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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iyengar Yoga | Experimental |
| |
| Waitlist Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iyengar Yoga | Behavioral | Iyengar Yoga classes twice a week for six weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | post intervention (within 2 weeks of completing intervention) |
| 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 | post intervention (within 2 weeks of completing intervention) |
| 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 | post intervention (within 2 weeks of completing intervention) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lonnie K Zeltzer, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Pediatric Pain Program Research Offices | Los Angeles | California | 90064 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21255431 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Iyengar Yoga | Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks |
| FG001 | Waitlist Control | Standard of care waitlist control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iyengar Yoga | Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks |
| BG001 | Waitlist Control | Standard of care waitlist control group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | post intervention (within 2 weeks of completing intervention) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iyengar Yoga | Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lonnie K. Zeltzer, MD | Pediatric Pain and Palliative Care Program; University of California, Los Angeles | (310) 825-0731 | LZeltzer@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| post intervention (within 2 weeks of completing intervention) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Waitlist Control |
Standard of care waitlist control group |
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | post intervention (within 2 weeks of completing intervention) |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | post intervention (within 2 weeks of completing intervention) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | post intervention (within 2 weeks of completing intervention) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Waitlist Control | Standard of care waitlist control group | 0 | 15 | 0 | 15 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |