Iyengar Yoga for Young People With Rheumatoid Arthritis
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:
- The IYP will be safe, acceptable and feasible: at least 80% of subjects will complete the IYP.
- 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.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Iyengar Yoga for Young People With Rheumatoid Arthritis|
- Health Related Quality of Life - Short Form-36 (SF-36) [ Time Frame: post intervention (within 2 weeks of completing intervention) ] [ Designated as safety issue: No ]
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
- Pain Disability Index (PDI) [ Time Frame: post intervention (within 2 weeks of completing intervention) ] [ Designated as safety issue: No ]
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
- Health Assessment Questionnaire (HAQ) [ Time Frame: post intervention (within 2 weeks of completing intervention) ] [ Designated as safety issue: No ]
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
- Disease Activity Scale (DAS)28 [ Time Frame: post intervention (within 2 weeks of completing intervention) ] [ Designated as safety issue: No ]
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.
|Study Start Date:||June 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: Iyengar Yoga||
Behavioral: Iyengar Yoga
Iyengar Yoga classes twice a week for six weeks
|No Intervention: Waitlist Control|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096823
|United States, California|
|UCLA Pediatric Pain Program Research Offices|
|Los Angeles, California, United States, 90064|
|Principal Investigator:||Lonnie K Zeltzer, M.D.||University of California, Los Angeles|