Tai Chi Mind-Body Therapy for Knee Osteoarthritis

NCT00362453 | Completed Results DMC

• 1 other identifier: R21AT002161
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks

  WOMAC scale range: 0 millimeters (no pain) to 500 millimeters (severe pain), ordinal. Change: score at 12 weeks minus score at baseline. Negative numbers reported here indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)

  between baseline and 12 weeks.

Secondary Outcomes (12)

• Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks.

  from baseline to 12, 24, 48 weeks

• Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks.

  baseline to 12, 24, 48 weeks

• Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks.

  baseline to 24, 48 weeks

• Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS)

  baseline to 12, 24, 48 weeks

• Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks.

  baseline to 12, 24, 48 weeks

Study Arms (2)

Tai Chi

EXPERIMENTAL

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.

Behavioral: Tai Chi versus Attention Control

Wellness Education and Stretching

PLACEBO COMPARATOR

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.

Behavioral: Tai Chi versus Attention Control

Interventions

Tai Chi versus Attention Control BEHAVIORAL

60 minutes, twice a week for 12 weeks.

Also known as: Yang style Tai Chi

Tai Chi; Wellness Education and Stretching

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Tufts Medical Center, Division of Rheumatology

Boston, Massachusetts, 02111, United States

Location

Related Publications (4)

• 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.

  PMID: 15006825 BACKGROUND

• 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.

  PMID: 15741197 BACKGROUND

• 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.

  PMID: 19877092 DERIVED

• 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.

  PMID: 18664276 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

small sample size

Results Point of Contact

• Title: Chenchen Wang, MD, MSc, Associate Professor
• Organization: Tufts Medical Center

cwang2@tuftsmedicalcenter.org

617-636-3251

Study Officials

• Chenchen Wang, MD, MSc

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 10, 2006
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2009
• Last Updated: April 23, 2019
• Results First Posted: February 8, 2010

Record last verified: 2019-04

Locations

US (1)