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Iyengar Yoga for Young People With Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01096823
First received: March 24, 2010
Last updated: March 30, 2010
Last verified: March 2010
History of Changes
  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.

Condition Intervention
Rheumatoid Arthritis
 Behavioral: Iyengar Yoga

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

Resource links provided by NLM:

U.S. FDA Resources

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: baseline (within 2 weeks of receiving intervention) and post intervention (within 2 weeks of completing intervention; 2 month follow-up ] [ Designated as safety issue: No ]
    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.

  • Pain Disability Index (PDI) [ Time Frame: baseline (within 2 weeks of receiving intervention) and post intervention (within 2 weeks of completing intervention; 2 month follow-up ] [ Designated as safety issue: No ]
    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.

  • Health Assessment Questionnaire (HAQ) [ Time Frame: baseline (within 2 weeks of receiving intervention) and post intervention (within 2 weeks of completing intervention; 2 month follow-up ] [ Designated as safety issue: No ]
    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

  • Disease Activity Scale (DAS)28 [ Time Frame: baseline (within 2 weeks of receiving intervention) and post intervention (within 2 weeks of completing intervention; 2 month follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: June 2009
Estimated Study Completion Date: May 2011
Estimated 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

  Eligibility

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096823

Contacts
Contact: Laura A Cousins, B.A. 310 500 8681 lcousins@mednet.ucla.edu

Locations
United States, California
UCLA Pediatric Pain Program Research Offices Recruiting
Los Angeles, California, United States, 90064
Contact: Lonnie K Zeltzer, M.D.     310-825-0731     LZeltzer@mednet.ucla.edu    
Principal Investigator: Lonnie K Zeltzer, M.D.            
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Lonnie K Zeltzer, M.D. University of California, Los Angeles
  More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Lonnie K. Zeltzer, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01096823     History of Changes
Other Study ID Numbers: R21AR057318-01
Study First Received: March 24, 2010
Last Updated: March 30, 2010
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013