Trial Outcomes & Findings for Iyengar Yoga for Young People With Rheumatoid Arthritis (NCT NCT01096823)
NCT ID: NCT01096823
Last Updated: 2016-04-27
Results Overview
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
COMPLETED
NA
30 participants
post intervention (within 2 weeks of completing intervention)
2016-04-27
Participant Flow
Participant milestones
| Measure |
Iyengar Yoga
Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
|
Waitlist Control
Standard of care waitlist control group
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Iyengar Yoga for Young People With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Iyengar Yoga
n=11 Participants
Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
|
Waitlist Control
n=15 Participants
Standard of care waitlist control group
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
27.1 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
28.3 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Iyengar Yoga
n=11 Participants
Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
|
Waitlist Control
n=15 Participants
Standard of care waitlist control group
|
|---|---|---|
|
Health Related Quality of Life - Short Form-36 (SF-36)
Bodily Pain Sub-Scale
|
59.1 units on a scale
Standard Deviation 19.2
|
59.3 units on a scale
Standard Deviation 26.4
|
|
Health Related Quality of Life - Short Form-36 (SF-36)
General Health Sub-Scale
|
60.1 units on a scale
Standard Deviation 21.4
|
47.0 units on a scale
Standard Deviation 16.7
|
|
Health Related Quality of Life - Short Form-36 (SF-36)
Vitality Sub-Scale
|
64.5 units on a scale
Standard Deviation 12.3
|
37.7 units on a scale
Standard Deviation 21.7
|
|
Health Related Quality of Life - Short Form-36 (SF-36)
Mental Health Sub-Scale
|
81.6 units on a scale
Standard Deviation 6.9
|
67.8 units on a scale
Standard Deviation 19.5
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Iyengar Yoga
n=11 Participants
Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
|
Waitlist Control
n=15 Participants
Standard of care waitlist control group
|
|---|---|---|
|
Pain Disability Index (PDI)
|
13.5 units on a scale
Standard Deviation 14.5
|
15.4 units on a scale
Standard Deviation 17.3
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Iyengar Yoga
n=11 Participants
Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
|
Waitlist Control
n=15 Participants
Standard of care waitlist control group
|
|---|---|---|
|
Health Assessment Questionnaire (HAQ)
|
31.5 units on a scale
Standard Deviation 28.5
|
55.9 units on a scale
Standard Deviation 31.5
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Iyengar Yoga
n=11 Participants
Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
|
Waitlist Control
n=15 Participants
Standard of care waitlist control group
|
|---|---|---|
|
Disease Activity Scale (DAS)28
|
3.3 units on a scale
Standard Deviation 1.2
|
3.3 units on a scale
Standard Deviation 1.6
|
Adverse Events
Iyengar Yoga
Waitlist Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lonnie K. Zeltzer, MD
Pediatric Pain and Palliative Care Program; University of California, Los Angeles
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place