Iyengar Yoga for Young People With Rheumatoid Arthritis
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable rheumatoid-arthritis
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
April 27, 2016
CompletedApril 27, 2016
March 1, 2016
1.9 years
March 24, 2010
February 11, 2016
March 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Health Related Quality of Life - Short Form-36 (SF-36)
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
post intervention (within 2 weeks of completing intervention)
Pain Disability Index (PDI)
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
post intervention (within 2 weeks of completing intervention)
Health Assessment Questionnaire (HAQ)
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
post intervention (within 2 weeks of completing intervention)
Disease Activity Scale (DAS)28
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: DAS-Score.nl. Available at http://www.das-score.nl/www.das-score.nl/index.html. Accessed February 5, 2009.
post intervention (within 2 weeks of completing intervention)
Study Arms (2)
Iyengar Yoga
EXPERIMENTALWaitlist Control
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA Pediatric Pain Program Research Offices
Los Angeles, California, 90064, United States
Related Publications (1)
Evans S, Cousins L, Tsao JC, Subramanian S, Sternlieb B, Zeltzer LK. A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol. Trials. 2011 Jan 21;12:19. doi: 10.1186/1745-6215-12-19.
PMID: 21255431DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Lonnie K. Zeltzer, MD
- Organization
- Pediatric Pain and Palliative Care Program; University of California, Los Angeles
Study Officials
- PRINCIPAL INVESTIGATOR
Lonnie K Zeltzer, M.D.
University of California, Los Angeles
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor of Pediatrics, Anesthesiology, Psychiatry and Biobehavioral Sciences
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 31, 2010
Study Start
June 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
April 27, 2016
Results First Posted
April 27, 2016
Record last verified: 2016-03