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Tai Chi and Physical Therapy for Knee Osteoarthritis (TCPT)

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ClinicalTrials.gov Identifier: NCT01258985
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : August 4, 2016
Last Update Posted : August 4, 2016
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
Interventions Behavioral: Tai Chi
Behavioral: Physical Therapy
Enrollment 204
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Period Title: Overall Study
Started 106 98
Completed 106 98
Not Completed 0 0
Arm/Group Title Tai Chi Physical Therapy Total
Hide Arm/Group Description

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Total of all reporting groups
Overall Number of Baseline Participants 106 98 204
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 98 participants 204 participants
60.3  (10.5) 60.1  (10.5) 60.2  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 98 participants 204 participants
Female
75
  70.8%
68
  69.4%
143
  70.1%
Male
31
  29.2%
30
  30.6%
61
  29.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 98 participants 204 participants
White 54 54 108
Black 41 31 72
Asian 4 2 6
Other 7 11 18
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 106 participants 98 participants 204 participants
106 98 204
1.Primary Outcome
Title Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks
Hide Description The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0–500), stiffness (0–200), and function (0–1700), with higher scores indicating more severe disease.
Time Frame From Week 0 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-167.2
(-190.4 to -144.9)
-143
(-167.4 to -118.6)
2.Secondary Outcome
Title Change in Medical Outcomes Short Form-36 PCS
Hide Description The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)
Time Frame From Week 0, to Week 12, or to week 24, or to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
week 12
6.3
(4.6 to 7.9)
3.1
(1.4 to 4.8)
24 weeks
7.1
(5.1 to 9.0)
3.4
(1.4 to 5.5)
52 weeks
6.3
(4.4 to 8.3)
4.3
(2.3 to 6.4)
3.Secondary Outcome
Title Change in 6 Minute Walk
Hide Description The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded.
Time Frame From Week 0, to Week 12, or to week 24, or to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (95% Confidence Interval)
Unit of Measure: meters
Week 12
28.6
(17.9 to 39.2)
26.1
(14.9 to 37.4)
Week 24
28.9
(16.6 to 41.2)
24.5
(11.5 to 37.5)
Week 52
27.1
(12.2 to 42.0)
22.8
(7.0 to 38.6)
4.Secondary Outcome
Title Change in 20 Meter Walk Test
Hide Description the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability
Time Frame From Week 0, to Week 12, or to week 24, or to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (95% Confidence Interval)
Unit of Measure: seconds
12 weeks
-1.6
(-2.4 to -0.8)
-1.1
(-2.0 to -0.2)
24 weeks
-2.4
(-3.4 to -1.3)
-1.2
(-2.2 to -0.1)
52 weeks
-2.4
(-3.5 to -1.4)
-1.0
(-2.1 to 0.2)
5.Secondary Outcome
Title Change in Patient Global VAS
Hide Description Patients' global assessment score (Patient Global VAS) was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).
Time Frame From Week 0, to Week 12, or to week 24, or to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12 weeks
-0.3
(-0.3 to -0.2)
-0.2
(-0.3 to -0.2)
24 weeks
-2.4
(-2.93 to -1.88)
-1.73
(-2.29 to -1.17)
52 weeks
-1.84
(-2.48 to -1.21)
-1.31
(-1.96 to -0.66)
6.Secondary Outcome
Title Change in Beck II Depression Inventory
Hide Description Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms.
Time Frame From Week 0, to Week 12, or to week 24, or to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12 weeks
-2.2
(-3.7 to -0.9)
0.5
(-1 to 2)
24 weeks
-1.7
(-3.1 to -0.4)
0.2
(-1.3 to 1.7)
52 weeks
-1.1
(-2.7 to 0.5)
-0.003
(-1.6 to 1.6)
7.Secondary Outcome
Title Change in Arthritis Self-Efficacy Scale
Hide Description The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy).
Time Frame From Week 0, to Week 12, or to week 24, or to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12 weeks
1.3
(0.8 to 1.8)
0.8
(0.3 to 1.4)
24 weeks
0.9
(0.4 to 1.4)
0.9
(0.4 to 1.4)
52 weeks
1.0
(0.5 to 1.5)
0.7
(0.2 to 1.2)
8.Secondary Outcome
Title Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)
Hide Description The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)
Time Frame From Week 0, to Week 12, or to week 24, or to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12 weeks
1.6
(-0.1 to 3.2)
-0.03
(-1.7 to 1.7)
24 weeks
0.4
(-1.5 to 2.2)
-0.7
(-2.7 to 1.4)
52 weeks
-0.1
(-1.9 to 1.8)
-1.5
(-3.4 to 0.4)
9.Secondary Outcome
Title Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function
Hide Description The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0–500), stiffness (0–200), and function (0–1700), with higher scores indicating more severe disease.
Time Frame From Week 0, to Week 12, or to week 24, or to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12 weeks
-608.3
(-695.3 to -521.4)
-114.1
(-240 to 118)
24 weeks
-586.8
(-669.5 to -504.1)
-455.7
(-543.1 to -368.4)
52 weeks
-532.3
(-625.9 to -438.7)
-444.0
(-541.3 to -346.7)
10.Secondary Outcome
Title Outcome Expectation Scale
Hide Description The Outcome Expectations for Exercise Scale (range, 1 to 5, with 1 indicating no expectations for exercise and 5 the highest expectations for exercise) is a self-report measure of outcome expectations for exercise.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.9  (0.5) 3.9  (0.6)
11.Secondary Outcome
Title Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale
Hide Description The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
Time Frame From Week 0, to week 24 or to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description:

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Overall Number of Participants Analyzed 106 98
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
24 weeks
-158.6
(-182.9 to -134.3)
-124.3
(-150.0 to -98.5)
52 weeks
-138.8
(-166.7 to -110.8)
-121.0
(-150.0 to -91.9)
Time Frame 12 weeks
Adverse Event Reporting Description participants are monitored weekly during intervention for adverse events. All are recorded on a case report form and evaluated according to Institutional Review Board mandated criteria. No systematic ascertainment of adverse events is undertaken after the intervention period based on the principle that all would be unrelated to the intervention.
 
Arm/Group Title Tai Chi Physical Therapy
Hide Arm/Group Description

12 weeks of Tai Chi classes

Tai Chi: 12 weeks of Tai Chi

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

All-Cause Mortality
Tai Chi Physical Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tai Chi Physical Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/98 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tai Chi Physical Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/98 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: chenchen wang
Organization: Tufts Medical Center
Phone: 617-636-3251
EMail: cwang2@tuftsmedicalcenter.org
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01258985     History of Changes
Other Study ID Numbers: 1R01AT005521-01A1 ( U.S. NIH Grant/Contract )
R01AT005521 ( U.S. NIH Grant/Contract )
UL1TR000073 ( U.S. NIH Grant/Contract )
UL1TR001064 ( U.S. NIH Grant/Contract )
First Submitted: December 10, 2010
First Posted: December 13, 2010
Results First Submitted: November 4, 2015
Results First Posted: August 4, 2016
Last Update Posted: August 4, 2016