Iyengar Yoga for Young People With Rheumatoid Arthritis

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Behavioral: Iyengar Yoga

Study type: Interventional

Funder types: Other

Identifiers

NCT01096823

R21AR057318-01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Iyengar Yoga

Experimental group

Treatment:

Behavioral: Iyengar Yoga

Waitlist Control

No Intervention group