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Comparing Tai Chi Chih and Relaxation Therapy in the Treatment of Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096759
Recruitment Status : Completed
First Posted : November 16, 2004
Last Update Posted : March 22, 2013
Sponsor:
Information provided by (Responsible Party):
National Center for Complementary and Integrative Health (NCCIH)

Tracking Information
First Submitted Date  ICMJE November 15, 2004
First Posted Date  ICMJE November 16, 2004
Last Update Posted Date March 22, 2013
Study Start Date  ICMJE November 2004
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • RA-related disability
  • Health functioning
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Tai Chi Chih and Relaxation Therapy in the Treatment of Rheumatoid Arthritis
Official Title  ICMJE Efficacy of CAM Interventions in Rheumatoid Arthritis
Brief Summary The purpose of this study is to compare the effectiveness of relaxation therapy and tai chi in treating the symptoms of rheumatoid arthritis (RA).
Detailed Description

RA is a debilitating disease characterized by inflammation of the joints, leading to chronic pain, loss of function, and disability. Complementary and alternative medicine (CAM) treatments are being used with increased frequency by patients with chronic pain and rheumatic diseases to relieve their symptoms. While patients find these treatments helpful, there is limited scientific evidence of the effectiveness of these interventions. This study will compare relaxation therapy (a commonly used treatment for RA) to tai chi chih (a combination of slow, deliberate movements and meditation) in treating the symptoms of RA.

Participants will be randomly assigned to receive 12 weeks of either relaxation therapy or tai chi chih. At study entry and Weeks 6 and 12, participants will complete questionnaires about their RA symptoms, health functioning, overall quality of life, and complete a brief medical exam.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Behavioral: Tai Chi Chih
  • Behavioral: Relaxation training
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 23, 2005)
100
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active adult onset rheumatoid arthritis
  • Stable on disease-modifying antirheumatic drugs (DMARDs) or biologic medications
  • Able to walk without use of an assistive device
  • Resides in greater Los Angeles area
  • Willing and able to comply with study requirements

Exclusion Criteria:

  • Uncontrolled or untreated medical conditions
  • Frequent or uncontrolled disease flares
  • Use of certain medications any medical condition deemed by the investigators to interfere with either the patient's safe participation or interpretation of the study data
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00096759
Other Study ID Numbers  ICMJE R21AT002307-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Center for Complementary and Integrative Health (NCCIH)
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer Pike, PhD University of California, Los Angeles
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP