Outcome measures

Outcome measures
Measure
Anxiety Management Education
n=19 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention
n=28 Participants
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
Enhanced Tai Chi Instruction
n=28 Participants
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
Adherence to Out-of-class Practice
Adherent to out-of-class practice
NA participants
Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.
13 participants
20 participants
Adherence to Out-of-class Practice
Not adherent to out-of-class practice
NA participants
Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.
15 participants
8 participants

PRIMARY outcome

Timeframe: 2 months

Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.

Outcome measures

Outcome measures
Measure
Anxiety Management Education
n=19 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention
n=28 Participants
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
Enhanced Tai Chi Instruction
n=28 Participants
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
Adherence to Practice After the Intervention
Not adherent to practice after the intervention
NA participants
Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.
24 participants
15 participants
Adherence to Practice After the Intervention
Adherent to practice after the intervention
NA participants
Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.
4 participants
13 participants

SECONDARY outcome

Timeframe: change from baseline to 4 weeks, 10 weeks, 2 month follow-up

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.

Outcome measures

Outcome measures
Measure
Anxiety Management Education
n=17 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention
n=22 Participants
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
Enhanced Tai Chi Instruction
n=25 Participants
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
Change From Baseline in State Anxiety Scores
Change from Baseline to 4 weeks
-1.93 units on a scale
Standard Error 2.06
-2.70 units on a scale
Standard Error 1.79
-3.17 units on a scale
Standard Error 1.68
Change From Baseline in State Anxiety Scores
Change from Baseline to 10 weeks
-1.43 units on a scale
Standard Error 2.09
-4.36 units on a scale
Standard Error 1.89
-3.04 units on a scale
Standard Error 1.73
Change From Baseline in State Anxiety Scores
Change from Baseline to 2 Month Follow-up
-1.90 units on a scale
Standard Error 2.15
-5.08 units on a scale
Standard Error 2.03
-3.58 units on a scale
Standard Error 1.78

SECONDARY outcome

Timeframe: baseline, 4 weeks, 10 weeks, 2 month follow-up

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.

Outcome measures

Outcome measures
Measure
Anxiety Management Education
n=17 Participants
Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention
n=22 Participants
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
Enhanced Tai Chi Instruction
n=25 Participants
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
Change From Baseline in Pittsburgh Sleep Quality Index Scores
Change from Baseline to 4 weeks
-1.06 units on a scale
Standard Error .45
-1.40 units on a scale
Standard Error .39
-1.32 units on a scale
Standard Error .36
Change From Baseline in Pittsburgh Sleep Quality Index Scores
Change from Baseline to 10 weeks
-1.71 units on a scale
Standard Error .46
-2.98 units on a scale
Standard Error .41
-2.03 units on a scale
Standard Error .38
Change From Baseline in Pittsburgh Sleep Quality Index Scores
Change from Baseline to 2 month follow-up
-1.82 units on a scale
Standard Error .47
-3.60 units on a scale
Standard Error .45
-3.05 units on a scale
Standard Error .38

Adverse Events

Anxiety Management Education

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

10 Week Tai Chi Intervention

Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths

Enhanced Tai Chi Instruction

Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Anxiety Management Education
n=19 participants at risk
Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention
n=28 participants at risk
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
Enhanced Tai Chi Instruction
n=28 participants at risk
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
Psychiatric disorders
overdose suicide attempt
0.00%
0/19 • 6 months
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.
0.00%
0/28 • 6 months
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.
3.6%
1/28 • 6 months
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.
Musculoskeletal and connective tissue disorders
Fell on ice, broke ankle
0.00%
0/19 • 6 months
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.
3.6%
1/28 • 6 months
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.
0.00%
0/28 • 6 months
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.

Other adverse events

Other adverse events
Measure
Anxiety Management Education
n=19 participants at risk
Anxiety Management Education: written materials on management of anxiety for self-study
10 Week Tai Chi Intervention
n=28 participants at risk
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
Enhanced Tai Chi Instruction
n=28 participants at risk
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
Psychiatric disorders
Anger
5.3%
1/19 • 6 months
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.
0.00%
0/28 • 6 months
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.
0.00%
0/28 • 6 months
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.
Psychiatric disorders
Anxiety
15.8%
3/19 • 6 months
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.
3.6%
1/28 • 6 months
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.
10.7%
3/28 • 6 months
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.
Psychiatric disorders
Anxiety with Depression
10.5%
2/19 • 6 months
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.
3.6%
1/28 • 6 months
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.
3.6%
1/28 • 6 months
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.
Respiratory, thoracic and mediastinal disorders
Cold
5.3%
1/19 • 6 months
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.
17.9%
5/28 • 6 months
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.
17.9%
5/28 • 6 months
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.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
5.3%
1/19 • 6 months
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.
0.00%
0/28 • 6 months
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.
7.1%
2/28 • 6 months
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.
Social circumstances
Family Stress
10.5%
2/19 • 6 months
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.
0.00%
0/28 • 6 months
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.
3.6%
1/28 • 6 months
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.
Psychiatric disorders
Feeling Blue
0.00%
0/19 • 6 months
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.
7.1%
2/28 • 6 months
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.
14.3%
4/28 • 6 months
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.
General disorders
Feeling sick
0.00%
0/19 • 6 months
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.
7.1%
2/28 • 6 months
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.
10.7%
3/28 • 6 months
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.
Musculoskeletal and connective tissue disorders
Knee pain
5.3%
1/19 • 6 months
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.
0.00%
0/28 • 6 months
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.
3.6%
1/28 • 6 months
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.
Nervous system disorders
Poor sleep
5.3%
1/19 • 6 months
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.
0.00%
0/28 • 6 months
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.
3.6%
1/28 • 6 months
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.
Psychiatric disorders
Stress
5.3%
1/19 • 6 months
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.
3.6%
1/28 • 6 months
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.
10.7%
3/28 • 6 months
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.
Gastrointestinal disorders
Vomiting
15.8%
3/19 • 6 months
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.
0.00%
0/28 • 6 months
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.
3.6%
1/28 • 6 months
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.
Psychiatric disorders
Worry
10.5%
2/19 • 6 months
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.
0.00%
0/28 • 6 months
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.
0.00%
0/28 • 6 months
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.

Additional Information

Dr. Karen Caldwell, Professor

Appalachian State University

Phone: 828-262-6045

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place