Knee Osteoarthritis
Conditions
Brief summary
The purpose of this study was to compare the safety and effectiveness of Tai Chi with an Attention Control intervention consisting of a stretching and wellness education program involving 40 patients with osteoarthritis (OA) of the knee. We hypothesized that the participants receiving Tai Chi would show greater improvement in knee pain, physical and psychological functioning, and health-related quality of life than participants in the Attention Control group, and that the benefit would be mediated by effects on muscle function, musculoskeletal flexibility and mental health.
Detailed description
Osteoarthritis (OA) is the most common form of arthritis in the United States, affecting 21 million older people. Symptomatic knee OA in the elderly is one of the most frequent causes of loss of independence and physical disability. There are currently no satisfactory pharmacological or non-pharmacological therapies for knee OA. New strategies to improve functional capacity, quality of life and reduce long-term disability in people with knee OA are urgently needed. Our long-term goal is to demonstrate the physical and psychological benefits of Tai Chi exercise as a complementary treatment for people with knee OA. Tai Chi is a traditional Chinese discipline with both physical and mental components that appear to benefit a variety of conditions. The physical component provides exercise that is consistent with recommendations for OA (range of motion, flexibility, muscle conditioning and aerobic cardiovascular exercise), while the mental component has the potential to increase psychological well-being, life satisfaction, and perceptions of health. These effects are especially pertinent for the treatment of older adults with knee OA. Over a three-year period, 40 patients with symptomatic knee OA were randomly assigned to receive a 12-week Tai Chi program or stretching and wellness education program. Outcome measurements were obtained at baseline and on completion of the 12-week program, as well as 24 and 48 week follow-up periods. We compared changes in knee pain, stiffness, and physical function using the well-validated Western Ontario and McMaster Index (WOMAC), as well as clinical knee examination, lower extremity function, knee joint proprioception, and health related quality of life.
Interventions
BEHAVIORALTai Chi versus Attention Control
60 minutes, twice a week for 12 weeks.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 55 or older * Body Mass Index (BMI) \<= 40 kg/m * Pain on more than half the days of the past month during at least one of the following activities (walking, going up or down stairs, standing upright, or in bed at night * Radiographic evidence of knee OA, defined as the presence of osteophytes in the tibiofemoral compartment and/or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views * WOMAC pain subscale score, at least 1 of 5 (range 0 to 100 each) \>= 40 (visual analog version) * Physically able to participate in both the Tai Chi and stretching and education programs * Willing to complete the 12-week study, including twice a week Tai Chi or stretching and education sessions * Willing to abstain from Tai Chi until completion of the program, if randomized to the stretching and education sessions * Willing to abstain from stretching and education sessions until completion of the program, if randomized to Tai Chi
Exclusion criteria
* Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine such as Qi gong, yoga, and acupuncture since these share some of the principles of Tai Chi * Dementia, neurological disease, cardiovascular disease, pulmonary disease, metabolic disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in either the Tai Chi or stretching programs as determined by primary care physicians * Any intra-articular steroid injections in the previous 3 months or reconstructive surgery on the affected knee * Any intra-articular Synvisc or Hyalgan injections in the previous 6 months * Inability to pass the Mini-Mental Status examination (with a score below 24) * Enrollment in any other clinical trial within the last 30 days * Plan to permanently relocate from the region during the trial period * Non English Speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks | between baseline and 12 weeks. | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. | baseline to 12, 24, 48 weeks | 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.) |
| Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks. | baseline to 24, 48 weeks | 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.) |
| Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) | baseline to 12, 24, 48 weeks | 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.) |
| Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. | baseline to 12, 24, 48 weeks | 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.) |
| Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. | baseline to 12, 24, 48 weeks | 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.) |
| Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. | from baseline to 12, 24, 48 weeks | 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.) |
| Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. | baseline to 12, 24, 48 weeks | 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. |
| Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. | baseline to 12, 24, 48 weeks | 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.) |
| Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. | baseline to 12, 24, 48 weeks | 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. |
| Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. | baseline, 12, 24, 48 weeks | 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. |
| Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component | baseline to 12, 24, 48 weeks | 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. |
| Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. | baseline to 12, 24, 48 weeks | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Tai Chi 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 |
| Attention Control 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Tai Chi | Attention Control | Total |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 8.1 | 68 years STANDARD_DEVIATION 7 | 65 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks
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.
Population: We analyzed the data on an intent-to-treat basis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks | -157.25 mm |
| Attention Control | Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks | -38.45 mm |
p-value: 0.000595% CI: [-183.66, -53.94]Mixed Models Analysis
Secondary
Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks.
