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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
204
12 weeks of Tai Chi
6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Tufts Medical Center
Boston, Massachusetts, United States
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.
Time frame: From Week 0 to Week 12
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)
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
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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.
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Week 0, to week 24 or to week 52