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Tai Chi Mind-Body Therapy for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00362453
Recruitment Status : Completed
First Posted : August 10, 2006
Results First Posted : February 8, 2010
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Tufts Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Knee Osteoarthritis
Intervention Behavioral: Tai Chi versus Attention Control
Enrollment 40
Recruitment Details During the 5-month recruitment period, we screened 366 patients from the Greater Boston area using telephone interviews. 62 potential patients visited the Clinical and Translational Research Center at Tufts Medical Center for further eligibility screening; 40 were eligible after baseline evaluation and randomized to Tai Chi or attention control.
Pre-assignment Details We excluded individuals with: prior Tai Chi training or similar alternative medicine types like Qi Gong or yoga; serious medical conditions; intra-articular steroid injections in the last 3 months, reconstructive surgery on the affected knee, and intra-articular hyaluronate injections in the previous 6 months; failed the Mini-Mental examination.
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks. 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Period Title: Overall Study
Started 20 20
Completed 20 [1] 20 [1]
Not Completed 0 0
[1]
No patient withdrew from the study (20/20 participants completed follow-ups at 12, 24 and 48 weeks).
Arm/Group Title Tai Chi Attention Control Total
Hide Arm/Group Description 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks. 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
63  (8.1) 68  (7.0) 65  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
16
  80.0%
14
  70.0%
30
  75.0%
Male
4
  20.0%
6
  30.0%
10
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks
Hide Description WOMAC scale range: 0 millimeters (no pain) to 500 millimeters (severe pain), ordinal. Change: score at 12 weeks minus score at baseline. Negative numbers reported here indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)
Time Frame between baseline and 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
We analyzed the data on an intent-to-treat basis.
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: mm
-157.25
(-203.11 to -111.39)
-38.45
(-84.31 to 7.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -118.80
Confidence Interval (2-Sided) 95%
-183.66 to -53.94
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks.
Hide Description The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The function subscale had a score range 0-1700mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)
Time Frame from baseline to 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: mm
12 Week
-506.75
(-640.66 to -372.84)
-182.15
(-316.06 to -48.24)
24 Week
-440.50
(-574.41 to -306.59)
-257.30
(-391.21 to -123.39)
48 Week
-405.85
(-539.76 to -271.94)
-300.55
(-434.46 to -166.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -324.60
Confidence Interval (2-Sided) 95%
-513.98 to -135.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -183.20
Confidence Interval (2-Sided) 95%
-372.58 to 6.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -105.30
Confidence Interval (2-Sided) 95%
-294.68 to 84.08
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks.
Hide Description The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The stiffness subscale has a score range 0-200mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)
Time Frame baseline to 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: mm
12 Week
-73.05
(-94.36 to -51.74)
-50.15
(-71.46 to -28.84)
24 Week
-65.00
(-86.31 to -43.69)
-50.20
(-71.51 to -28.89)
48 Week
-64.15
(-85.46 to -42.84)
-60.50
(-81.81 to -39.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.90
Confidence Interval (2-Sided) 95%
-53.04 to 7.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.80
Confidence Interval (2-Sided) 95%
-44.94 to 15.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.65
Confidence Interval (2-Sided) 95%
-33.79 to 26.49
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks.
Hide Description The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The WOMAC was administered to the participants at baseline, 12, 24 and 48 weeks. The pain subscale score range was 0-500mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)
Time Frame baseline to 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The 12-Week WOMAC scores are listed under Primary Outcome. The 24-Week and 48-Week scores are listed as Secondary Outcomes.
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: mm
24 Weeks
-131.55
(-177.41 to -85.69)
-64.60
(-110.46 to -18.74)
48 Weeks
-115.35
(-161.21 to -69.49)
-69.20
(-115.06 to -23.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -66.95
Confidence Interval (2-Sided) 95%
-131.81 to -2.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -46.15
Confidence Interval (2-Sided) 95%
-111.01 to 18.71
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS)
Hide Description Participants completed a self-reported knee-specific global pain VAS with scores ranging from 0 to 10 centimeters (cm); 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)
Time Frame baseline to 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: cm
12 Week
-2.98
(-4.16 to -1.80)
-0.83
(-2.00 to 0.35)
24 Week
-2.36
(-3.53 to -1.18)
-1.71
(-2.89 to -0.53)
48 Week
-1.65
(-2.83 to -0.48)
-1.70
(-2.87 to -0.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.15
Confidence Interval (2-Sided) 95%
-3.82 to -0.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-2.31 to 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-1.62 to 1.70
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks.
