Iyengar Yoga for Young People With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Iyengar Yoga for Young People With Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01096823
• Other study ID #: R21AR057318-01
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2010
• Last updated: March 30, 2010
• Start date: June 2009
• Est. completion date: May 2011

Study information

• Verified date: March 2010
• Source: University of California, Los Angeles
• Contact: Laura A Cousins, B.A.
• Phone: 310 500 8681
• Email: lcousins[@]mednet.ucla.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Iyengar Yoga
Iyengar Yoga classes twice a week for six weeks

Locations

Country	Name	City	State
United States	UCLA Pediatric Pain Program Research Offices	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (within 2 weeks of receiving intervention) and post intervention (within 2 weeks of completing intervention; 2 month follow-up	No
Primary	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 (a = .82) and validity have been reported. It takes less than 5 minutes to complete.	baseline (within 2 weeks of receiving intervention) and post intervention (within 2 weeks of completing intervention; 2 month follow-up	No
Primary	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	baseline (within 2 weeks of receiving intervention) and post intervention (within 2 weeks of completing intervention; 2 month follow-up	No
Primary	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.	baseline (within 2 weeks of receiving intervention) and post intervention (within 2 weeks of completing intervention; 2 month follow-up	No