Trial Outcomes & Findings for Yoga, Immune Function, and Health (NCT NCT00371397)
NCT ID: NCT00371397
Last Updated: 2016-07-06
Results Overview
High sensitivity C-reactive protein (hsCRP) assessed once at baseline, at each of the three visits. The hsCRP assay was performed using chemiluminescence methodology with the Immulite 1000 (Siemens Medical Solutions, Los Angeles, Ca.) The lowest level of detection is .3 mg/dL. 43% of the values were below this lower bound, thus hsCRP was dichotomized as undetectable/detectable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart
Results posted on
2016-07-06
Participant Flow
Women were recruited through online ads and notices posted in yoga studios. All women participated in some form of hatha yoga.
Participant milestones
| Measure |
Expert: Movement Control Then Hatha Yoga Then Video
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning.
|
Expert: Hatha Yoga Then Video Then Movement Control
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning.
|
Expert: Video Then Movement Control Then Hatha Yoga
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Hatha Yoga Class in 1 day and a 30 minute follow-up session the next morning.
|
Expert: Movement Control Then Video Then Hatha Yoga
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning.
|
Expert: Hatha Yoga Then Movement Control Then Video
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning.
|
Expert: Video Then Hatha Yoga Then Movement Control
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.
|
Novice: Movement Control Then Hatha Yoga Then Video
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning.
|
Novice: Hatha Yoga Then Video Then Movement Control
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning.
|
Novice: Video Then Movement Control Then Hatha Yoga
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning.
|
Novice: Movement Control Then Video Then Hatha Yoga
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning.
|
Novice: Hatha Yoga Then Movement Control Then Video
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.
* For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
|
Novice: Video Then Hatha Yoga Then Movement Control
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.
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Session 1
STARTED
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Session 1
COMPLETED
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Session 1
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Session 2
STARTED
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Session 2
COMPLETED
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Session 2
NOT COMPLETED
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Session 3
STARTED
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Session 3
COMPLETED
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Session 3
NOT COMPLETED
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Reasons for withdrawal
| Measure |
Expert: Movement Control Then Hatha Yoga Then Video
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning.
|
Expert: Hatha Yoga Then Video Then Movement Control
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning.
|
Expert: Video Then Movement Control Then Hatha Yoga
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Hatha Yoga Class in 1 day and a 30 minute follow-up session the next morning.
|
Expert: Movement Control Then Video Then Hatha Yoga
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning.
|
Expert: Hatha Yoga Then Movement Control Then Video
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning.
|
Expert: Video Then Hatha Yoga Then Movement Control
Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
* For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.
|
Novice: Movement Control Then Hatha Yoga Then Video
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning.
|
Novice: Hatha Yoga Then Video Then Movement Control
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning.
|
Novice: Video Then Movement Control Then Hatha Yoga
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning.
|
Novice: Movement Control Then Video Then Hatha Yoga
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning.
|
Novice: Hatha Yoga Then Movement Control Then Video
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.
* For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
|
Novice: Video Then Hatha Yoga Then Movement Control
Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.
* For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
* For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.
|
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Session 1
Withdrawal by Subject
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1
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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Baseline Characteristics
Yoga, Immune Function, and Health
Baseline characteristics by cohort
| Measure |
Overall Study
n=52 Participants
Women were exposed to each of the conditions (yoga, movement control, and passive-video control) during three separate visits. The order of the visits was randomized per participant. 52 total participants enrolled.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.32 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8:30 a.m. at each of the three visits, scheduled at least 2 weeks apartHigh sensitivity C-reactive protein (hsCRP) assessed once at baseline, at each of the three visits. The hsCRP assay was performed using chemiluminescence methodology with the Immulite 1000 (Siemens Medical Solutions, Los Angeles, Ca.) The lowest level of detection is .3 mg/dL. 43% of the values were below this lower bound, thus hsCRP was dichotomized as undetectable/detectable.
Outcome measures
| Measure |
Novice
n=25 Participants
Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
|
Expert
n=25 Participants
Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
|
|---|---|---|
|
Number of Participants With Detectable C-Reactive Protein (CRP)
|
16 participants with CRP above 0.3
|
8 participants with CRP above 0.3
|
PRIMARY outcome
Timeframe: Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apartCellophane tape stripping, a common dermatological paradigm for studying restoration of the skin barrier, was used to examine whether the time necessary for recovery from minor physical insults varied by condition or yoga expertise. Measurement of the rate of transepidermal water loss (TEWL) through human skin provides a noninvasive method to monitor changes in the skin's barrier function. TEWL was measured twice during the session using a computerized evaporimetry instrument, the DermaLab® (CyberDERM, Media, PA), and barrier recovery was calculated.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 8:30, 11:35, 13:10. Day 2 7:30Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R\&D), per kit instructions.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 8:30, 11:35, 13:10. Day 2 7:30Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R\&D), per kit instructions.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 8:30, 11:35, 13:10. Day 2 7:30Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R\&D), per kit instructions
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apartAll cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8:30, 10:05, 10:28, 10:58, 11:35, 12:05All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7:55 at each of the three visits, scheduled at least 2 weeks apartOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apartThe Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apartThe Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.
Outcome measures
Outcome data not reported
Adverse Events
Novice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Expert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Janice Kiecolt-Glaser, PhD
Ohio State University Institute for Behavioral Medicine Research
Phone: 614-292-0033
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place