Hide Description The study physician who was blinded to group assignment completed a global knee pain assessment VAS with scores ranging from 0 to 10cm; 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)
Time Frame baseline to 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Note: Data for only 19 participants in the Attention Control group was analyzed at 48 Weeks due to lack of available data.
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: cm
12 Week
-3.14
(-3.88 to -2.41)
-1.44
(-2.18 to -0.70)
24 Week
-2.59
(-3.33 to -1.86)
-2.06
(-2.80 to -1.32)
48 Week
-2.53
(-3.27 to -1.80)
-1.50
(-2.25 to -0.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.71
Confidence Interval (2-Sided) 95%
-2.75 to -0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-1.58 to 0.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.03
Confidence Interval (2-Sided) 95%
-2.09 to 0.02
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks.
Hide Description Timed stand tests measure the time taken to complete ten full stands from a sitting position. Patients began the chair stand seated with their arms folded across their chests, then rose to a standing position and sat back down with their back against the back rest of the chair. The test was completed when the patient stood for the tenth repetition. Chair stand time was measured in seconds, with lower scores indicating improved state. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-second improvement from baseline.)
Time Frame baseline to 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Note: Data for only 18 participants in the Attention Control group was analyzed for the 48-week timepoint to do availability of data.
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 19 19
Mean (95% Confidence Interval)
Unit of Measure: seconds
12 Week
-12.03
(-15.60 to -8.46)
-1.15
(-4.70 to 2.40)
24 Week
-9.87
(-13.44 to -6.30)
-4.75
(-8.30 to -1.20)
48 Week
-9.22
(-12.79 to -5.65)
-3.24
(-6.85 to 0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.88
Confidence Interval (2-Sided) 95%
-15.91 to -5.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.12
Confidence Interval (2-Sided) 95%
-10.15 to -0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.98
Confidence Interval (2-Sided) 95%
-11.06 to -0.91
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks.
Hide Description The 6 minute walk test is a reliable measure of functional exercise capacity. Patients were asked to walk as fast and as far as possible within the 6-minute period and were accompanied by the research staff using a wheel measure that measured distance covered in inches and convereted to yards; higher scores indicated improved state. Higher numbers reported here indicate more improvement from baseline.
Time Frame baseline to 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Note: Data for only 18 patients from Tai chi group was analyzed for 12 week timepoint. Data for 19 patients from the Attention Control group was analyzed at 48 week timepoint.
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 19 20
Mean (95% Confidence Interval)
Unit of Measure: yards
12 Week
48.33
(11.15 to 85.50)
-1.76
(-50.70 to 47.18)
24 Week
53.12
(10.04 to 96.21)
9.41
(-33.48 to 52.30)
48 Week
35.17
(-17.29 to 87.64)
20.56
(-20.73 to 61.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 50.08
Confidence Interval (2-Sided) 95%
-10.34 to 110.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 43.71
Confidence Interval (2-Sided) 95%
-15.07 to 102.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.61
Confidence Interval (2-Sided) 95%
-49.36 to 78.59
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Standing Balance From Baseline to 12, 24, and 48 Weeks.
Hide Description The standing balance test included tandem, semi-tandem, side-by-side, and one-legged stands. Patients were asked to maintain each position for 30 seconds. For each task, the research staff first demonstrated the task, asked the patient if they felt comfortable and ready and then supported the patient while positioning themselves. One point was given if they exceeded 30 seconds and none if they could not or did not attempt the test. Higher numbers reported here indicate more improvement from baseline.
Time Frame baseline to 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Note: Data for only 19 patients in Attention Control group was analyzed for 48-week timepoint due to availability of data.
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12 Weeks
0.15
(-0.16 to 0.46)
0.25
(-0.06 to 0.56)
24 Weeks
0.15
(-0.16 to 0.46)
0.08
(-0.24 to 0.39)
48 Weeks
0.35
(0.04 to 0.66)
0.46
(0.14 to 0.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.54 to 0.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.37 to 0.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.55 to 0.34
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks.
Hide Description The CES-D was used to assess depressive symptoms. It included a 20-item Likert-type scale with scores ranging from 0 to 60. Higher scores indicated greater dysphoria. Negative numbers reported here indicate improvement in condition from baseline. (So -1 indicates a 1-point improvement from baseline.)
Time Frame baseline to 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12 Week
-7.40
(-10.88 to -3.92)
-0.70
(-4.18 to 2.78)
24 Week
-6.40
(-9.88 to -2.92)
-1.10
(-4.58 to 2.38)
48 Week
-7.25
(-10.73 to -3.77)
1.65
(-1.83 to 5.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.70
Confidence Interval (2-Sided) 95%
-11.63 to -1.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.30
Confidence Interval (2-Sided) 95%
-10.23 to -0.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 Week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.90
Confidence Interval (2-Sided) 95%
-13.83 to -3.97
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks.
Hide Description Self-efficacy is important for individuals to adopt and maintain a program of regular physical activity. The patient rates his/her confidence of being physically active in different types of situations on a 5-item scale with responses ranging from "not at all confident" to "extremely confident". The total score is coputed by calculating the average of all 5 questions. A higher score indicates greater self-efficacy. Higher numbers reported here indicate more improvement from baseline.
Time Frame baseline to 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12 Week
0.60
(0.12 to 1.08)
-0.11
(-0.59 to 0.37)
24 Week
0.68
(0.20 to 1.16)
-0.17
(-0.65 to 0.31)
48 Week
0.72
(0.24 to 1.20)
-0.24
(-0.72 to 0.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.03 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.17 to 1.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.28 to 1.64
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks.
Hide Description Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Physical Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.
Time Frame baseline, 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12 Weeks
11.57
(8.08 to 15.06)
4.14
(0.65 to 7.63)
24 Weeks
10.80
(7.31 to 14.29)
6.29
(2.80 to 9.77)
48 Weeks
10.41
(6.92 to 13.90)
4.10
(0.61 to 7.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.43
Confidence Interval (2-Sided) 95%
2.50 to 12.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.51
Confidence Interval (2-Sided) 95%
-0.42 to 9.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.32
Confidence Interval (2-Sided) 95%
1.38 to 11.25
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component
Hide Description Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Mental Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.
Time Frame baseline to 12, 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description:
20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12 Weeks
2.14
(-2.35 to 6.64)
1.93
(-2.56 to 6.43)
24 Weeks
4.39
(-0.11 to 8.89)
4.50
(0.00 to 9.00)
48 Weeks
5.80
(1.31 to 10.30)
1.04
(-3.46 to 5.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 12 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-6.15 to 6.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 24 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-6.47 to 6.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tai Chi, Attention Control
Comments 48 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.77
Confidence Interval (2-Sided) 95%
-1.59 to 11.13
Estimation Comments [Not Specified]
Time Frame during 12 week intervention period
Adverse Event Reporting Description One participant in the Tai Chi group reported an increase in knee pain at the 2 week assessment. This was resolved following modification of that participant's Tai Chi technique.
 
Arm/Group Title Tai Chi Attention Control
Hide Arm/Group Description 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks. 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
All-Cause Mortality
Tai Chi Attention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Tai Chi Attention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tai Chi Attention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/20 (0.00%)    
Musculoskeletal and connective tissue disorders     
increased knee pain * 1 [1]  1/20 (5.00%)  1 0/20 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, increased knee pain
[1]
One participant in the Tai Chi group reported an increase in knee pain at the 2 week assessment. This was resolved following modification of that participant's Tai Chi technique.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Center for Complementary and Alternative Medicine or the National Institutes of Health. The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review or approval of the manuscript.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chenchen Wang, MD, MSc, Associate Professor
Organization: Tufts Medical Center
Phone: 617-636-3251
EMail: cwang2@tuftsmedicalcenter.org
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00362453    
Other Study ID Numbers: R21AT002161 ( U.S. NIH Grant/Contract )
R21AT002161 ( U.S. NIH Grant/Contract )
First Submitted: August 9, 2006
First Posted: August 10, 2006
Results First Submitted: September 25, 2009
Results First Posted: February 8, 2010
Last Update Posted: April 23, 2019