Tai Chi and Physical Therapy for Knee Osteoarthritis (TCPT)

June 23, 2016 updated by: Tufts Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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
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.
From Week 0 to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From Week 0, to Week 12, or to week 24, or to week 52
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.
From Week 0, to Week 12, or to week 24, or to week 52
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
From Week 0, to Week 12, or to week 24, or to week 52
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).
From Week 0, to Week 12, or to week 24, or to week 52
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.
From Week 0, to Week 12, or to week 24, or to week 52
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).
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)
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)
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
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.
From Week 0, to Week 12, or to week 24, or to week 52
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.
Week 0
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.
From Week 0, to week 24 or to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

December 10, 2010

First Posted (Estimate)

December 13, 2010

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

June 23, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 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)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data will be made available upon request.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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