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. | 12 Week | 48.33 yards |
| Tai Chi | Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. | 24 Week | 53.12 yards |
| Tai Chi | Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. | 48 Week | 35.17 yards |
| Attention Control | Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. | 12 Week | -1.76 yards |
| Attention Control | Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. | 24 Week | 9.41 yards |
| Attention Control | Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. | 48 Week | 20.56 yards |
Comparison: 12 Weekp-value: 0.195% CI: [-10.34, 110.5]Mixed Models Analysis
Comparison: 24 Weekp-value: 0.195% CI: [-15.07, 102.5]Mixed Models Analysis
Comparison: 48 Weeksp-value: 0.795% CI: [-49.36, 78.59]Mixed Models Analysis
Secondary
Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks.
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. | 12 Week | -7.40 units on a scale |
| Tai Chi | Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. | 24 Week | -6.40 units on a scale |
| Tai Chi | Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. | 48 Week | -7.25 units on a scale |
| Attention Control | Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. | 12 Week | -0.70 units on a scale |
| Attention Control | Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. | 24 Week | -1.10 units on a scale |
| Attention Control | Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. | 48 Week | 1.65 units on a scale |
Comparison: 12 Weekp-value: 0.00995% CI: [-11.63, -1.77]Mixed Models Analysis
Comparison: 24 Weeksp-value: 0.0495% CI: [-10.23, -0.37]Mixed Models Analysis
Comparison: 48 Weekp-value: 0.000695% CI: [-13.83, -3.97]Mixed Models Analysis
Secondary
Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component | 12 Weeks | 2.14 units on a scale |
| Tai Chi | Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component | 24 Weeks | 4.39 units on a scale |
| Tai Chi | Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component | 48 Weeks | 5.80 units on a scale |
| Attention Control | Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component | 12 Weeks | 1.93 units on a scale |
| Attention Control | Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component | 24 Weeks | 4.50 units on a scale |
| Attention Control | Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component | 48 Weeks | 1.04 units on a scale |
Comparison: 12 Weeksp-value: 0.995% CI: [-6.15, 6.57]Mixed Models Analysis
Comparison: 24 Weeksp-value: 195% CI: [-6.47, 6.25]Mixed Models Analysis
Comparison: 48 Weeksp-value: 0.195% CI: [-1.59, 11.13]Mixed Models Analysis
Secondary
Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks.
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. | 12 Weeks | 11.57 units on a scale |
| Tai Chi | Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. | 24 Weeks | 10.80 units on a scale |
| Tai Chi | Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. | 48 Weeks | 10.41 units on a scale |
| Attention Control | Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. | 12 Weeks | 4.14 units on a scale |
| Attention Control | Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. | 24 Weeks | 6.29 units on a scale |
| Attention Control | Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. | 48 Weeks | 4.10 units on a scale |
Comparison: 12 Weeksp-value: 0.00495% CI: [2.5, 12.36]Mixed Models Analysis
Comparison: 24 Weeksp-value: 0.0895% CI: [-0.42, 9.45]Mixed Models Analysis
Comparison: 48 Weeksp-value: 0.0195% CI: [1.38, 11.25]Mixed Models Analysis
Secondary
Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS)
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) | 12 Week | -2.98 cm |
| Tai Chi | Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) | 24 Week | -2.36 cm |
| Tai Chi | Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) | 48 Week | -1.65 cm |
| Attention Control | Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) | 12 Week | -0.83 cm |
| Attention Control | Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) | 24 Week | -1.71 cm |
| Attention Control | Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) | 48 Week | -1.70 cm |
Comparison: 12 Weekp-value: 0.0195% CI: [-3.82, -0.49]Mixed Models Analysis
Comparison: 24 Weekp-value: 0.495% CI: [-2.31, 1.02]Mixed Models Analysis
Comparison: 48 weeksp-value: 195% CI: [-1.62, 1.7]Mixed Models Analysis
Secondary
Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks.
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
Population: Note: Data for only 19 participants in the Attention Control group was analyzed at 48 Weeks due to lack of available data.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. | 24 Week | -2.59 cm |
| Tai Chi | Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. | 12 Week | -3.14 cm |
| Tai Chi | Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. | 48 Week | -2.53 cm |
| Attention Control | Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. | 12 Week | -1.44 cm |
| Attention Control | Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. | 24 Week | -2.06 cm |
| Attention Control | Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. | 48 Week | -1.50 cm |
Comparison: 12 Weekp-value: 0.00295% CI: [-2.75, -0.66]Mixed Models Analysis
Comparison: 24 Weekp-value: 0.395% CI: [-1.58, 0.51]Mixed Models Analysis
Comparison: 48 Weekp-value: 0.0695% CI: [-2.09, 0.02]Mixed Models Analysis
Secondary
Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks.
