Tai Chi and Physical Therapy for Knee Osteoarthritis (TCPT)

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01258985
First received: December 10, 2010
Last updated: June 23, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Knee Osteoarthritis
Behavioral: Tai Chi
Behavioral: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tai Chi and Physical Therapy for Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Medical Outcomes Short Form-36 PCS [ Time Frame: From Week 0, to Week 12, or to week 24, or to week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 204
Study Start Date: March 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tai Chi
12 weeks of Tai Chi classes
Behavioral: Tai Chi
12 weeks of Tai Chi
Active Comparator: Physical Therapy
6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Behavioral: Physical Therapy
6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

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.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258985

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Chenchen Wang, MD, MSc Tufts Medical Center
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01258985     History of Changes
Other Study ID Numbers: 1R01AT005521-01A1  R01AT005521  UL1TR000073  UL1TR001064 
Study First Received: December 10, 2010
Results First Received: November 4, 2015
Last Updated: June 23, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: De-identified participant data will be made available upon request.

Keywords provided by Tufts Medical Center:
Knee
Knee osteoarthritis
osteoarthritis
Knee pain
Tai Chi
Physical Therapy
mind-body exercise

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 24, 2016