Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AT005521 | U.S. NIH Grant/Contract | View source | |
| UL1TR000073 | U.S. NIH Grant/Contract | View source | |
| UL1TR001064 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We will conduct a large randomized controlled trial comparing the effectiveness and cost-effectiveness of Tai Chi mind-body exercise and standard-of-care Physical Therapy for Knee Osteoarthritis.
Osteoarthritis (OA) causes pain and long-term disability, and the public health impact will increase as the population ages. In addition to inconsistent effectiveness, current treatments such as nonsteroidal anti-inflammatory drugs, knee replacement, and physical therapy may be expensive, result in serious adverse effects, reduce physical function, and fail to improve mental well-being. Finding effective treatments to maintain function and quality of life in OA patients is one of the national priorities identified this year by the Institute of Medicine.
We propose to conduct the first comparative effectiveness and cost-effectiveness trial of Tai Chi vs. physical therapy (PT) in a large symptomatic Knee OA population. A single-blind, randomized, controlled trial of Tai Chi vs. Physical Therapy will be conducted in 180 patients who meet the American College of Rheumatology criteria for Knee OA. Patients will be randomized to 12 weeks of treatment with Tai Chi (2x/week) or Standard Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorous supervised home exercise) with 24 and 52 week follow-ups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai Chi | Active Comparator | 12 weeks of Tai Chi classes |
|
| Physical Therapy | Active Comparator | 6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai Chi | Behavioral | 12 weeks of Tai Chi |
| |
| Physical Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks | 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. | From Week 0 to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medical Outcomes Short Form-36 PCS | 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) | From Week 0, to Week 12, or to week 24, or to week 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chenchen Wang, MD, MSc | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15006825 | Background | Wang C, Collet JP, Lau J. The effect of Tai Chi on health outcomes in patients with chronic conditions: a systematic review. Arch Intern Med. 2004 Mar 8;164(5):493-501. doi: 10.1001/archinte.164.5.493. | |
| 15741197 | Background | Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL. Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford). 2005 May;44(5):685-7. doi: 10.1093/rheumatology/keh572. Epub 2005 Mar 1. No abstract available. |
Not provided
Not provided
De-identified participant data will be made available upon request.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tai Chi | 12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tai Chi | 12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | From Week 0 to Week 12 |
|
12 weeks
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tai Chi | 12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| chenchen wang | Tufts Medical Center | 617-636-3251 | cwang2@tuftsmedicalcenter.org |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026302 | Tai Ji |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise |
|
| Change in 6 Minute Walk |
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. |
| From Week 0, to Week 12, or to week 24, or to week 52 |
| Change in 20 Meter Walk Test | 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 | From Week 0, to Week 12, or to week 24, or to week 52 |
| Change in Patient Global VAS | 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). | From Week 0, to Week 12, or to week 24, or to week 52 |
| Change in Beck II Depression Inventory | 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. | From Week 0, to Week 12, or to week 24, or to week 52 |
| Change in Arthritis Self-Efficacy Scale | 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). | From Week 0, to Week 12, or to week 24, or to week 52 |
| Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) | 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) | From Week 0, to Week 12, or to week 24, or to week 52 |
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function | 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. | From Week 0, to Week 12, or to week 24, or to week 52 |
| Outcome Expectation Scale | 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. | Week 0 |
| Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale | 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. | From Week 0, to week 24 or to week 52 |
| 18487901 | Background | Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-229. doi: 10.1159/000134302. |
| 20818876 | Background | Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, Lee Y, McAlindon T. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010 Aug 19;363(8):743-54. doi: 10.1056/NEJMoa0912611. |
| 19877092 | Background | Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, McAlindon T. Tai Chi is effective in treating knee osteoarthritis: a randomized controlled trial. Arthritis Rheum. 2009 Nov 15;61(11):1545-53. doi: 10.1002/art.24832. |
| 18664276 | Background | Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, Okparavero A, McAlindon T. Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial. BMC Musculoskelet Disord. 2008 Jul 29;9:108. doi: 10.1186/1471-2474-9-108. |
| 26315282 | Background | Reid KF, Price LL, Harvey WF, Driban JB, Hau C, Fielding RA, Wang C. Muscle Power Is an Independent Determinant of Pain and Quality of Life in Knee Osteoarthritis. Arthritis Rheumatol. 2015 Dec;67(12):3166-73. doi: 10.1002/art.39336. |
| 29407226 | Derived | Lee AC, Harvey WF, Price LL, Han X, Driban JB, Iversen MD, Desai SA, Knopp HE, Wang C. Dose-Response Effects of Tai Chi and Physical Therapy Exercise Interventions in Symptomatic Knee Osteoarthritis. PM R. 2018 Jul;10(7):712-723. doi: 10.1016/j.pmrj.2018.01.003. Epub 2018 Jan 31. |
| 28506776 | Derived | Lee AC, Harvey WF, Price LL, Han X, Driban JB, Wong JB, Chung M, McAlindon TE, Wang C. Mindfulness Is Associated With Treatment Response From Nonpharmacologic Exercise Interventions in Knee Osteoarthritis. Arch Phys Med Rehabil. 2017 Nov;98(11):2265-2273.e1. doi: 10.1016/j.apmr.2017.04.014. Epub 2017 May 12. |
| 28501708 | Derived | Lee AC, Driban JB, Price LL, Harvey WF, Rodday AM, Wang C. Responsiveness and Minimally Important Differences for 4 Patient-Reported Outcomes Measurement Information System Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis. J Pain. 2017 Sep;18(9):1096-1110. doi: 10.1016/j.jpain.2017.05.001. Epub 2017 May 10. |
| 27183035 | Derived | Wang C, Schmid CH, Iversen MD, Harvey WF, Fielding RA, Driban JB, Price LL, Wong JB, Reid KF, Rones R, McAlindon T. Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis: A Randomized Trial. Ann Intern Med. 2016 Jul 19;165(2):77-86. doi: 10.7326/M15-2143. Epub 2016 May 17. |
| 26369412 | Derived | Driban JB, Morgan N, Price LL, Cook KF, Wang C. Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity. BMC Musculoskelet Disord. 2015 Sep 14;16:253. doi: 10.1186/s12891-015-0715-y. |
| 25199526 | Derived | Wang C, Iversen MD, McAlindon T, Harvey WF, Wong JB, Fielding RA, Driban JB, Price LL, Rones R, Gamache T, Schmid CH. Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial. BMC Complement Altern Med. 2014 Sep 8;14:333. doi: 10.1186/1472-6882-14-333. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Medical Outcomes Short Form-36 PCS | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | From Week 0, to Week 12, or to week 24, or to week 52 |
|
|
|
| Secondary | Change in 6 Minute Walk | 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. | Posted | Mean | 95% Confidence Interval | meters | From Week 0, to Week 12, or to week 24, or to week 52 |
|
|
|
| Secondary | Change in 20 Meter Walk Test | 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 | Posted | Mean | 95% Confidence Interval | seconds | From Week 0, to Week 12, or to week 24, or to week 52 |
|
|
|
| Secondary | Change in Patient Global VAS | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | From Week 0, to Week 12, or to week 24, or to week 52 |
|
|
|
| Secondary | Change in Beck II Depression Inventory | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | From Week 0, to Week 12, or to week 24, or to week 52 |
|
|
|
| Secondary | Change in Arthritis Self-Efficacy Scale | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | From Week 0, to Week 12, or to week 24, or to week 52 |
|
|
|
| Secondary | Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | From Week 0, to Week 12, or to week 24, or to week 52 |
|
|
|
| Secondary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | From Week 0, to Week 12, or to week 24, or to week 52 |
|
|
|
| Secondary | Outcome Expectation Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | Week 0 |
|
|
|
| Secondary | Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | From Week 0, to week 24 or to week 52 |
|
|
|
| 0 |
| 106 |
| 0 |
| 106 |
| EG001 | 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 | 0 | 98 | 0 | 98 |
Not provided
Not provided
| D012046 |
| Rehabilitation |
| 52 weeks |
|
| Week 52 |
|
| 52 weeks |
|
| 52 weeks |
|
| 52 weeks |
|
| 52 weeks |
|
| 52 weeks |
|
| 52 weeks |
|