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Iyengar Yoga for Young People With Rheumatoid Arthritis

This study has been completed.
Information provided by (Responsible Party):
Lonnie Zeltzer, University of California, Los Angeles Identifier:
First received: March 24, 2010
Last updated: March 24, 2016
Last verified: March 2016

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.

Condition Intervention
Rheumatoid Arthritis
Behavioral: Iyengar Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iyengar Yoga for Young People With Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Health Related Quality of Life - Short Form-36 (SF-36) [ Time Frame: post intervention (within 2 weeks of completing intervention) ]

    The Health Related Quality of Life - Short Form-36 (SF-36) is a generic core HRQOL measure yielding an 8-scale profile of functional health and well being. The SF-36 performs comparatively better than other HRQOL measures in terms of reliability, validity, lightness of respondent/administrative burden. It can be completed in 5-10 minutes and has been used with children as young as 10 years of age.

    Subscales - all ranges 0-100 with higher scores indicating increased quality of life Bodily Pain, 2 items General Health, 5 items Vitality, 4 items Mental Health, 5 items

  • Pain Disability Index (PDI) [ Time Frame: post intervention (within 2 weeks of completing intervention) ]

    The PDI assess the impact of pain on ability to participate in basic life activities, including social activity, sexual behavior, self-care and life-support activity. The PDI has been used with patients as young as 15. Good internal reliability (α = .82) and validity have been reported. It takes less than 5 minutes to complete.

    7 items, total measure range: 0-70, higher scores = higher interference/disability

  • Health Assessment Questionnaire (HAQ) [ Time Frame: post intervention (within 2 weeks of completing intervention) ]

    Items include questions about dressing and grooming, rising, eating, walking, hygiene, reaching, grip and making activities. The HAQ is one of the most widely recognized measures of patient functioning, with acceptable reliability and validity. It has been used successfully with adolescents as young as 13 years of age

    Range: 0-100, lower scores indicate better health

  • Disease Activity Scale (DAS)28 [ Time Frame: post intervention (within 2 weeks of completing intervention) ]

    is a combined index that measures disease activity in patients with RA and remains a more thorough, established alternative to standard medical exams. This index includes a 28 tender joint count, 28 swollen joint count, Erythrocyte Sedimentation Rate (ESR), and general health assessment using a visual analogue scale. The ESR indirectly measures inflammation in the body and involves collecting blood samples, which will be performed by a qualified phlebotomist.

    The DAS score is a complicated formula based on many factors so there are no set ranges, but the published standards are as follows:

    "A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6." Source: Available at Accessed February 5, 2009.

Enrollment: 30
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iyengar Yoga Behavioral: Iyengar Yoga
Iyengar Yoga classes twice a week for six weeks
No Intervention: Waitlist Control


Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01096823

United States, California
UCLA Pediatric Pain Program Research Offices
Los Angeles, California, United States, 90064
Sponsors and Collaborators
University of California, Los Angeles
Principal Investigator: Lonnie K Zeltzer, M.D. University of California, Los Angeles
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lonnie Zeltzer, Distinguished Professor of Pediatrics, Anesthesiology, Psychiatry and Biobehavioral Sciences, University of California, Los Angeles Identifier: NCT01096823     History of Changes
Other Study ID Numbers: R21AR057318-01 ( US NIH Grant/Contract Award Number )
Study First Received: March 24, 2010
Results First Received: February 11, 2016
Last Updated: March 24, 2016

Keywords provided by University of California, Los Angeles:
Rheumatoid Arthritis
Young Adults

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on May 24, 2017