Los Angeles, California 90064

  • Rheumatoid Arthritis

Purpose:

The purpose of this study is to compare a standardized 6 week Iyengar Yoga program (IYP) for adolescents and young adults with rheumatoid arthritis to a standard care wait-list condition. In addition to effects on function and pain, this study will explore intervention effects on disease activity, immune response, HRQOL, functionality, and mood. Results will shed light on the feasibility and potential efficacy of a novel intervention (Iyengar yoga) for rheumatoid arthritis symptoms. The hypotheses are: 1. The IYP will be safe, acceptable and feasible: at least 80% of subjects will complete the IYP. 2. Following the IYP, participants will show significantly improved disease status, general functioning, arthritis-functioning and HRQOL relative to controls. The benefits will be apparent post-treatment and at two-month follow-up. 3. Following the IYP, participants will report significantly improved pain, immune response and mood compared to controls. These improvements will be evident at both post-treatment and at two-month follow-up.


Criteria:

Inclusion Criteria: - People with rheumatoid arthritis between the ages of 16-35 - Diagnosis of RA, according to the revised 1987 ACR criteria, or juvenile idiopathic arthritis (JIA) for at least 6 months - Concomitant use of disease modifying antirheumatic medications (hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etc) biologic agents (infliximab, etanercept, adalimumab, abatacept, rituximab, anakinra) is permitted provided that the dose(s) have been stable for 4 weeks prior to screening, and may reasonably be expected to remain on stable doses throughout the duration of the trial - Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) and low dose corticosteroids (e.g prednisone at doses of 10 /day prednisone or equivalent is permitted provided that the dose(s) have been stable for 4 weeks prior to screening, and may reasonably be expected to remain on stable doses throughout the duration of the trial - Disease activity, as defined using a 28 joint count by > 5 tender joints, > 5 swollen joints, and one of the following: ESR > 28 mm/hour, CRP > 1.5 mg/dL, duration of a.m. stiffness > 45 minutes - Ability to provide written informed consent - Ability to speak and understand English Exclusion Criteria: - Intra-articular steroid injections within 4 weeks of screening - Treatment with any investigational agent within 8 weeks of screening or 5 half-lives of the investigational drug (whichever is longer) - History of drug, alcohol, or chemical abuse within 6 months prior to screening - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion that might affect the interpretation of the results or render the patient at high risk from treatment complications - Inability to comply with study and follow-up procedures - Currently pregnant - Inability to speak or understand English - Any recent injury.


NCT ID:

NCT01096823


Primary Contact:

Principal Investigator
Lonnie K Zeltzer, M.D.
University of California, Los Angeles

Laura A Cousins, B.A.
Phone: 310 500 8681
Email: lcousins@mednet.ucla.edu


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90064
United States

Lonnie K Zeltzer, M.D.
Phone: 310-825-0731
Email: LZeltzer@mednet.ucla.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.