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Yoga, Immune Function, and Health

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ClinicalTrials.gov Identifier: NCT00371397
Recruitment Status : Completed
First Posted : September 4, 2006
Results First Posted : July 6, 2011
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Janice Kiecolt-Glaser, Ohio State University

Tracking Information
First Submitted Date  ICMJE August 31, 2006
First Posted Date  ICMJE September 4, 2006
Results First Submitted Date  ICMJE September 16, 2009
Results First Posted Date  ICMJE July 6, 2011
Last Update Posted Date July 6, 2016
Study Start Date  ICMJE September 2005
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
  • Number of Participants With Detectable C-Reactive Protein (CRP) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
  • Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ 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 ]
    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.
  • Catecholamine Production: Norepinephrine [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2006)
  • cortisol and catecholamine production
  • immune function
  • skin barrier repair
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
  • Heart Rate [ Time Frame: Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15 ]
  • Blood Pressure [ Time Frame: 7:55 at each of the three visits, scheduled at least 2 weeks apart ]
  • Mood: Positive and Negative Affect Schedule (PANAS)Positive [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2006)
  • Heart Rate
  • Blood Pressure
  • mood
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoga, Immune Function, and Health
Official Title  ICMJE Psychoneuroimmunology and Mind-Body Interventions
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Behavioral: Hatha 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).
  • Behavioral: Movement 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.
Study Arms  ICMJE
  • Experimental: Hatha yoga classes
    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.
    Intervention: Behavioral: Hatha Yoga Classes
  • Sham Comparator: Movement Control
    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.
    Intervention: Behavioral: Movement Control
  • No Intervention: Passive Video Control
    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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2011)
52
Original Enrollment  ICMJE
 (submitted: August 31, 2006)
50
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00371397
Other Study ID Numbers  ICMJE 2005H0068
R21AT002971-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janice Kiecolt-Glaser, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Janice K. Kiecolt-Glaser, PhD Ohio State University
PRS Account Ohio State University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP