Clinical trial NCT01096823: Iyengar Yoga for Young People With Rheumatoid Arthritis
Official title: Iyengar Yoga for Young People With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Yoga
Adolescents
Young Adults
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Health Related Quality of Life - Short Form-36 (SF-36)
timeFrame: post intervention (within 2 weeks of completing intervention)
measure: Pain Disability Index (PDI)
timeFrame: post intervention (within 2 weeks of completing intervention)
measure: Health Assessment Questionnaire (HAQ)
timeFrame: post intervention (within 2 weeks of completing intervention)
measure: Disease Activity Scale (DAS)28
timeFrame: post intervention (within 2 weeks of completing intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Pediatric Pain Program Research Offices
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Lonnie K Zeltzer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.