Trial Outcomes & Findings for Tai Chi and Physical Therapy for Knee Osteoarthritis (NCT NCT01258985)
NCT ID: NCT01258985
Last Updated: 2016-08-04
Results Overview
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.
COMPLETED
NA
204 participants
From Week 0 to Week 12
2016-08-04
Participant Flow
Participant milestones
| Measure |
Tai Chi
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
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 Study
STARTED
|
106
|
98
|
|
Overall Study
COMPLETED
|
106
|
98
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tai Chi and Physical Therapy for Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
54 participants
n=5 Participants
|
54 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
41 participants
n=5 Participants
|
31 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
106 participants
n=5 Participants
|
98 participants
n=7 Participants
|
204 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Week 0 to Week 12The 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.
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks
|
-167.2 units on a scale
Interval -190.4 to -144.9
|
-143 units on a scale
Interval -167.4 to -118.6
|
SECONDARY outcome
Timeframe: From Week 0, to Week 12, or to week 24, or to week 52The 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)
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Change in Medical Outcomes Short Form-36 PCS
week 12
|
6.3 units on a scale
Interval 4.6 to 7.9
|
3.1 units on a scale
Interval 1.4 to 4.8
|
|
Change in Medical Outcomes Short Form-36 PCS
24 weeks
|
7.1 units on a scale
Interval 5.1 to 9.0
|
3.4 units on a scale
Interval 1.4 to 5.5
|
|
Change in Medical Outcomes Short Form-36 PCS
52 weeks
|
6.3 units on a scale
Interval 4.4 to 8.3
|
4.3 units on a scale
Interval 2.3 to 6.4
|
SECONDARY outcome
Timeframe: From Week 0, to Week 12, or to week 24, or to week 52The 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.
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Change in 6 Minute Walk
Week 12
|
28.6 meters
Interval 17.9 to 39.2
|
26.1 meters
Interval 14.9 to 37.4
|
|
Change in 6 Minute Walk
Week 24
|
28.9 meters
Interval 16.6 to 41.2
|
24.5 meters
Interval 11.5 to 37.5
|
|
Change in 6 Minute Walk
Week 52
|
27.1 meters
Interval 12.2 to 42.0
|
22.8 meters
Interval 7.0 to 38.6
|
SECONDARY outcome
Timeframe: From Week 0, to Week 12, or to week 24, or to week 52the 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
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Change in 20 Meter Walk Test
12 weeks
|
-1.6 seconds
Interval -2.4 to -0.8
|
-1.1 seconds
Interval -2.0 to -0.2
|
|
Change in 20 Meter Walk Test
24 weeks
|
-2.4 seconds
Interval -3.4 to -1.3
|
-1.2 seconds
Interval -2.2 to -0.1
|
|
Change in 20 Meter Walk Test
52 weeks
|
-2.4 seconds
Interval -3.5 to -1.4
|
-1.0 seconds
Interval -2.1 to 0.2
|
SECONDARY outcome
Timeframe: From Week 0, to Week 12, or to week 24, or to week 52Patients' 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).
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Change in Patient Global VAS
12 weeks
|
-0.3 units on a scale
Interval -0.3 to -0.2
|
-0.2 units on a scale
Interval -0.3 to -0.2
|
|
Change in Patient Global VAS
24 weeks
|
-2.4 units on a scale
Interval -2.93 to -1.88
|
-1.73 units on a scale
Interval -2.29 to -1.17
|
|
Change in Patient Global VAS
52 weeks
|
-1.84 units on a scale
Interval -2.48 to -1.21
|
-1.31 units on a scale
Interval -1.96 to -0.66
|
SECONDARY outcome
Timeframe: From Week 0, to Week 12, or to week 24, or to week 52Beck 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.
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Change in Beck II Depression Inventory
12 weeks
|
-2.2 units on a scale
Interval -3.7 to -0.9
|
0.5 units on a scale
Interval -1.0 to 2.0
|
|
Change in Beck II Depression Inventory
24 weeks
|
-1.7 units on a scale
Interval -3.1 to -0.4
|
0.2 units on a scale
Interval -1.3 to 1.7
|
|
Change in Beck II Depression Inventory
52 weeks
|
-1.1 units on a scale
Interval -2.7 to 0.5
|
-0.003 units on a scale
Interval -1.6 to 1.6
|
SECONDARY outcome
Timeframe: From Week 0, to Week 12, or to week 24, or to week 52The 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).
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Change in Arthritis Self-Efficacy Scale
12 weeks
|
1.3 units on a scale
Interval 0.8 to 1.8
|
0.8 units on a scale
Interval 0.3 to 1.4
|
|
Change in Arthritis Self-Efficacy Scale
24 weeks
|
0.9 units on a scale
Interval 0.4 to 1.4
|
0.9 units on a scale
Interval 0.4 to 1.4
|
|
Change in Arthritis Self-Efficacy Scale
52 weeks
|
1.0 units on a scale
Interval 0.5 to 1.5
|
0.7 units on a scale
Interval 0.2 to 1.2
|
SECONDARY outcome
Timeframe: From Week 0, to Week 12, or to week 24, or to week 52The 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)
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)
12 weeks
|
1.6 units on a scale
Interval -0.1 to 3.2
|
-0.03 units on a scale
Interval -1.7 to 1.7
|
|
Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)
24 weeks
|
0.4 units on a scale
Interval -1.5 to 2.2
|
-0.7 units on a scale
Interval -2.7 to 1.4
|
|
Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)
52 weeks
|
-0.1 units on a scale
Interval -1.9 to 1.8
|
-1.5 units on a scale
Interval -3.4 to 0.4
|
SECONDARY outcome
Timeframe: From Week 0, to Week 12, or to week 24, or to week 52The 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.
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function
12 weeks
|
-608.3 units on a scale
Interval -695.3 to -521.4
|
-114.1 units on a scale
Interval -240.0 to 118.0
|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function
24 weeks
|
-586.8 units on a scale
Interval -669.5 to -504.1
|
-455.7 units on a scale
Interval -543.1 to -368.4
|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function
52 weeks
|
-532.3 units on a scale
Interval -625.9 to -438.7
|
-444.0 units on a scale
Interval -541.3 to -346.7
|
SECONDARY outcome
Timeframe: Week 0The 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.
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Outcome Expectation Scale
|
3.9 units on a scale
Standard Deviation 0.5
|
3.9 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: From Week 0, to week 24 or to week 52The 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.
Outcome measures
| Measure |
Tai Chi
n=106 Participants
12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi
|
Physical Therapy
n=98 Participants
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
|
|---|---|---|
|
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale
24 weeks
|
-158.6 units on a scale
Interval -182.9 to -134.3
|
-124.3 units on a scale
Interval -150.0 to -98.5
|
|
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale
52 weeks
|
-138.8 units on a scale
Interval -166.7 to -110.8
|
-121.0 units on a scale
Interval -150.0 to -91.9
|
Adverse Events
Tai Chi
Physical Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place