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Tai Chi and Physical Therapy for Knee Osteoarthritis (TCPT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01258985
First received: December 10, 2010
Last updated: December 9, 2013
Last verified: December 2013
  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: Week 0, Week 12 ] [ Designated as safety issue: No ]
    Pain


Secondary Outcome Measures:
  • Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale at follow-up [ Time Frame: Week 0, Week 24, Week 52 ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  • Medical Outcomes Short Form-36 [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Quality of Life

  • PROMIS Physical Functioning Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    physical function

  • 6 Minute Walk [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Walking ability and endurance

  • 20 Meter Walk [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    walking ability

  • Chair Stand Test [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Lower extremity physical function

  • Berg Balance Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Balance

  • Qualitative Gait Analysis [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Video-taped gait analysis

  • Postural Sway [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Balance and postural sway

  • Muscle Strength and Leg Power [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    muscle strength and power

  • Beck II Depression Inventory [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Depression

  • Perceived Stress Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Stress

  • PROMIS Pain Impact Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Pain

  • PROMIS Distress-Depression Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Depression

  • PROMIS Distress-Anxiety Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Anxiety

  • PROMIS Sleep Disturbance Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Sleep quality

  • PROMIS Social Roles Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Social Roles and Satisfaction

  • Arthritis Self-Efficacy Scale function subscale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Self-efficacy

  • Medical Outcome Study Social Support Survey [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Social Support

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function and stiffness [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    physical function and stiffness

  • PROMIS Health Assessment Questionnaire [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Health Status

  • Health Assessment Questionnaire Utilization [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Healthcare cost and utilization

  • Outcome Expectation Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Participant expectations

  • Champs Activity Questionnaire for Older Adults [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Physical Activity Levels


Estimated Enrollment: 180
Study Start Date: March 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (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
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
Investigators
Principal Investigator: Chenchen Wang, MD, MSc Tufts Medical Center
  More Information

Publications:
Additional 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
Study First Received: December 10, 2010
Last Updated: December 9, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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 November 23, 2014