Yoga, Immune Function, and Health

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00371397
First received: August 31, 2006
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention
Healthy
Behavioral: Hatha Yoga Classes
Behavioral: Movement Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Psychoneuroimmunology and Mind-Body Interventions

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Heart Rate [ Time Frame: Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15 ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 7:55 at each of the three visits, scheduled at least 2 weeks apart ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 52
Study Start Date: September 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371397

Locations
United States, Ohio
Ohio State University Clinical Research Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Janice K. Kiecolt-Glaser, PhD Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: Janice Kiecolt-Glaser, PhD, Ohio State University Department of Psychiatry
ClinicalTrials.gov Identifier: NCT00371397     History of Changes
Other Study ID Numbers: 2005H0068, R21AT002971-01
Study First Received: August 31, 2006
Results First Received: September 16, 2009
Last Updated: June 7, 2011
Health Authority: United States: Federal Government

Keywords provided by Ohio State University:
yoga
immune function
stress
health
mood
skin barrier repair

ClinicalTrials.gov processed this record on September 16, 2014