Iyengar Yoga for Young People With Rheumatoid Arthritis

NCT ID: NCT01096823

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-05-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Iyengar Yoga

Group Type: EXPERIMENTAL

Iyengar Yoga

Intervention Type: BEHAVIORAL

Iyengar Yoga classes twice a week for six weeks

Waitlist Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Iyengar Yoga

Iyengar Yoga classes twice a week for six weeks

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Lonnie Zeltzer

Distinguished Professor of Pediatrics, Anesthesiology, Psychiatry and Biobehavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lonnie K Zeltzer, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Pediatric Pain Program Research Offices

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21255431 (View on PubMed)

Other Identifiers

R21AR057318-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link