Tai Chi Mind-Body Therapy for Knee Osteoarthritis

NCT ID: NCT00362453

Last Updated: 2019-04-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study was to compare the safety and effectiveness of Tai Chi with an Attention Control intervention consisting of a stretching and wellness education program involving 40 patients with osteoarthritis (OA) of the knee. We hypothesized that the participants receiving Tai Chi would show greater improvement in knee pain, physical and psychological functioning, and health-related quality of life than participants in the Attention Control group, and that the benefit would be mediated by effects on muscle function, musculoskeletal flexibility and mental health.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 were randomly assigned to receive a 12-week Tai Chi program or stretching and wellness education program. Outcome measurements were obtained at baseline and on completion of the 12-week program, as well as 24 and 48 week follow-up periods. We compared changes in knee pain, stiffness, and physical function using the well-validated Western Ontario and McMaster Index (WOMAC), as well as clinical knee examination, lower extremity function, knee joint proprioception, and health related quality of life.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tai Chi

The Tai Chi program was based on the classical Yang Style. Patients participated in 60-minute Tai Chi sessions twice a week for 12 weeks. Each session included warm up and review of Tai Chi principles and techniques; Tai Chi exercises; breathing techniques; and various relaxation methods. The classes were taught by a Tai Chi master with over 20 years' experience conducting Tai Chi Mind-Body exercise programs. Several modifications were developed to achieve the physical and mental goals of the study for knee OA, accommodate knee OA symptoms and limit dropouts. Subjects were instructed to practice Tai Chi at least 20 minutes a day at home and encouraged to maintain their usual physical activities, but not to participate in additional new strength training other than their Tai Chi exercises.

Group Type EXPERIMENTAL

Tai Chi versus Attention Control

Intervention Type BEHAVIORAL

60 minutes, twice a week for 12 weeks.

Wellness Education and Stretching

The wellness education and stretching program provided an active control for the attention being paid to the Tai Chi group. The control group attended two 60-minute class sessions per week for 12 weeks. Each session started with 40 minutes of didactic lessons on OA knowledge, nutrition, and physical and mental health education. The final 20 minutes consisted of stretching exercises involving the upper body, trunk and lower body, each stretch being held for 10 to 15 seconds. Participants were also instructed to practice at least 20 minutes of stretching exercises per day at home. They were encouraged to maintain their usual physical activities, but not to participate in additional strength and mind-body exercise programs other than their stretching exercise.

Group Type PLACEBO_COMPARATOR

Tai Chi versus Attention Control

Intervention Type BEHAVIORAL

60 minutes, twice a week for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tai Chi versus Attention Control

60 minutes, twice a week for 12 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Yang style Tai Chi

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 55 or older
* Body Mass Index (BMI) \<= 40 kg/m
* 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 in bed at night
* Radiographic evidence of knee OA, defined as the presence of osteophytes in the tibiofemoral compartment and/or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views
* WOMAC pain subscale score, at least 1 of 5 (range 0 to 100 each) \>= 40 (visual analog version)
* Physically able to participate in both the Tai Chi and stretching and education programs
* Willing to complete the 12-week study, including twice a week Tai Chi or stretching and education sessions
* Willing to abstain from Tai Chi until completion of the program, if randomized to the stretching and education sessions
* Willing to abstain from stretching and education sessions until completion of the program, if randomized to Tai Chi

Exclusion Criteria

* Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine such as Qi gong, yoga, and acupuncture since these share some of the principles of Tai Chi
* Dementia, neurological disease, cardiovascular disease, pulmonary disease, metabolic disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in either the Tai Chi or stretching programs as determined by primary care physicians
* 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)
* Enrollment in any other clinical trial within the last 30 days
* Plan to permanently relocate from the region during the trial period
* Non English Speaking
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Tufts Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chenchen Wang, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tufts Medical Center, Division of Rheumatology

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Wang C, Collet JP, Lau J. The effect of Tai Chi on health outcomes in patients with chronic conditions: a systematic review. Arch Intern Med. 2004 Mar 8;164(5):493-501. doi: 10.1001/archinte.164.5.493.

Reference Type BACKGROUND
PMID: 15006825 (View on PubMed)

Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL. Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford). 2005 May;44(5):685-7. doi: 10.1093/rheumatology/keh572. Epub 2005 Mar 1. No abstract available.

Reference Type BACKGROUND
PMID: 15741197 (View on PubMed)

Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, McAlindon T. Tai Chi is effective in treating knee osteoarthritis: a randomized controlled trial. Arthritis Rheum. 2009 Nov 15;61(11):1545-53. doi: 10.1002/art.24832.

Reference Type DERIVED
PMID: 19877092 (View on PubMed)

Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, Okparavero A, McAlindon T. Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial. BMC Musculoskelet Disord. 2008 Jul 29;9:108. doi: 10.1186/1471-2474-9-108.

Reference Type DERIVED
PMID: 18664276 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21AT002161

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21AT002161

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Acupuncture in Osteoarthritis of the Knee
NCT00325663 COMPLETED PHASE1/PHASE2