Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments tai chi, physical therapy
Sponsor Tufts Medical Center
Collaborator National Center for Complementary and Alternative Medicine (NCCAM)
Start date March 2011
End date December 2013
Trial size 180 participants
Trial identifier NCT01258985, 1R01AT005521-01A1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
12 weeks of Tai Chi classes
tai chi
12 weeks of Tai Chi
(Active Comparator)
6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
physical therapy
6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Primary Outcomes

Measure
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale from baseline to 12 Weeks
time frame: Week 0, Week 12

Secondary Outcomes

Measure
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
PROMIS Physical Functioning Short Form
time frame: Week 0, Week 12, Week 24, Week 52
6 Minute Walk
time frame: Week 0, Week 12, Week 24, Week 52
20 Meter Walk
time frame: Week 0, Week 12, Week 24, Week 52
Chair Stand Test
time frame: Week 0, Week 12, Week 24, Week 52
Berg Balance Scale
time frame: Week 0, Week 12, Week 24, Week 52
Qualitative Gait Analysis
time frame: Week 0, Week 12, Week 24, Week 52
Postural Sway
time frame: Week 0, Week 12, Week 24, Week 52
Muscle Strength and Leg Power
time frame: Week 0, Week 12, Week 24, Week 52
Beck II Depression Inventory
time frame: Week 0, Week 12, Week 24, Week 52
Perceived Stress Scale
time frame: Week 0, Week 12, Week 24, Week 52
PROMIS Pain Impact Short Form
time frame: Week 0, Week 12, Week 24, Week 52
PROMIS Distress-Depression Short Form
time frame: Week 0, Week 12, Week 24, Week 52
PROMIS Distress-Anxiety Short Form
time frame: Week 0, Week 12, Week 24, Week 52
PROMIS Sleep Disturbance Short Form
time frame: Week 0, Week 12, Week 24, Week 52
PROMIS Social Roles Short Form
time frame: Week 0, Week 12, Week 24, Week 52
Arthritis Self-Efficacy Scale function subscale
time frame: Week 0, Week 12, Week 24, Week 52
Medical Outcome Study Social Support Survey
time frame: Week 0, Week 12, Week 24, Week 52
Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function and stiffness
time frame: Week 0, Week 12, Week 24, Week 52
PROMIS Health Assessment Questionnaire
time frame: Week 0, Week 12, Week 24, Week 52
Health Assessment Questionnaire Utilization
time frame: Week 0, Week 12, Week 24, Week 52
Outcome Expectation Scale
time frame: Week 0, Week 12, Week 24, Week 52
Champs Activity Questionnaire for Older Adults
time frame: Week 0, Week 12, Week 24, Week 52

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Tai Chi and Physical Therapy for Knee Osteoarthritis
Principal investigator Chenchen Wang, MD, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Tufts Medical Center.