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Completed

NCT Number: NCT00371397

Yoga, Immune Function, and Health

This study is designed to examine the impact of hatha yoga on immune and hormonal functioning in healthy individuals.

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Key information

Conditions

Healthy

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Clinical Research Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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

  9. 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.

  10. 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.

Secondary outcomes

  1. Heart Rate

    Time frame: Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15

  2. Blood Pressure

    Time frame: 7:55 at each of the three visits, scheduled at least 2 weeks apart

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Psychoneuroimmunology and Mind-Body Interventions

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 4, 2006
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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