Tai Chi and Physical Therapy for Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Tai Chi and Physical Therapy for Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Behavioral: Tai Chi
* Behavioral: Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40 years and older American College of Rheumatology criteria for symptomatic Knee OA: 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 lying in bed at night;101 radiographic evidence of grade I-III tibiofemoral or patellofemoral OA: defined as the presence of osteophytes in the tibiofemoral compartment and /or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views101 WOMAC pain subscale score >= 40 (visual analog version) on at least 1 of 5 questions (range 0 to 100 each) Clinical examination confirming knee pain or discomfort or instability referable to the knee joint Physically able to participate in both the Tai Chi and Standard PT programs Willing to undergo testing and intervention procedures and 1.willing to abstain from Tai Chi until completion of the program, if randomized to Standard PT regimen. 2. willing to abstain from Standard PT regimen until completion of the program, if randomized to Tai Chi Exclusion Criteria: Prior experience with physical therapy, Tai Chi or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong and yoga since these share some of the principles of Tai Chi. Serious medical conditions limiting the ability and safety to participate in either the Tai Chi or Standard PT regimen programs as determined by primary care physicians; these include dementia, neurological disease, symptomatic heart or vascular disease (angina, peripheral vascular disease, congestive heart failure), severe hypertension, recent stroke, severe insulin-dependent diabetes mellitus, psychiatric disease, renal disease, liver disease, active cancer and anemia 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)102 Inability to walk without a cane or other assistive device 100% of the time during the baseline assessments Enrollment in any other clinical trial within the last 30 days Plan to permanently relocate from the region during the trial period Positive pregnancy test or planning pregnancy within the study period Not English-Speaking

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tai Chi<br>12 weeks of Tai Chi classes | Behavioral: Tai Chi<br>* 12 weeks of Tai Chi<br>|
| Active Comparator: Physical Therapy<br>6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise | Behavioral: Physical Therapy<br>* 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Therapy, Knee, Knee osteoarthritis, osteoarthritis, Knee pain, Tai Chi, mind-body exercise