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Tai Chi and Physical Therapy for Knee Osteoarthritis (TCPT)

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ClinicalTrials.gov Identifier: NCT01258985
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : August 4, 2016
Last Update Posted : August 4, 2016
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Tufts Medical Center

December 10, 2010
December 13, 2010
November 4, 2015
August 4, 2016
August 4, 2016
March 2011
September 2014   (Final data collection date for primary outcome measure)
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks [ Time Frame: From Week 0 to Week 12 ]
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.
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks [ Time Frame: Week 0, Week 12 ]
Pain
Complete list of historical versions of study NCT01258985 on ClinicalTrials.gov Archive Site
  • Change in Medical Outcomes Short Form-36 PCS [ Time Frame: From Week 0, to Week 12, or to week 24, or to week 52 ]
    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)
  • Change in 6 Minute Walk [ Time Frame: From Week 0, to Week 12, or to week 24, or to week 52 ]
    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.
  • Change in 20 Meter Walk Test [ Time Frame: From Week 0, to Week 12, or to week 24, or to week 52 ]
    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
  • Change in Patient Global VAS [ Time Frame: From Week 0, to Week 12, or to week 24, or to week 52 ]
    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).
  • Change in Beck II Depression Inventory [ Time Frame: From Week 0, to Week 12, or to week 24, or to week 52 ]
    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.
  • Change in Arthritis Self-Efficacy Scale [ Time Frame: From Week 0, to Week 12, or to week 24, or to week 52 ]
    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).
  • Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) [ Time Frame: From Week 0, to Week 12, or to week 24, or to week 52 ]
    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)
  • Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function [ Time Frame: From Week 0, to Week 12, or to week 24, or to week 52 ]
    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.
  • Outcome Expectation Scale [ Time Frame: Week 0 ]
    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.
  • Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale [ Time Frame: From Week 0, to week 24 or to week 52 ]
    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.
  • Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale at follow-up [ Time Frame: Week 0, Week 24, Week 52 ]
  • Body Mass Index [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
  • Medical Outcomes Short Form-36 [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Quality of Life
  • PROMIS Physical Functioning Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    physical function
  • 6 Minute Walk [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Walking ability and endurance
  • 20 Meter Walk [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    walking ability
  • Chair Stand Test [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Lower extremity physical function
  • Berg Balance Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Balance
  • Qualitative Gait Analysis [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Video-taped gait analysis
  • Postural Sway [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Balance and postural sway
  • Muscle Strength and Leg Power [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    muscle strength and power
  • Beck II Depression Inventory [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Depression
  • Perceived Stress Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Stress
  • PROMIS Pain Impact Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Pain
  • PROMIS Distress-Depression Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Depression
  • PROMIS Distress-Anxiety Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Anxiety
  • PROMIS Sleep Disturbance Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Sleep quality
  • PROMIS Social Roles Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Social Roles and Satisfaction
  • Arthritis Self-Efficacy Scale function subscale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Self-efficacy
  • Medical Outcome Study Social Support Survey [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Social Support
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function and stiffness [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    physical function and stiffness
  • PROMIS Health Assessment Questionnaire [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Health Status
  • Health Assessment Questionnaire Utilization [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Healthcare cost and utilization
  • Outcome Expectation Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Participant expectations
  • Champs Activity Questionnaire for Older Adults [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Physical Activity Levels
Not Provided
Not Provided
 
Tai Chi and Physical Therapy for Knee Osteoarthritis
Tai Chi and Physical Therapy for Knee Osteoarthritis
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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Behavioral: Tai Chi
    12 weeks of Tai Chi
  • Behavioral: Physical Therapy
    6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
  • Active Comparator: Tai Chi
    12 weeks of Tai Chi classes
    Intervention: Behavioral: Tai Chi
  • Active Comparator: Physical Therapy
    6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
    Intervention: Behavioral: Physical Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
180
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01258985
1R01AT005521-01A1( U.S. NIH Grant/Contract )
R01AT005521 ( U.S. NIH Grant/Contract )
UL1TR000073 ( U.S. NIH Grant/Contract )
UL1TR001064 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: De-identified participant data will be made available upon request.
Tufts Medical Center
Tufts Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Chenchen Wang, MD, MSc Tufts Medical Center
Tufts Medical Center
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP