Healthy
Conditions
Keywords
yoga, immune function, stress, health, mood, skin barrier repair
Brief summary
This study is designed to examine the impact of hatha yoga on immune and hormonal functioning in healthy individuals.
Detailed description
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.
Interventions
BEHAVIORALHatha Yoga Classes
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).
BEHAVIORALMovement Control
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy female adults * relatively inexperienced with yoga (beginner) * experienced with yoga (advanced practitioner)
Exclusion criteria
* Treatment with medication that has immunological or endocrinological consequences * Chronic health problems that affect immune or endocrine systems * Anemia * Use of psychoactive drugs or mood-altering medication * Smoking * Needle or blood phobias * Tape or bandage allergies * Pregnancy or nursing within the previous 3 months * Heart problems * History of hip or knee replacement surgery, displaced vertebrae, and any other physical limitations that would prevent full participation in the program * use of statins, beta blockers * excessive alcohol use * convulsive disorders * Body Mass Index (BMI) ≥ 30.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catecholamine Production: Norepinephrine | 8:30, 10:05, 10:28, 10:58, 11:35, 12:05 | 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. |
| Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6) | Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30 | 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). |
| Immune Function: LPS-stimulated Production of TNF-α | Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30 | 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). |
| Immune Function: Interleukin-6 (IL-6) | Day 1 8:30, 11:35, 13:10. Day 2 7:30 | Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions |
| Catecholamine Production: Epinephrine | 8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart | 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. |
| Number of Participants With Detectable C-Reactive Protein (CRP) | 8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart | 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. |
| Cortisol | Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30 | 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. |
| Skin Barrier Repair: Trans-epidermal Water Loss (TEWL) | 11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart | 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. |
| Immune Function: Soluble Interleukin-6 Receptor (sIL-6r) | Day 1 8:30, 11:35, 13:10. Day 2 7:30 | Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions. |
| Immune Function: Tumor Necrosis Factor-alpha (TNF-α) | Day 1 8:30, 11:35, 13:10. Day 2 7:30 | Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 7:55 at each of the three visits, scheduled at least 2 weeks apart | — |
| Mood: Positive and Negative Affect Schedule (PANAS)Positive | 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart | 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. |
| Mood: Positive and Negative Affect Schedule (PANAS)Negative | 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart | 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. |
| Heart Rate | Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15 | — |
Countries
United States
Participant flow
Recruitment details
Women were recruited through online ads and notices posted in yoga studios. All women participated in some form of hatha yoga.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Session 1 | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants |
| Age, Continuous | 41.32 years STANDARD_DEVIATION 10.33 |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 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 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
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.
Time frame: 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.
Time frame: 8:30, 10:05, 10:28, 10:58, 11:35, 12:05
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.
Time frame: Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 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
Time frame: 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).
Time frame: 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).
Time frame: Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30
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.
Time frame: 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.
Time frame: Day 1 8:30, 11:35, 13:10. Day 2 7:30
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.
Time frame: 8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novice | Number of Participants With Detectable C-Reactive Protein (CRP) | 16 participants with CRP above 0.3 |
| Expert | Number of Participants With Detectable C-Reactive Protein (CRP) | 8 participants with CRP above 0.3 |
Comparison: hsCRP dichotomized as undetectable/detectable. Logistic regression w/generalized estimating equations(GEE)s to determine odds ratio. Assessed hsCRP at baseline at each of the three visits; 43% of the values (n = 65) were below the assay's detectable lower bound of .3 mg/dL, and thus hsCRP was dichotomized as undetectable/detectable.p-value: 0.009Regression, Logistic
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.
Time frame: 11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart
Secondary
Blood Pressure
Time frame: 7:55 at each of the three visits, scheduled at least 2 weeks apart
Secondary
Heart Rate
Time frame: Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15
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.
Time frame: 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)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.
Time frame: 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart