Clinical trial NCT00371397: Yoga, Immune Function, and Health
Official title: Psychoneuroimmunology and Mind-Body Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: yoga
immune function
stress
health
mood
skin barrier repair
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-09-04
Enrollment: 52
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Detectable C-Reactive Protein (CRP)
timeFrame: 8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart
measure: Cortisol
timeFrame: Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30
measure: Skin Barrier Repair: Trans-epidermal Water Loss (TEWL)
timeFrame: 11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart
measure: Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)
timeFrame: Day 1 8:30, 11:35, 13:10. Day 2 7:30
measure: Immune Function: Tumor Necrosis Factor-alpha (TNF-α)
timeFrame: Day 1 8:30, 11:35, 13:10. Day 2 7:30
measure: Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6)
timeFrame: Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30
measure: Immune Function: LPS-stimulated Production of TNF-α
timeFrame: Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30
measure: Immune Function: Interleukin-6 (IL-6)
timeFrame: Day 1 8:30, 11:35, 13:10. Day 2 7:30
measure: Catecholamine Production: Epinephrine
timeFrame: 8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart
measure: Catecholamine Production: Norepinephrine
timeFrame: 8:30, 10:05, 10:28, 10:58, 11:35, 12:05
Secondary outcomes:
measure: Heart Rate
timeFrame: Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15
measure: Blood Pressure
timeFrame: 7:55 at each of the three visits, scheduled at least 2 weeks apart
measure: Mood: Positive and Negative Affect Schedule (PANAS)Positive
timeFrame: 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart
measure: Mood: Positive and Negative Affect Schedule (PANAS)Negative
timeFrame: 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Clinical Research Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Janice K. Kiecolt-Glaser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.