Comparing Tai Chi Chih and Relaxation Therapy in the Treatment of Rheumatoid Arthritis
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tai Chi Chih
Relaxation training
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Arthritis, Tai Chi, Meditation, Relaxation Techniques
Eligibility Criteria
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
Sites / Locations
- Cedars-Sinai Medical Center
- University of California, Los Angeles Medical Center
Outcomes
Primary Outcome Measures
RA-related disability
Health functioning
Secondary Outcome Measures
Full Information
NCT ID
NCT00096759
First Posted
November 15, 2004
Last Updated
March 21, 2013
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00096759
Brief Title
Comparing Tai Chi Chih and Relaxation Therapy in the Treatment of Rheumatoid Arthritis
Official Title
Efficacy of CAM Interventions in Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Arthritis, Tai Chi, Meditation, Relaxation Techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi Chih
Intervention Type
Behavioral
Intervention Name(s)
Relaxation training
Primary Outcome Measure Information:
Title
RA-related disability
Title
Health functioning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Pike, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Tai Chi Chih and Relaxation Therapy in the Treatment of Rheumatoid Arthritis
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