Tai Chi Mind-Body Therapy for Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00362453
First received: August 9, 2006
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Behavioral: Tai Chi versus Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tai Chi Mind-Body Therapy for Knee Osteoarthritis: a Pilot Single-blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks [ Time Frame: between baseline and 12 weeks. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. [ Time Frame: from baseline to 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. [ Time Frame: baseline to 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks. [ Time Frame: baseline to 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) [ Time Frame: baseline to 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. [ Time Frame: baseline to 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. [ Time Frame: baseline to 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. [ Time Frame: baseline to 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. [ Time Frame: baseline to 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. [ Time Frame: baseline to 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. [ Time Frame: baseline to 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. [ Time Frame: baseline, 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component [ Time Frame: baseline to 12, 24, 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: August 2005
Study Completion Date: June 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Tai Chi versus Attention Control
60 minutes, twice a week for 12 weeks.
Other Name: Yang style Tai Chi
Placebo Comparator: 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.
Behavioral: Tai Chi versus Attention Control
60 minutes, twice a week for 12 weeks.
Other Name: Yang style Tai Chi

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00362453

Locations
United States, Massachusetts
Tufts Medical Center, Division of Rheumatology
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Chenchen Wang, MD, MSc Tufts Medical Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chenchen Wang, MD, MSc, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00362453     History of Changes
Other Study ID Numbers: R21 AT002161, R21AT002161
Study First Received: August 9, 2006
Results First Received: September 25, 2009
Last Updated: February 10, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014