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. | 12 Week | 0.60 units on a scale |
| Tai Chi | Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. | 24 Week | 0.68 units on a scale |
| Tai Chi | Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. | 48 Week | 0.72 units on a scale |
| Attention Control | Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. | 12 Week | -0.11 units on a scale |
| Attention Control | Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. | 24 Week | -0.17 units on a scale |
| Attention Control | Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. | 48 Week | -0.24 units on a scale |
Comparison: 12 Weeksp-value: 0.0495% CI: [0.03, 1.39]Mixed Models Analysis
Comparison: 24 Weeksp-value: 0.0295% CI: [0.17, 1.53]Mixed Models Analysis
Comparison: 48 Weeksp-value: 0.00795% CI: [0.28, 1.64]Mixed Models Analysis
Secondary
Change in Standing Balance From Baseline to 12, 24, and 48 Weeks.
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
Population: Note: Data for only 19 patients in Attention Control group was analyzed for 48-week timepoint due to availability of data.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. | 12 Weeks | 0.15 units on a scale |
| Tai Chi | Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. | 24 Weeks | 0.15 units on a scale |
| Tai Chi | Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. | 48 Weeks | 0.35 units on a scale |
| Attention Control | Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. | 12 Weeks | 0.25 units on a scale |
| Attention Control | Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. | 24 Weeks | 0.08 units on a scale |
| Attention Control | Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. | 48 Weeks | 0.46 units on a scale |
Comparison: 12 Weeksp-value: 0.795% CI: [-0.54, 0.34]Mixed Models Analysis
Comparison: 24 Weeksp-value: 0.795% CI: [-0.37, 0.52]Mixed Models Analysis
Comparison: 48 weeksp-value: 0.695% CI: [-0.55, 0.34]Mixed Models Analysis
Secondary
Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks.
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
Population: Note: Data for only 18 participants in the Attention Control group was analyzed for the 48-week timepoint to do availability of data.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. | 12 Week | -12.03 seconds |
| Tai Chi | Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. | 24 Week | -9.87 seconds |
| Tai Chi | Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. | 48 Week | -9.22 seconds |
| Attention Control | Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. | 12 Week | -1.15 seconds |
| Attention Control | Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. | 24 Week | -4.75 seconds |
| Attention Control | Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. | 48 Week | -3.24 seconds |
Comparison: 12 Weekp-value: 0.0000595% CI: [-15.91, -5.84]Mixed Models Analysis
Comparison: 24 Weekp-value: 0.0595% CI: [-10.15, -0.08]Mixed Models Analysis
Comparison: 48 Weekp-value: 0.0295% CI: [-11.06, -0.91]Mixed Models Analysis
Secondary
Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks.
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. | 12 Week | -506.75 mm |
| Tai Chi | Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. | 24 Week | -440.50 mm |
| Tai Chi | Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. | 48 Week | -405.85 mm |
| Attention Control | Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. | 12 Week | -182.15 mm |
| Attention Control | Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. | 24 Week | -257.30 mm |
| Attention Control | Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. | 48 Week | -300.55 mm |
Comparison: 12 Weekp-value: 0.00195% CI: [-513.98, -135.22]Mixed Models Analysis
Comparison: 24 Weekp-value: 0.0695% CI: [-372.58, 6.18]Mixed Models Analysis
Comparison: 48 weekp-value: 0.395% CI: [-294.68, 84.08]Mixed Models Analysis
Secondary
Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks.
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
Population: The 12-Week WOMAC scores are listed under Primary Outcome. The 24-Week and 48-Week scores are listed as Secondary Outcomes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks. | 24 Weeks | -131.55 mm |
| Tai Chi | Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks. | 48 Weeks | -115.35 mm |
| Attention Control | Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks. | 24 Weeks | -64.60 mm |
| Attention Control | Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks. | 48 Weeks | -69.20 mm |
Comparison: 24 Weekp-value: 0.0595% CI: [-131.81, -2.09]Mixed Models Analysis
Comparison: 48 Weekp-value: 0.295% CI: [-111.01, 18.71]Mixed Models Analysis
Secondary
Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks.
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. | 12 Week | -73.05 mm |
| Tai Chi | Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. | 24 Week | -65.00 mm |
| Tai Chi | Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. | 48 Week | -64.15 mm |
| Attention Control | Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. | 12 Week | -50.15 mm |
| Attention Control | Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. | 24 Week | -50.20 mm |
| Attention Control | Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. | 48 Week | -60.50 mm |
Comparison: 12 weekp-value: 0.195% CI: [-53.04, 7.24]Mixed Models Analysis
Comparison: 24 weekp-value: 0.395% CI: [-44.94, 15.34]Mixed Models Analysis
Comparison: 48 Weekp-value: 0.895% CI: [-33.79, 26.49]Mixed Models Analysis