Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Yoga, Adolescents, Young Adults
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.
Interventions
BEHAVIORALIyengar Yoga
Iyengar Yoga classes twice a week for six weeks
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life - Short Form-36 (SF-36) | post intervention (within 2 weeks of completing intervention) | 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) | post intervention (within 2 weeks of completing intervention) | 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) | post intervention (within 2 weeks of completing intervention) | 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 | post intervention (within 2 weeks of completing intervention) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iyengar Yoga Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks | 11 |
| Waitlist Control Standard of care waitlist control group | 15 |
| Total | 26 |
Baseline characteristics
| Characteristic | Iyengar Yoga | Waitlist Control | Total |
|---|---|---|---|
| Age, Continuous | 29.9 years STANDARD_DEVIATION 2.9 | 27.1 years STANDARD_DEVIATION 4.2 | 28.3 years STANDARD_DEVIATION 3.9 |
| Sex: Female, Male Female | 11 Participants | 15 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 15 |
| serious Total, serious adverse events | 0 / 11 | 0 / 15 |
Outcome results
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. 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.
Time frame: post intervention (within 2 weeks of completing intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iyengar Yoga | Disease Activity Scale (DAS)28 | 3.3 units on a scale | Standard Deviation 1.2 |
| Waitlist Control | Disease Activity Scale (DAS)28 | 3.3 units on a scale | Standard Deviation 1.6 |
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 Range: 0-100, lower scores indicate better health
Time frame: post intervention (within 2 weeks of completing intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iyengar Yoga | Health Assessment Questionnaire (HAQ) | 31.5 units on a scale | Standard Deviation 28.5 |
| Waitlist Control | Health Assessment Questionnaire (HAQ) | 55.9 units on a scale | Standard Deviation 31.5 |
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. 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
Time frame: post intervention (within 2 weeks of completing intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iyengar Yoga | Health Related Quality of Life - Short Form-36 (SF-36) | Bodily Pain Sub-Scale | 59.1 units on a scale | Standard Deviation 19.2 |
| Iyengar Yoga | Health Related Quality of Life - Short Form-36 (SF-36) | General Health Sub-Scale | 60.1 units on a scale | Standard Deviation 21.4 |
| Iyengar Yoga | Health Related Quality of Life - Short Form-36 (SF-36) | Vitality Sub-Scale | 64.5 units on a scale | Standard Deviation 12.3 |
| Iyengar Yoga | Health Related Quality of Life - Short Form-36 (SF-36) | Mental Health Sub-Scale | 81.6 units on a scale | Standard Deviation 6.9 |
| Waitlist Control | Health Related Quality of Life - Short Form-36 (SF-36) | Mental Health Sub-Scale | 67.8 units on a scale | Standard Deviation 19.5 |
| Waitlist Control | Health Related Quality of Life - Short Form-36 (SF-36) | Bodily Pain Sub-Scale | 59.3 units on a scale | Standard Deviation 26.4 |
| Waitlist Control | Health Related Quality of Life - Short Form-36 (SF-36) | Vitality Sub-Scale | 37.7 units on a scale | Standard Deviation 21.7 |
| Waitlist Control | Health Related Quality of Life - Short Form-36 (SF-36) | General Health Sub-Scale | 47.0 units on a scale | Standard Deviation 16.7 |
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 (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
Time frame: post intervention (within 2 weeks of completing intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iyengar Yoga | Pain Disability Index (PDI) | 13.5 units on a scale | Standard Deviation 14.5 |
| Waitlist Control | Pain Disability Index (PDI) | 15.4 units on a scale | Standard Deviation 17.3 |