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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT002971-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This study is designed to examine the impact of hatha yoga on immune and hormonal functioning in healthy individuals.
This study is designed to examine the effects of hatha yoga on autonomic, immune, and endocrine function. The data from both inexperienced and experienced groups will help us better understand how longer-term practice of yoga may be beneficial. The study consists of one 3-hour screening session and three 6-hour activity sessions with 30 minute follow-up appointments the following morning scheduled 2 - 4 weeks apart. Each participant will complete the 3 activity sessions, which will consist of either yoga, mild movement, or a neutral activity (watching a videotape), in randomly assigned order. Thus, both novices and experts will participate in 3 activity sessions each (yoga, movement control, video control). The order in which each participant goes through the activity sessions is counterbalanced. Data for each activity session will be aggregated by group (i.e. novice or expert). We will measure responses to tape stripping to assess skin barrier repair, and evaluate responses to computer tasks, self-report measures, and a battery of unobtrusive behavioral measures. We will also collect blood and saliva samples to measure immune and endocrine outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hatha yoga classes | Experimental | Groups consisted of novices or experts. Groups were counterbalanced to ensure that equal number of novices and experts participated in each possible session combination, in a randomly assigned order. |
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| Movement Control | Sham Comparator | Non-Hatha yoga gentle movement. Groups consisted of novices or experts. Groups were counterbalanced to ensure that equal number of novices and experts participated in each possible session combination, in a randomly assigned order. |
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| Passive Video Control | No Intervention | Another control condition, a neutral video that did not include any music, allowed us to contrast the effects of yoga with no activity.The session included a sequence on how to design physics experiments for a high school classroom, as well as segments from two lectures on polymers and quantum mechanics. Groups were counterbalanced to ensure that equal number of novices and experts participated in each possible session combination, in a randomly assigned order. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hatha Yoga Classes | Behavioral | Iyengar yoga, the form of hatha yoga used in this study, emphasizes the use of props to help students achieve precise postures safely and comfortably according to their particular body types and needs. The yoga activity sessions were directed by four experienced yoga teachers following a script. The poses used were (in order) Supta Baddha Konasana (Reclining Bound Angle Pose), Adho Mukha Svanasana (Downward Facing Dog), Supported Uttanasana (Intense Forward Stretch), Parsvotanasana (Intense Side Stretch Pose), Prasarita Padottanansana (Wide-Legged Forward Bend), Janu Sirsasana (Head to Knee Pose), Bharadvajasana (Simple Seated Twist Pose), Viparita Karani (Restful Inversion), Supported Setu Bandha Sarvanagasana (Bridge Pose), and Savasana (Corpse Pose). Blood draws occurred during the last two minutes of Supta Baddha Konasana (pose held 10 minutes), Viparita Karani (10 minutes), and Savasana (15 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Detectable C-Reactive Protein (CRP) | 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. | 8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart |
| Cortisol | All 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. | Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30 |
| Skin Barrier Repair: Trans-epidermal Water Loss (TEWL) | Cellophane 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. | 11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart |
| Immune Function: Soluble Interleukin-6 Receptor (sIL-6r) | Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions. | Day 1 8:30, 11:35, 13:10. Day 2 7:30 |
| Immune Function: Tumor Necrosis Factor-alpha (TNF-α) | Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15 | |
| Blood Pressure | 7:55 at each of the three visits, scheduled at least 2 weeks apart | |
| Mood: Positive and Negative Affect Schedule (PANAS)Positive |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice K. Kiecolt-Glaser, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Clinical Research Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20064902 | Result | Kiecolt-Glaser JK, Christian L, Preston H, Houts CR, Malarkey WB, Emery CF, Glaser R. Stress, inflammation, and yoga practice. Psychosom Med. 2010 Feb;72(2):113-21. doi: 10.1097/PSY.0b013e3181cb9377. Epub 2010 Jan 11. |
| Label | URL |
|---|---|
| Please click here to visit our website if you would like to read more about our studies. | View source |
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Women were recruited through online ads and notices posted in yoga studios. All women participated in some form of hatha yoga.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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.
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| FG001 | 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.
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| FG002 | 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.
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| FG003 | 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.
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| FG004 | 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.
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| FG005 | 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.
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| FG006 | 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.
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| FG007 | 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.
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| FG008 | 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.
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| FG009 | 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.
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| FG010 | 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.
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| FG011 | 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.
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Session 1 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Detectable C-Reactive Protein (CRP) | 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. | Posted | Number | participants with CRP above 0.3 | 8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart |
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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 | Novice | Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janice Kiecolt-Glaser, PhD | Ohio State University Institute for Behavioral Medicine Research | 614-292-0033 | Kiecolt-Glaser.1@osu.edu |
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| Movement Control | Behavioral | Walking on a treadmill at .5 miles per hour was used to control for general physical movement/cardiovascular expenditure because it best approximated the heart rates during the restorative yoga session. To match the lower heart rate, women also rested supine on a bed for several minutes after walking, before and after getting their blood drawn. |
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| Day 1 8:30, 11:35, 13:10. Day 2 7:30 |
| Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6) | Supernatants 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). | Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30 |
| Immune Function: LPS-stimulated Production of TNF-α | Supernatants 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). | Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30 |
| Immune Function: Interleukin-6 (IL-6) | Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions | Day 1 8:30, 11:35, 13:10. Day 2 7:30 |
| Catecholamine Production: Epinephrine | All 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. | 8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart |
| Catecholamine Production: Norepinephrine | All 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. | 8:30, 10:05, 10:28, 10:58, 11:35, 12:05 |
The 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. |
| 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart |
| Mood: Positive and Negative Affect Schedule (PANAS)Negative | The 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. | 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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.
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| Primary | Cortisol | All 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. | Not Posted | Mean | Standard Error | pg/ml | Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30 |
| Primary | Skin Barrier Repair: Trans-epidermal Water Loss (TEWL) | Cellophane 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. | Not Posted | Mean | Standard Deviation | number tape strips | 11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart |
| Primary | Immune Function: Soluble Interleukin-6 Receptor (sIL-6r) | Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions. | Not Posted | Mean | Standard Deviation | pg/ml | Day 1 8:30, 11:35, 13:10. Day 2 7:30 |
| Primary | Immune Function: Tumor Necrosis Factor-alpha (TNF-α) | Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions. | Not Posted | Mean | Standard Deviation | pg/ml (log 10) | Day 1 8:30, 11:35, 13:10. Day 2 7:30 |
| Primary | Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6) | Supernatants 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). | Not Posted | Mean | Standard Deviation | pg/ml | Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30 |
| Primary | Immune Function: LPS-stimulated Production of TNF-α | Supernatants 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). | Not Posted | Mean | Standard Deviation | pg/ml | Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30 |
| Primary | Immune Function: Interleukin-6 (IL-6) | Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions | Not Posted | Mean | Standard Deviation | pg/ml (log 10) | Day 1 8:30, 11:35, 13:10. Day 2 7:30 |
| Primary | Catecholamine Production: Epinephrine | All 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. | Not Posted | Mean | Standard Deviation | pg/ml (log 10) | 8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart |
| Primary | Catecholamine Production: Norepinephrine | All 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. | Not Posted | Mean | Standard Deviation | pg/ml (log 10) | 8:30, 10:05, 10:28, 10:58, 11:35, 12:05 |
| Secondary | Heart Rate | Not Posted | Mean | Standard Deviation | bpm | Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15 |
| Secondary | Blood Pressure | Not Posted | Mean | Standard Deviation | mmHg | 7:55 at each of the three visits, scheduled at least 2 weeks apart |
| Secondary | Mood: Positive and Negative Affect Schedule (PANAS)Positive | The 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. | Not Posted | Mean | Standard Deviation | Cumulative Score, 0-50 | 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart |
| Secondary | Mood: Positive and Negative Affect Schedule (PANAS)Negative | The 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. | Not Posted | Number | Cumulative Score, 0-50 | 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Expert | 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. | 0 | 26 | 0 | 26 |
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