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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00362453 |
The purpose of this study is to compare the safety and effectiveness of Tai Chi with a stretching and wellness education program in 40 patients with OA of the knee.
Condition | Intervention |
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Knee Osteoarthritis |
Behavioral: 12-week tai Chi program Behavioral: 12-week stretching and wellness education program |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Tai Chi Mind-Body Therapy for Knee Osteoarthritis: a Pilot Single-Blind Randomized Controlled Trial |
Estimated Enrollment: | 40 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | March 2008 |
Osteoarthritis (OA) is the most common form of arthritis in the United States, affecting 21 million older people.
Symptomatic knee OA in the elderly is one of the most frequent causes of loss of independence and physical disability. There are currently no satisfactory pharmacological or non-pharmacological therapies for knee OA. New strategies to improve functional capacity, quality of life and reduce long-term disability in people with knee OA are urgently needed. Our long-term goal is to demonstrate the physical and psychological benefits of Tai Chi exercise as a complementary treatment for people with knee OA. Tai Chi is a traditional Chinese discipline with both physical and mental components that appear to benefit a variety of conditions. The physical component provides exercise that is consistent with recommendations for OA (range of motion, flexibility, muscle conditioning and aerobic cardiovascular exercise), while the mental component has the potential to increase psychological well-being, life satisfaction, and perceptions of health. These effects are especially pertinent for the treatment of older adults with knee OA.
Over a three-year period, 40 patients with symptomatic knee OA will be randomly assigned to receive a 12-week Tai Chi program or stretching and wellness education program. Each participant will be in the study for 1 year. Outcome measurements will be obtained at baseline and on completion of the 12-week program, as well as 3 month and 6 month follow-up period. We will compare changes in knee pain, stiffness, and physical function using the well-validated Western Ontario and McMaster University Index, as well as clinical knee examination, lower extremity functional, knee joint proprioception, and health related quality of life.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
· Age 55 or older
Radiographic evidence of knee OA, defined as the presence of Osteophytes in the tibiofemoral compartment and
Exclusion Criteria:
United States, Massachusetts | |
Tufts-New England Medical Center, Division of Rheumatology | |
Boston, Massachusetts, United States, 02111 |
Principal Investigator: | Chenchen Wang, MD | Tufts Medical Center |
Study ID Numbers: | R21 AT002161 |
Study First Received: | August 9, 2006 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00362453 History of Changes |
Health Authority: | United States: Federal Government |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |